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AdaptResponse Clinical Trial

Primary Purpose

Heart Failure With Left Bundle Branch Block

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
aCRT ON
aCRT OFF
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Left Bundle Branch Block focused on measuring AdaptivCRT, aCRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject is willing to sign and date the study Patient Informed Consent Form.
  • Subject is indicated for a CRT device according to local guidelines.
  • Sinus Rhythm at time of enrollment
  • Complete Left Bundle Branch Block (LBBB) as documented on an ECG (within 30 days prior to enrollment). Strauss Criteria used for LBBB.
  • Intrinsic, normal AV conduction as documented on an ECG by a PR interval less than or equal to 200ms (within 30 days prior to enrollment).
  • Left ventricular ejection fraction less than or equal to 35% (documented within 180 days prior to enrollment).
  • NYHA class II, III or IV (documented within 30 days prior to enrollment) despite optimal medical therapy. Optimal medical therapy is defined as maximal tolerated dose of Beta-blockers and a therapeutic dose of ACE-I, ARB or Aldosterone Antagonist.

Exclusion Criteria:

  • Subject is less than 18 years of age (or has not reached minimum age per local law).
  • Subject is not expected to remain available for at least 2 years of follow-up visits.
  • Subject has permanent atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted
  • Subject is, or previously has been, receiving cardiac resynchronization therapy.
  • Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
  • Subject has unstable angina, or experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within 30 days prior to enrollment.
  • Subject has a mechanical tricuspid heart valve or is scheduled to undergo valve repair or valve replacement during the course of the study.
  • Subject is post heart transplant (subjects on the heart transplant list for the first time are not excluded).
  • Subject has a limited life expectancy due to non-cardiac causes that would not allow completion of the study.
  • Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to device implant).
  • Subject meets any exclusion criteria required by local law.

Sites / Locations

  • CardioVascular Associates of Mesa
  • Phoenix Cardiovascular Research Group, LLC
  • Saint Vincent Heart Clinic Arkansas
  • Scripps Green Hospital Scripps Clinic Torrey Pines
  • Cedars-Sinai Medical Center
  • Coggins & Levy Medical Associates
  • Stanford Hospital & Clinics
  • Saint Joseph's Medical Center
  • Penrose Hospital
  • Medical Center of the Rockies
  • Bridgeport Hospital
  • Washington Hospital Center
  • Heart & Vascular Institute of Florida
  • Florida Heart Rhythm Specialists PLLC
  • The Cardiac & Vascular Institute
  • First Coast Cardiovascular Institute PA
  • Cardiovascular Research Center of South Florida
  • AdventHealth Cardiovascular Research Institute
  • Cardiology Institute of Northwest Florida
  • University of South Florida Health (USF)
  • Emory University Hospital Midtown
  • Piedmont Heart Institute
  • Northwerstern University
  • Prairie Education and Research Cooperative
  • Saint Francis Medical Group Indiana Heart Physician
  • Ochsner Medical Center
  • MedStar Health Research Institute
  • Massachusetts General Hospital (Boston MA)
  • University of Michigan
  • Sparrow Clinical Research Institute
  • William Beaumont Hospital
  • Michigan Heart
  • University of Minnesota Medical Center Fairview
  • North Memorial Heart and Vascular Institute
  • United Heart and Vascular Clinic
  • Mid America Heart Institute (MAHI)
  • Washington University School of Medicine
  • Glacier View Research Institute Cardiology
  • Lourdes Cardiology Services
  • Presbyterian Heart Group
  • New York Methodist Hospital
  • Icahn School of Medicine at Mount Sinai
  • NYU Langone Medical Center
  • Weill Medical College of Cornell University
  • Hudson Valley Heart Center
  • Stony Brook University Medical Center
  • Central New York Cardiology
  • Asheville Cardiology Associate PA
  • Duke University Medical Center (DUMC)
  • Wake Forest Baptist Health High Point Medical Center
  • Raleigh Cardiology Associates
  • Bethesda North Hospital
  • The Lindner Research Center
  • Cleveland Clinic
  • University Hospitals Case Medical Center
  • OhioHealth Research Institute
  • Mount Carmel East
  • The Ohio State University
  • North Ohio Heart-Elyria
  • Oklahoma Heart Hospital Research Foundation
  • Sacred Heart Medical Center
  • Lehigh Valley Hospital
  • Capital Area Research
  • Lancaster General Hospital
  • Mercer Bucks Cardiology
  • Thomas Jefferson University Hospital
  • University of Pennsylvania
  • University of Pittsburgh Medical Center UPMC Presbyterian
  • Great Valley Cardiology
  • Medical University of South Carolina (MUSC)
  • Sutherland Cardiology Clinic
  • Centennial Heart Cardiovascular Consultants LLC
  • Vanderbilt University Medical Center
  • Texas Cardiac Arrhythmia Research
  • The University of Texas (UT) Southwestern Medical Center
  • CHI St. Luke's Heath Baylor College of Medicine Medical Center
  • Baylor Research Institute
  • EP Heart LLC
  • Tyler Cardiovascular Consultants
  • University of Utah
  • The University of Vermont Medical Center Inc
  • University of Virginia Medical Center
  • Sentara Norfolk General Hospital
  • Virginia Cardiovascular Specialists PC
  • Virginia Commonwealth University Health System
  • Swedish Medical Center Cherry Hill
  • Providence Spokane Cardiology
  • CAMC Health Education & Research Institute Inc
  • Medical College of Wisconsin
  • Aurora Cardiovascular Services
  • John Hunter Hospital
  • Austin Hospital
  • Fiona Stanley Hospital
  • Saint Vincent's Hospital (Sydney)
  • Landeskrankenhaus Innsbruck - Universitätskliniken
  • Allgemeines Krankenhaus der Stadt Linz
  • AZ Sint-Jan Brugge-Oostende av
  • Ziekenhuis Oost Limburg - Campus St.-Jan
  • London Health Sciences Centre - University Campus
  • McGill Universtiy Health Centre (MUHC)
  • Southlake Regional Health Centre
  • University of Ottawa Heart Institute
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
  • Royal Columbian Hospital
  • Vancouver General Hospital
  • Odense Universitetshospital
  • Keski-Suomen Keskussairaala
  • Satakunnan keskussairaala
  • Centre Hospitalier Universitaire de Amiens - Hôpital SU
  • CHRU Tours - Hôpital Trousseau
  • Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
  • Centre Hospitalier Sud Francilien
  • CHRU La Rochelle
  • Centre Hospitalier Universitaire de Grenoble-Hopital Albert Michallon
  • CHRU de Lille
  • groupe Hospitalier de L'Institut Catholique de Lille - Hôpital Saint-Philibert
  • Hopital prive Clairval - Ramsay Sante
  • Hôpital de la Timone - Centre Hospitalier Universitaire de Marseille
  • Institut Hospitalier Jacques Cartier
  • CHR Metz-Thionville Hôpital de Mercy
  • CHRU de Montpellier - Hôpital Arnaud de Villeneuve
  • Nouvelles Cliniques Nantaises
  • CMC-Clinique Ambroise Pare
  • Hôpital Pontchaillou - CHU de Rennes
  • CHU Toulouse - Hôpital Rangueil
  • Immanuel Diakonie Group - Evangelisch-Freikirchlichen Krankenhaus und Herzzentrum Brandenburg
  • Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
  • MVZ am Küchwald GmbH ambulantes Herz Zentrum Chemnitz
  • Klinikum Coburg GmbH
  • Praxisklinik Herz und Gefässe - Akademische Lehrpraxisklinik der TU Dresden
  • Universitätsklinikum Düsseldorf
  • Universitätsklinikum Heidelberg
  • Universitätskliniken des Saarlandes
  • Universitätsklinikum Jena - Friedrich Schiller Universität
  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck
  • Märkische Gesundheitsholding GmbH & Co. KG - Klinikum Lüdenscheid
  • Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH
  • Otto von Guericke Universität - Universitätsklinikum Magdeburg A.ö.R.
  • Kliniken Maria Hilf GmbH Mönchengladbach - Krankenhaus St. Franziskus
  • Klinikum der Universität München - Campus Großhadern
  • Herz Riesa, Gemeinschaftspraxis
  • Universitätsklinikum Ulm
  • Magyar Honvédség Honvédkorház
  • Semmelweis Egyetem AOK
  • Medanta - The Medicity
  • Fortis Escorts Heart Institute
  • Policlinico Sant' Orsola - Malpighi
  • Azienda Ospedaliera Spedali Civili di Brescia
  • Ospedale Civile Madonna Della Navicella
  • Azienda Ospedaliera Carlo Poma
  • Azienda Ospedaliero-Universitaria di Parma
  • Azienda Ospedaliera Universitaria Integrata Verona
  • Hirosaki University Hospital
  • Chiba University Hospital
  • Kokura Memorial Hospital
  • Kyorin University Hospital
  • Nagoya University Hospital
  • Sakakibara Heart Institute of Okayama
  • Saitama Medical Center Jichi Medical University
  • National Cerebral and Cardiovascular Center
  • Fujita Health University Hospital
  • University of Fukui Hospital
  • Keimyung University Dongsan Medical Center
  • Yeungnam University Medical Center
  • Seoul National University Bundang Hospital
  • Kyung Hee University Hospital
  • Samsung Medical Center
  • Seoul National University Hospital
  • Hospital Angeles Leon
  • Academisch Medisch Centrum
  • Amphia Ziekenhuis - Locatie Molengracht Breda
  • Medisch Centrum Leeuwarden
  • Canisius-Wilhelmina ziekenhuis
  • Maasstad Ziekenhuis
  • Erasmus Medisch Centrum
  • Universitair Medisch Centrum Utrecht
  • Isala Klinieken - Locatie Weezenlanden
  • Helse Bergen HF - Haukeland Universitetssjukehus
  • Wojewódzki Szpital Zespolony im. Ludwika Perzyny w Kaliszu
  • Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
  • Regional Hospital Szpital Wojewodski
  • Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego
  • Spital Wojewodzki nr 2
  • Slaskie Centrum Chorob Serca
  • Unidade Local de Saude do Baixo Alentejo, EPE - Hospital José Joaquim Fernandes
  • Centro Hospitalar de Coimbra
  • Hospital de Espírito Santo E.P.E.
  • The Arrhythmia Group
  • Cardiovascular Center
  • AV Vishnevsky Institute of Surgery of the Ministry of Health of the Russian Federation
  • EN Meshalkin National medical research center of the Ministry of Health of the Russian Federation
  • Almazov National Medical Research Centre
  • King Abdul Aziz University Hospital
  • King Fahad Armed Forces Hospital
  • King Faisal Specialist Hospital & Research Center
  • The College of Medicine & King Khalid University Hospital, King Saud University
  • Stredoslovensky ustav srdcovych a cievnych chorob a.s
  • NUSCH, a.s.
  • Hospital Universitario Infanta Cristina
  • Nuevo Hospital de Burgos
  • Hospital Virgen de la Arrixaca
  • Hospital Universitario Virgen de las Nieves
  • Hospital Clínico Virgen de la Victoria
  • Hospital Clinico Universitario de Salamanca
  • Hospital Universitario Nuestra Señora de Candelaria
  • Hospital Universitario Virgen del Rocío
  • Complexo Hospitalario Universitario de Vigo - Hospital Xeral Cíes
  • Hospital Universitario Miguel Servet
  • Karolinska Universitetssjukhuset
  • Akademiska Sjukhuset
  • Universitätsspital Basel
  • HFR Fribourg - Hôpital cantonal
  • Kantonsspital St.Gallen
  • National Taiwan University Hospital Hsin Chu Branch
  • National Taiwan University Hospital
  • Golden Jubilee National Hospital - NHS Trust
  • Liverpool Heart and Chest Hospital NHS Foundation Trust
  • University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital
  • Royal Brompton & Harefield NHS Foundation Trust - Royal Brompton Hospital
  • Manchester University NHS Foundation Trust - Wythenshawe Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

aCRT ON

aCRT OFF

Arm Description

The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise

Standard CRT

Outcomes

Primary Outcome Measures

Combined endpoint of all-cause mortality and intervention for heart failure decompensation
Intervention for heart failure decompensation is defined as an event requiring invasive intervention or inpatient hospitalization.

Secondary Outcome Measures

All-cause mortality
Percent of patients with interventions for heart failure decompensation
Intervention for heart failure decompensation is defined as an event requiring invasive intervention or inpatient hospitalization.
Clinical Composite Score
The Clinical Composite Score classifies patients according their clinical status at 6 months post randomization into categories Improved, Unchanged, and Worsened. A patient is classified Worsened in case of death, hospitalization for worsening heart failure, worsened NYHA class (using last observation carried forward), or worsened status on the Global Assessment Score. Also patients that exit the study or cross over because of worsening heart failure are classified Worsened. A patient is classified Improved when not Worsened and there is an improvement in NYHA class or Global Assessment Score. Patients that are not Worsened or Improved are Unchanged.
Atrial fibrillation
Incidence of atrial fibrillation lasting >6 hours in one day
Change in Quality of Life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
The overall summary score of the Kansas City Cardiomyopathy Questionnaire will be analyzed.
Change in Quality of Life measured by the EQ-5D
The EQ-5D index score will be analyzed.
All-cause re-admissions within 30-days after a heart failure admission

Full Information

First Posted
July 18, 2014
Last Updated
January 26, 2023
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT02205359
Brief Title
AdaptResponse Clinical Trial
Official Title
AdaptResponse Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
November 2, 2022 (Actual)
Study Completion Date
November 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this clinical study is to test the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) conduction and left bundle branch block (LBBB).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Left Bundle Branch Block
Keywords
AdaptivCRT, aCRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3797 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aCRT ON
Arm Type
Experimental
Arm Description
The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise
Arm Title
aCRT OFF
Arm Type
Active Comparator
Arm Description
Standard CRT
Intervention Type
Device
Intervention Name(s)
aCRT ON
Intervention Description
CRT device with AdaptivCRT enabled
Intervention Type
Device
Intervention Name(s)
aCRT OFF
Intervention Description
CRT device with AdaptivCRT disabled
Primary Outcome Measure Information:
Title
Combined endpoint of all-cause mortality and intervention for heart failure decompensation
Description
Intervention for heart failure decompensation is defined as an event requiring invasive intervention or inpatient hospitalization.
Time Frame
2 years post randomization
Secondary Outcome Measure Information:
Title
All-cause mortality
Time Frame
2 years post randomization
Title
Percent of patients with interventions for heart failure decompensation
Description
Intervention for heart failure decompensation is defined as an event requiring invasive intervention or inpatient hospitalization.
Time Frame
2 years post randomization
Title
Clinical Composite Score
Description
The Clinical Composite Score classifies patients according their clinical status at 6 months post randomization into categories Improved, Unchanged, and Worsened. A patient is classified Worsened in case of death, hospitalization for worsening heart failure, worsened NYHA class (using last observation carried forward), or worsened status on the Global Assessment Score. Also patients that exit the study or cross over because of worsening heart failure are classified Worsened. A patient is classified Improved when not Worsened and there is an improvement in NYHA class or Global Assessment Score. Patients that are not Worsened or Improved are Unchanged.
Time Frame
6 months post randomization
Title
Atrial fibrillation
Description
Incidence of atrial fibrillation lasting >6 hours in one day
Time Frame
2 years post randomization
Title
Change in Quality of Life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
The overall summary score of the Kansas City Cardiomyopathy Questionnaire will be analyzed.
Time Frame
Baseline to 2 years post randomization
Title
Change in Quality of Life measured by the EQ-5D
Description
The EQ-5D index score will be analyzed.
Time Frame
Baseline to 2 years post randomization
Title
All-cause re-admissions within 30-days after a heart failure admission
Time Frame
2 years post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is willing to sign and date the study Patient Informed Consent Form. Subject is indicated for a CRT device according to local guidelines. Sinus Rhythm at time of enrollment Complete Left Bundle Branch Block (LBBB) as documented on an ECG (within 30 days prior to enrollment). Strauss Criteria used for LBBB. Intrinsic, normal AV conduction as documented on an ECG by a PR interval less than or equal to 200ms (within 30 days prior to enrollment). Left ventricular ejection fraction less than or equal to 35% (documented within 180 days prior to enrollment). NYHA class II, III or IV (documented within 30 days prior to enrollment) despite optimal medical therapy. Optimal medical therapy is defined as maximal tolerated dose of Beta-blockers and a therapeutic dose of ACE-I, ARB or Aldosterone Antagonist. Exclusion Criteria: Subject is less than 18 years of age (or has not reached minimum age per local law). Subject is not expected to remain available for at least 2 years of follow-up visits. Subject has permanent atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted Subject is, or previously has been, receiving cardiac resynchronization therapy. Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager. Subject has unstable angina, or experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within 30 days prior to enrollment. Subject has a mechanical tricuspid heart valve or is scheduled to undergo valve repair or valve replacement during the course of the study. Subject is post heart transplant (subjects on the heart transplant list for the first time are not excluded). Subject has a limited life expectancy due to non-cardiac causes that would not allow completion of the study. Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to device implant). Subject meets any exclusion criteria required by local law.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Wilkoff, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
CardioVascular Associates of Mesa
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Phoenix Cardiovascular Research Group, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018-3956
Country
United States
Facility Name
Saint Vincent Heart Clinic Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205-6202
Country
United States
Facility Name
Scripps Green Hospital Scripps Clinic Torrey Pines
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-1027
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048-5913
Country
United States
Facility Name
Coggins & Levy Medical Associates
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
Facility Name
Stanford Hospital & Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305-2200
Country
United States
Facility Name
Saint Joseph's Medical Center
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Facility Name
Penrose Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907-6863
Country
United States
Facility Name
Medical Center of the Rockies
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Bridgeport Hospital
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606-4284
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-3017
Country
United States
Facility Name
Heart & Vascular Institute of Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756-3367
Country
United States
Facility Name
Florida Heart Rhythm Specialists PLLC
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
The Cardiac & Vascular Institute
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
First Coast Cardiovascular Institute PA
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256-6954
Country
United States
Facility Name
Cardiovascular Research Center of South Florida
City
Miami
State/Province
Florida
Country
United States
Facility Name
AdventHealth Cardiovascular Research Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803-1248
Country
United States
Facility Name
Cardiology Institute of Northwest Florida
City
Panama City
State/Province
Florida
ZIP/Postal Code
32401-3665
Country
United States
Facility Name
University of South Florida Health (USF)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308-2225
Country
United States
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Northwerstern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Prairie Education and Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62769-0002
Country
United States
Facility Name
Saint Francis Medical Group Indiana Heart Physician
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237-6345
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121-2429
Country
United States
Facility Name
MedStar Health Research Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237-3958
Country
United States
Facility Name
Massachusetts General Hospital (Boston MA)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-2621
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5853
Country
United States
Facility Name
Sparrow Clinical Research Institute
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
William Beaumont Hospital
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098-6375
Country
United States
Facility Name
Michigan Heart
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197-8633
Country
United States
Facility Name
University of Minnesota Medical Center Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
North Memorial Heart and Vascular Institute
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422-2926
Country
United States
Facility Name
United Heart and Vascular Clinic
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102-2568
Country
United States
Facility Name
Mid America Heart Institute (MAHI)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1010
Country
United States
Facility Name
Glacier View Research Institute Cardiology
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Lourdes Cardiology Services
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043-4322
Country
United States
Facility Name
Presbyterian Heart Group
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106-4921
Country
United States
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
Country
United States
Facility Name
Hudson Valley Heart Center
City
Poughkeepsie
State/Province
New York
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
Country
United States
Facility Name
Central New York Cardiology
City
Utica
State/Province
New York
Country
United States
Facility Name
Asheville Cardiology Associate PA
City
Asheville
State/Province
North Carolina
Country
United States
Facility Name
Duke University Medical Center (DUMC)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Wake Forest Baptist Health High Point Medical Center
City
High Point
State/Province
North Carolina
Country
United States
Facility Name
Raleigh Cardiology Associates
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Bethesda North Hospital
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
The Lindner Research Center
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
OhioHealth Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Mount Carmel East
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
North Ohio Heart-Elyria
City
Elyria
State/Province
Ohio
Country
United States
Facility Name
Oklahoma Heart Hospital Research Foundation
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Sacred Heart Medical Center
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
Country
United States
Facility Name
Capital Area Research
City
Camp Hill
State/Province
Pennsylvania
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Facility Name
Mercer Bucks Cardiology
City
Newtown
State/Province
Pennsylvania
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
University of Pittsburgh Medical Center UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Great Valley Cardiology
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18510
Country
United States
Facility Name
Medical University of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Sutherland Cardiology Clinic
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Centennial Heart Cardiovascular Consultants LLC
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research
City
Austin
State/Province
Texas
Country
United States
Facility Name
The University of Texas (UT) Southwestern Medical Center
City
Dallas
State/Province
Texas
Country
United States
Facility Name
CHI St. Luke's Heath Baylor College of Medicine Medical Center
City
Houston
State/Province
Texas
Country
United States
Facility Name
Baylor Research Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
EP Heart LLC
City
The Woodlands
State/Province
Texas
Country
United States
Facility Name
Tyler Cardiovascular Consultants
City
Tyler
State/Province
Texas
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
The University of Vermont Medical Center Inc
City
Burlington
State/Province
Vermont
Country
United States
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Virginia Cardiovascular Specialists PC
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Virginia Commonwealth University Health System
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Swedish Medical Center Cherry Hill
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Providence Spokane Cardiology
City
Spokane
State/Province
Washington
Country
United States
Facility Name
CAMC Health Education & Research Institute Inc
City
Charleston
State/Province
West Virginia
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States
Facility Name
Aurora Cardiovascular Services
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
John Hunter Hospital
City
New Lambton
State/Province
New South Wales
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
Country
Australia
Facility Name
Saint Vincent's Hospital (Sydney)
City
Sydney
Country
Australia
Facility Name
Landeskrankenhaus Innsbruck - Universitätskliniken
City
Innsbruck
Country
Austria
Facility Name
Allgemeines Krankenhaus der Stadt Linz
City
Linz
Country
Austria
Facility Name
AZ Sint-Jan Brugge-Oostende av
City
Brugge
Country
Belgium
Facility Name
Ziekenhuis Oost Limburg - Campus St.-Jan
City
Genk
Country
Belgium
Facility Name
London Health Sciences Centre - University Campus
City
London
Country
Canada
Facility Name
McGill Universtiy Health Centre (MUHC)
City
Montreal
Country
Canada
Facility Name
Southlake Regional Health Centre
City
Newmarket
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
City
Quebec
Country
Canada
Facility Name
Royal Columbian Hospital
City
Vancouver
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
Country
Canada
Facility Name
Odense Universitetshospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Keski-Suomen Keskussairaala
City
Jyväskylä
Country
Finland
Facility Name
Satakunnan keskussairaala
City
Pori
Country
Finland
Facility Name
Centre Hospitalier Universitaire de Amiens - Hôpital SU
City
Amiens
Country
France
Facility Name
CHRU Tours - Hôpital Trousseau
City
Chambray lès tours
Country
France
Facility Name
Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
City
Clermont-Ferrand
Country
France
Facility Name
Centre Hospitalier Sud Francilien
City
Corbeil-Essonnes
Country
France
Facility Name
CHRU La Rochelle
City
La Rochelle
ZIP/Postal Code
17019
Country
France
Facility Name
Centre Hospitalier Universitaire de Grenoble-Hopital Albert Michallon
City
La Tronche
Country
France
Facility Name
CHRU de Lille
City
Lille
Country
France
Facility Name
groupe Hospitalier de L'Institut Catholique de Lille - Hôpital Saint-Philibert
City
Lomme
Country
France
Facility Name
Hopital prive Clairval - Ramsay Sante
City
Marseille
Country
France
Facility Name
Hôpital de la Timone - Centre Hospitalier Universitaire de Marseille
City
Marseille
Country
France
Facility Name
Institut Hospitalier Jacques Cartier
City
Massy
Country
France
Facility Name
CHR Metz-Thionville Hôpital de Mercy
City
Metz
Country
France
Facility Name
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
City
Montpellier Cedex 5
Country
France
Facility Name
Nouvelles Cliniques Nantaises
City
Nantes
Country
France
Facility Name
CMC-Clinique Ambroise Pare
City
Neuilly-sur-Seine
Country
France
Facility Name
Hôpital Pontchaillou - CHU de Rennes
City
Rennes Cedex 9
Country
France
Facility Name
CHU Toulouse - Hôpital Rangueil
City
Toulouse Cedex 9
Country
France
Facility Name
Immanuel Diakonie Group - Evangelisch-Freikirchlichen Krankenhaus und Herzzentrum Brandenburg
City
Bernau bei Berlin
Country
Germany
Facility Name
Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
City
Bochum
Country
Germany
Facility Name
MVZ am Küchwald GmbH ambulantes Herz Zentrum Chemnitz
City
Chemnitz
Country
Germany
Facility Name
Klinikum Coburg GmbH
City
Coburg
Country
Germany
Facility Name
Praxisklinik Herz und Gefässe - Akademische Lehrpraxisklinik der TU Dresden
City
Dresden
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Universitätskliniken des Saarlandes
City
Homburg/Saar
Country
Germany
Facility Name
Universitätsklinikum Jena - Friedrich Schiller Universität
City
Jena
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
City
Lübeck
Country
Germany
Facility Name
Märkische Gesundheitsholding GmbH & Co. KG - Klinikum Lüdenscheid
City
Lüdenscheid
ZIP/Postal Code
58515
Country
Germany
Facility Name
Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH
City
Lüdenscheid
Country
Germany
Facility Name
Otto von Guericke Universität - Universitätsklinikum Magdeburg A.ö.R.
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Kliniken Maria Hilf GmbH Mönchengladbach - Krankenhaus St. Franziskus
City
Mönchengladbach
Country
Germany
Facility Name
Klinikum der Universität München - Campus Großhadern
City
München
Country
Germany
Facility Name
Herz Riesa, Gemeinschaftspraxis
City
Riesa
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89801
Country
Germany
Facility Name
Magyar Honvédség Honvédkorház
City
Budapest
Country
Hungary
Facility Name
Semmelweis Egyetem AOK
City
Budapest
Country
Hungary
Facility Name
Medanta - The Medicity
City
Gurgaon
Country
India
Facility Name
Fortis Escorts Heart Institute
City
New Delhi
Country
India
Facility Name
Policlinico Sant' Orsola - Malpighi
City
Bologna
Country
Italy
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia
City
Brescia
Country
Italy
Facility Name
Ospedale Civile Madonna Della Navicella
City
Chioggia
Country
Italy
Facility Name
Azienda Ospedaliera Carlo Poma
City
Mantova
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Parma
City
Parma
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona
City
Verona
Country
Italy
Facility Name
Hirosaki University Hospital
City
Hirosaki
State/Province
Aomori Prefecture
Country
Japan
Facility Name
Chiba University Hospital
City
Chiba-Shi
Country
Japan
Facility Name
Kokura Memorial Hospital
City
Kitakyushu
Country
Japan
Facility Name
Kyorin University Hospital
City
Mitaka-Shi
Country
Japan
Facility Name
Nagoya University Hospital
City
Nagoya
Country
Japan
Facility Name
Sakakibara Heart Institute of Okayama
City
Okayama-Shi
Country
Japan
Facility Name
Saitama Medical Center Jichi Medical University
City
Shimonoseki-Shi
Country
Japan
Facility Name
National Cerebral and Cardiovascular Center
City
Suita-Shi
Country
Japan
Facility Name
Fujita Health University Hospital
City
Toyoake
Country
Japan
Facility Name
University of Fukui Hospital
City
Tsukuba
Country
Japan
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-Do
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hospital Angeles Leon
City
Leon
State/Province
Guanajuato
Country
Mexico
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Amphia Ziekenhuis - Locatie Molengracht Breda
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
Country
Netherlands
Facility Name
Canisius-Wilhelmina ziekenhuis
City
Nijmegen
Country
Netherlands
Facility Name
Maasstad Ziekenhuis
City
Rotterdam
ZIP/Postal Code
3078 HT
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
Country
Netherlands
Facility Name
Isala Klinieken - Locatie Weezenlanden
City
Zwolle
ZIP/Postal Code
8011 JW
Country
Netherlands
Facility Name
Helse Bergen HF - Haukeland Universitetssjukehus
City
Bergen
Country
Norway
Facility Name
Wojewódzki Szpital Zespolony im. Ludwika Perzyny w Kaliszu
City
Kalisz
Country
Poland
Facility Name
Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
City
Katowice
Country
Poland
Facility Name
Regional Hospital Szpital Wojewodski
City
Kielce
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego
City
Lublin
Country
Poland
Facility Name
Spital Wojewodzki nr 2
City
Rzeszów
Country
Poland
Facility Name
Slaskie Centrum Chorob Serca
City
Zabrze
Country
Poland
Facility Name
Unidade Local de Saude do Baixo Alentejo, EPE - Hospital José Joaquim Fernandes
City
Beja
Country
Portugal
Facility Name
Centro Hospitalar de Coimbra
City
Coimbra
ZIP/Postal Code
3041-801
Country
Portugal
Facility Name
Hospital de Espírito Santo E.P.E.
City
Évora
ZIP/Postal Code
7000
Country
Portugal
Facility Name
The Arrhythmia Group
City
Coto Laurel
Country
Puerto Rico
Facility Name
Cardiovascular Center
City
San Juan
Country
Puerto Rico
Facility Name
AV Vishnevsky Institute of Surgery of the Ministry of Health of the Russian Federation
City
Moscow
Country
Russian Federation
Facility Name
EN Meshalkin National medical research center of the Ministry of Health of the Russian Federation
City
Novosibirsk
Country
Russian Federation
Facility Name
Almazov National Medical Research Centre
City
St Petersburg
Country
Russian Federation
Facility Name
King Abdul Aziz University Hospital
City
Jeddah
Country
Saudi Arabia
Facility Name
King Fahad Armed Forces Hospital
City
Jeddah
Country
Saudi Arabia
Facility Name
King Faisal Specialist Hospital & Research Center
City
Riyadh
Country
Saudi Arabia
Facility Name
The College of Medicine & King Khalid University Hospital, King Saud University
City
Riyadh
Country
Saudi Arabia
Facility Name
Stredoslovensky ustav srdcovych a cievnych chorob a.s
City
Banska Bystrica
Country
Slovakia
Facility Name
NUSCH, a.s.
City
Bratislava 37
ZIP/Postal Code
83348
Country
Slovakia
Facility Name
Hospital Universitario Infanta Cristina
City
Badajoz
Country
Spain
Facility Name
Nuevo Hospital de Burgos
City
Burgos
Country
Spain
Facility Name
Hospital Virgen de la Arrixaca
City
El Palmar
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
Country
Spain
Facility Name
Hospital Clínico Virgen de la Victoria
City
Málaga
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital Universitario Nuestra Señora de Candelaria
City
Santa Cruz de Tenerife
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
Country
Spain
Facility Name
Complexo Hospitalario Universitario de Vigo - Hospital Xeral Cíes
City
Vigo
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
Country
Spain
Facility Name
Karolinska Universitetssjukhuset
City
Solna
Country
Sweden
Facility Name
Akademiska Sjukhuset
City
Uppsala
Country
Sweden
Facility Name
Universitätsspital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
HFR Fribourg - Hôpital cantonal
City
Fribourg
Country
Switzerland
Facility Name
Kantonsspital St.Gallen
City
Saint Gallen
Country
Switzerland
Facility Name
National Taiwan University Hospital Hsin Chu Branch
City
Hsinchu
ZIP/Postal Code
30059
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Golden Jubilee National Hospital - NHS Trust
City
Glasgow
Country
United Kingdom
Facility Name
Liverpool Heart and Chest Hospital NHS Foundation Trust
City
Liverpool
Country
United Kingdom
Facility Name
University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital
City
Liverpool
Country
United Kingdom
Facility Name
Royal Brompton & Harefield NHS Foundation Trust - Royal Brompton Hospital
City
London
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust - Wythenshawe Hospital
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32790108
Citation
Wilkoff BL, Birnie D, Gold MR, Hersi AS, Jacobs S, Gerritse B, Kusano K, Leclercq C, Mullens W, Filippatos G. Differences in clinical characteristics and reported quality of life of men and women undergoing cardiac resynchronization therapy. ESC Heart Fail. 2020 Oct;7(5):2972-2982. doi: 10.1002/ehf2.12914. Epub 2020 Aug 13.
Results Reference
derived
PubMed Identifier
28708290
Citation
Filippatos G, Birnie D, Gold MR, Gerritse B, Hersi A, Jacobs S, Kusano K, Leclercq C, Mullens W, Wilkoff BL; AdaptResponse Investigators. Rationale and design of the AdaptResponse trial: a prospective randomized study of cardiac resynchronization therapy with preferential adaptive left ventricular-only pacing. Eur J Heart Fail. 2017 Jul;19(7):950-957. doi: 10.1002/ejhf.895.
Results Reference
derived

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AdaptResponse Clinical Trial

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