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Strategic Management to Optimize Response To Cardiac Resynchronization Therapy (SMART CRT)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CRT-D
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject must be indicated to receive a de novo quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) in conjunction with an ACUITY X4 LV lead. This includes subjects who are indicated to receive an upgrade to a BSC X4 CRT-D from a previously implanted device.

  • In order to achieve a homogenous population for the study, qualifying subjects are those with heart failure who meet BSC US indications for use defined as those subjects who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications:

    • Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms
    • Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure
  • Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws
  • Subject is willing and capable of providing informed consent
  • Subject is willing and capable of complying with visits and procedures as defined by this protocol

Exclusion Criteria:

  • Subjects with documented permanent complete AV block
  • Subjects with permanent or chronic atrial fibrillation (AF) or in AF at the time of enrollment
  • Subjects who have previously received cardiac resynchronization therapy with pacing in the left ventricle
  • Subjects on the active heart transplant list or who has or is to receive ventricular assist device (VAD)
  • Life expectancy shorter than 12 months due to any medical condition (e.g., cancer, uremia, liver failure, etc…)
  • Subject with a known or suspected sensitivity to dexamethasone acetate (DXA)
  • Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific
  • Women of childbearing potential who are or plan to become pregnant during the course of the trial
  • Subjects currently requiring dialysis

Sites / Locations

  • Affinity Hospital, LLC d/b/a Granview Medical Center
  • Heart Center Research LLC
  • University of Arizona Sarver Heart Center
  • Cardiology Associates of NE Arkansas
  • Glendale Adventist Medical Center
  • Salinas Valley Memorial Healthcare System
  • Christiana Care Health Services
  • Baptist Health Research Institute
  • Watson Clinic Center for Research, Inc
  • Winter Haven Hospital
  • Emory University Hospital
  • Northside Hospital
  • The University of Chicago
  • St. John's Hospital
  • Heart Group at Deaconness Hospital
  • University of Iowa Hospitals
  • St. Elizabeth Healthcare
  • Baptist Health Lexington
  • Lahey Hospital and Medical Center
  • Southcoast Health
  • Cardiovascular Institute of Michigan
  • Trinity Health Michigan d/b/a Michigan Heart
  • HealthEast St. Joseph's Hospital
  • The International Heart Institute on Montana Foundation
  • Cardiovascular Associates of the Delaware Valley
  • The Valley Hospital
  • New York Methodist Hospital
  • Novant Health Heart and Vascular Institute
  • Novant Health Forsyth Medical Center
  • The Ohio Health Research Institute- Grant Medical Center
  • Providence Heart Institute
  • Geisinger Clinic
  • University of Pennsylvania
  • Pottstown Medical Specialist, Inc
  • Medical University of South Carolina
  • North Central Heart
  • Dallas VA Research Corporation
  • Michael E. DeBakey VA Medical Center
  • Foundation for Advancing Veterans' Health Research
  • Virginia Commonwealth University Medical Center
  • PeaceHealth Southwest Medical Center
  • Institut universitaire de Cardiologie et de Pneumologie de Quebec
  • Centre hospitalier du pays d'Aix
  • CHU Grenoble
  • CHRU de Lille
  • Hopital Saint Philibert
  • CHRU Hopital Pontchaillou
  • Centre Hôpital Universitaire Rouen, Hôpital Charles Nicolle
  • Centre Hôpital Universitaire Rangueil
  • Unfalkrankenhaus Marzahn
  • University of Berlin, Charite Virchow Standort
  • Uni Jena
  • Krankenhaus Landshut-Achdorf
  • Otto-von-Guericke-Universitaet Magdeburg
  • Mater Misericordiae University Hospital
  • Ospedale S. Orsola - Malpighi
  • Azienda Sanitaria Universtitaria Integrata di Trieste
  • Hirosaki University Hospital
  • Hiroshima Prefectural Hospital
  • Tokyo Medical University Hospital
  • Shinshu University Hospital
  • St. Antonius Ziekenhuis
  • Hospital Infanta Cristina
  • Hospital 12 de Octubre Madrid
  • Hospital Universitario La Fe
  • Cardiocentro Ticino
  • Royal Sussex County Hospital
  • University Hospital of Wales
  • Hammersmith Hospital
  • Freeman Hospital
  • Nottingham University Hospital
  • Southampton University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

SmartDelay™ algorithm

Fixed AV Delay with BiV pacing

Arm Description

Subjects programmed with AV Delay and pacing chamber determined by SmartDelay

Subjects programmed with a Fixed AV Delay of 120ms with BiV pacing

Outcomes

Primary Outcome Measures

CRT Response
Comparing cardiac resynchronization therapy (CRT) response rates between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. A negative change in LVESV is considered an improvement; CRT response is defined by a change in Left Ventricular End Systolic Volume (LVESV) < -15% at 6 months compared to pre-implant baseline.

Secondary Outcome Measures

Change in Left Ventricular End Systolic Volume (Absolute Change)
Comparing absolute changes in Left Ventricular End Systolic Volume from Implant to 6 Months between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. Change is defined as 6-Month measurement - Implant measurement, in milliliters. A negative change in LVESV is considered an improvement.
Change in Left Ventricular End Systolic Volume (Relative Change)
Comparing relative changes in Left Ventricular End Systolic Volume from Implant to 6 Months between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. Change is defined as 100*(6-Month measurement - Implant measurement)/(Implant Measurement), in %. A negative change in LVESV is considered an improvement.
Change in Left Ventricular Ejection Fraction (Absolute Change)
Comparing absolute changes in Left Ventricular Ejection Fraction from Implant to 6 Months between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. Change is defined as 6-Month measurement - Implant measurement, in % of blood ejected during LV contraction. A positive change in LVEF is considered an improvement.
Change in Left Ventricular Ejection Fraction (Relative Change)
Comparing relative changes in Left Ventricular Ejection Fraction from Implant to 6 Months between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. Change is defined as 100*(6-Month measurement - Implant measurement)/(Implant Measurement), in %. A positive change in LVEF is considered an improvement.
Clinical Composite Score (CCS)
Th CCS combines four metrics: all-cause mortality, heart failure hospitalization (HFH), New York Heart Association (NYHA) Class, and quality of life as measured with the patient global assessment (GA) instrument. The CCS categorizes each subject into one of three groups: Improved, Unchanged or Worsened. Improved: Subjects that survived without a HFH through the 6-month visit window and had either an improvement in NYHA class or responded to GA with "much better" or "very much better". Unchanged: All patients that reached the end of 6-month visit window that were not categorized as either "Improved" or "Worsened". Worsened: Subjects that died or had HFH within 6-month visit window or had either a worsening in NYHA class or responded to GA with "much worse" or "very much worse".
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
The KCCQ is a disease-specific instrument for monitoring the health status and quality of life of subjects with congestive heart failure. It includes a total of 23 items that assess quality of life in the following domains: physical function, symptom frequency and severity, symptom stability, self-efficacy and knowledge, social function, and overall quality of life. These domains can be combined into a functional status summary score (derived from the physical function and symptom scales) and an overall summary score which combines the physical function, symptom, social function and quality of life domains. KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.

Full Information

First Posted
March 19, 2017
Last Updated
April 1, 2022
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03089281
Brief Title
Strategic Management to Optimize Response To Cardiac Resynchronization Therapy
Acronym
SMART CRT
Official Title
Strategic Management to Optimize Response To Cardiac Resynchronization Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
September 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients with a prolonged RV-LV interval.
Detailed Description
The primary hypothesis of SMART CRT is that among cardiac resynchronization therapy defibrillator (CRT-D) patients with prolonged inrerventricular delay between the RV and LV leads, CRT with atrioventricular optimization (AVO) will result in greater reverse LV remodeling compared with CRT programmed at nominal settings (120 ms).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
699 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SmartDelay™ algorithm
Arm Type
Other
Arm Description
Subjects programmed with AV Delay and pacing chamber determined by SmartDelay
Arm Title
Fixed AV Delay with BiV pacing
Arm Type
Other
Arm Description
Subjects programmed with a Fixed AV Delay of 120ms with BiV pacing
Intervention Type
Device
Intervention Name(s)
CRT-D
Intervention Description
Commercially approved quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices and future generations of BSC X4 CRT-D devices approved by the appropriate regulatory bodies will be included in the trial. All devices utilized in the study will include SmartDelay™ and must be capable of providing SmartDelay recommendations for both biventricular pacing (BiV) and Left Ventricular (LV) only pacing. All enrolled subjects with implanted BSC X4 CRT-D system and identified with an RV-LV delay of ≥70ms were 1:1 randomized. Randomization occurred in the electronic data capturing system.
Primary Outcome Measure Information:
Title
CRT Response
Description
Comparing cardiac resynchronization therapy (CRT) response rates between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. A negative change in LVESV is considered an improvement; CRT response is defined by a change in Left Ventricular End Systolic Volume (LVESV) < -15% at 6 months compared to pre-implant baseline.
Time Frame
Pre-Implant baseline to 6 months
Secondary Outcome Measure Information:
Title
Change in Left Ventricular End Systolic Volume (Absolute Change)
Description
Comparing absolute changes in Left Ventricular End Systolic Volume from Implant to 6 Months between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. Change is defined as 6-Month measurement - Implant measurement, in milliliters. A negative change in LVESV is considered an improvement.
Time Frame
Implant to 6 Months
Title
Change in Left Ventricular End Systolic Volume (Relative Change)
Description
Comparing relative changes in Left Ventricular End Systolic Volume from Implant to 6 Months between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. Change is defined as 100*(6-Month measurement - Implant measurement)/(Implant Measurement), in %. A negative change in LVESV is considered an improvement.
Time Frame
Implant to 6 Months
Title
Change in Left Ventricular Ejection Fraction (Absolute Change)
Description
Comparing absolute changes in Left Ventricular Ejection Fraction from Implant to 6 Months between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. Change is defined as 6-Month measurement - Implant measurement, in % of blood ejected during LV contraction. A positive change in LVEF is considered an improvement.
Time Frame
Implant to 6 Months
Title
Change in Left Ventricular Ejection Fraction (Relative Change)
Description
Comparing relative changes in Left Ventricular Ejection Fraction from Implant to 6 Months between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. Change is defined as 100*(6-Month measurement - Implant measurement)/(Implant Measurement), in %. A positive change in LVEF is considered an improvement.
Time Frame
Implant to 6 Months
Title
Clinical Composite Score (CCS)
Description
Th CCS combines four metrics: all-cause mortality, heart failure hospitalization (HFH), New York Heart Association (NYHA) Class, and quality of life as measured with the patient global assessment (GA) instrument. The CCS categorizes each subject into one of three groups: Improved, Unchanged or Worsened. Improved: Subjects that survived without a HFH through the 6-month visit window and had either an improvement in NYHA class or responded to GA with "much better" or "very much better". Unchanged: All patients that reached the end of 6-month visit window that were not categorized as either "Improved" or "Worsened". Worsened: Subjects that died or had HFH within 6-month visit window or had either a worsening in NYHA class or responded to GA with "much worse" or "very much worse".
Time Frame
Implant to 6 Months
Title
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Description
The KCCQ is a disease-specific instrument for monitoring the health status and quality of life of subjects with congestive heart failure. It includes a total of 23 items that assess quality of life in the following domains: physical function, symptom frequency and severity, symptom stability, self-efficacy and knowledge, social function, and overall quality of life. These domains can be combined into a functional status summary score (derived from the physical function and symptom scales) and an overall summary score which combines the physical function, symptom, social function and quality of life domains. KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.
Time Frame
Implant to 6 Months
Other Pre-specified Outcome Measures:
Title
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Social Limitation Score
Description
The KCCQ Social Limitation Domain quantifies the extent to which heart failure symptoms impair patients' ability to interact in a number of gender-neutral social activities. KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.
Time Frame
Implant to 6 Months
Title
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Score
Description
KCCQ Quality of Life Domain is designed to reflect patients' assessment of their quality of life, given the current status of their heart failure. KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.
Time Frame
Implant to 6 Months
Title
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Self-Efficacy Score
Description
KCCQ Self-efficacy Domain quantifies patients' perceptions of how to prevent heart failure exacerbations and manage complications when they arise. This scale is not included in the summary scores. KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.
Time Frame
Implant to 6 Months
Title
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Frequency Score
Description
KCCQ Symptom Domain quantifies the frequency of clinical symptoms in heart failure, including fatigue, shortness of breath, paroxysmal nocturnal dyspnea and patients' edema/swelling. KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.
Time Frame
Implant to 6 Months
Title
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Burden Score
Description
KCCQ Symptom Domain quantifies the burden of clinical symptoms in heart failure, including fatigue, shortness of breath, paroxysmal nocturnal dyspnea and patients' edema/swelling. KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.
Time Frame
Implant to 6 Months
Title
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Physical Limitation Score
Description
KCCQ Physical Function Domain measures the limitations patients experience, due to their heart failure symptoms, in performing routine activities. Activities are common, gender-neutral, and generalizable across cultures, while also capturing a range of exertional requirements. KCCQ scores have a minimum of 0 and a maximum of 100. Higher score indicates better quality of life.
Time Frame
Implant to 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject must be indicated to receive a de novo quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) in conjunction with an ACUITY X4 LV lead. This includes subjects who are indicated to receive an upgrade to a BSC X4 CRT-D from a previously implanted device. In order to achieve a homogenous population for the study, qualifying subjects are those with heart failure who meet BSC US indications for use defined as those subjects who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws Subject is willing and capable of providing informed consent Subject is willing and capable of complying with visits and procedures as defined by this protocol Exclusion Criteria: Subjects with documented permanent complete AV block Subjects with permanent or chronic atrial fibrillation (AF) or in AF at the time of enrollment Subjects who have previously received cardiac resynchronization therapy with pacing in the left ventricle Subjects on the active heart transplant list or who has or is to receive ventricular assist device (VAD) Life expectancy shorter than 12 months due to any medical condition (e.g., cancer, uremia, liver failure, etc…) Subject with a known or suspected sensitivity to dexamethasone acetate (DXA) Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific Women of childbearing potential who are or plan to become pregnant during the course of the trial Subjects currently requiring dialysis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R. Gold, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affinity Hospital, LLC d/b/a Granview Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
Heart Center Research LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
University of Arizona Sarver Heart Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Cardiology Associates of NE Arkansas
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Glendale Adventist Medical Center
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Salinas Valley Memorial Healthcare System
City
Salinas
State/Province
California
ZIP/Postal Code
93901
Country
United States
Facility Name
Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Baptist Health Research Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Watson Clinic Center for Research, Inc
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Winter Haven Hospital
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33881
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
St. John's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Heart Group at Deaconness Hospital
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
University of Iowa Hospitals
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
St. Elizabeth Healthcare
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Lahey Hospital and Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Southcoast Health
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Cardiovascular Institute of Michigan
City
Roseville
State/Province
Michigan
ZIP/Postal Code
48066
Country
United States
Facility Name
Trinity Health Michigan d/b/a Michigan Heart
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
HealthEast St. Joseph's Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
The International Heart Institute on Montana Foundation
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Cardiovascular Associates of the Delaware Valley
City
Haddon Heights
State/Province
New Jersey
ZIP/Postal Code
08035
Country
United States
Facility Name
The Valley Hospital
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Novant Health Heart and Vascular Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Novant Health Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
The Ohio Health Research Institute- Grant Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Providence Heart Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Geisinger Clinic
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pottstown Medical Specialist, Inc
City
Pottstown
State/Province
Pennsylvania
ZIP/Postal Code
19464
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
North Central Heart
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Dallas VA Research Corporation
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Foundation for Advancing Veterans' Health Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
PeaceHealth Southwest Medical Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Institut universitaire de Cardiologie et de Pneumologie de Quebec
City
Québec
Country
Canada
Facility Name
Centre hospitalier du pays d'Aix
City
Aix en Provence
ZIP/Postal Code
13616
Country
France
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHRU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Saint Philibert
City
Lille
ZIP/Postal Code
59160
Country
France
Facility Name
CHRU Hopital Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Centre Hôpital Universitaire Rouen, Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Centre Hôpital Universitaire Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Unfalkrankenhaus Marzahn
City
Berlin
ZIP/Postal Code
12683
Country
Germany
Facility Name
University of Berlin, Charite Virchow Standort
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Uni Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Krankenhaus Landshut-Achdorf
City
Landshut
ZIP/Postal Code
84036
Country
Germany
Facility Name
Otto-von-Guericke-Universitaet Magdeburg
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Mater Misericordiae University Hospital
City
Dublin
ZIP/Postal Code
D07 R2WY
Country
Ireland
Facility Name
Ospedale S. Orsola - Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Sanitaria Universtitaria Integrata di Trieste
City
Trieste
ZIP/Postal Code
34129
Country
Italy
Facility Name
Hirosaki University Hospital
City
Hirosaki-shi
State/Province
Aomori
ZIP/Postal Code
036-8562
Country
Japan
Facility Name
Hiroshima Prefectural Hospital
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
734-8530
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Shinshu University Hospital
City
Nagano
Country
Japan
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Hospital Infanta Cristina
City
Badajoz
State/Province
Extremadura
ZIP/Postal Code
06080
Country
Spain
Facility Name
Hospital 12 de Octubre Madrid
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Cardiocentro Ticino
City
Lugano
ZIP/Postal Code
CH-6900
Country
Switzerland
Facility Name
Royal Sussex County Hospital
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
ZIP/Postal Code
CF144XW
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Nottingham University Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Southampton University Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Strategic Management to Optimize Response To Cardiac Resynchronization Therapy

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