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SyncAV Post-Market Trial (SyncAV)

Primary Purpose

Congestive Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SyncAV programmed ON
Fixed AV delay
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring SyncAV feature, CRT optimization, CRT non-responders, ECG optimization, Cardiac remodeling, CRT with SyncAV

Eligibility Criteria

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

Inclusion Criteria:

  1. Scheduled to receive a new CRT implant or an upgrade (Abbott CRT device and Abbott Quadripolar LV lead) from an existing implantable cardioverter defibrillator/pacemaker implant with no more than 10% RV pacing at the last device interrogation, no prior LV lead placement, AND meet the following additional criteria:

    1. Mild to severe heart failure despite optimal medical therapy for at least 3 months prior to signing consent. Optimal medical therapy is defined as maximal tolerated dose of beta-blockers and a therapeutic dose of angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, or aldosterone antagonist
    2. LVEF ≤ 35% based on a prior standard of care echocardiogram
    3. Left bundle branch block (LBBB) as documented on an ECG. Criteria for complete LBBB should include,

    i. QRS duration ≥ 120 ms ii. QS or rS pattern in leads V1 iii. mid-QRS notching or slurring in leads I, aVL, V5, and V6 iv. Absence of Q-wave in leads V5 and V6 d. Intact AV conduction (PR interval ≤ 280 ms on surface ECG)

  2. At least 18 years old, or of legal age and willing and capable to give informed consent specific to each country and national laws
  3. Willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria:

  1. Recent myocardial infarction or unstable angina within 40 days prior to signing consent
  2. Recent cardiac revascularization (angioplasty, stent or bypass graft) in the 4 weeks prior to signing consent or planned within 3 months following consent
  3. Cerebrovascular accident or transient ischemic attack in the 3 months prior to signing consent
  4. Any other therapeutic cardiovascular procedure (transcatheter aortic valve replacement, MitraClip, cardiac surgery, left atrial appendage closure, patent foramen ovale closure, or any ablation procedures) in the 3 months prior to signing consent
  5. Permanent or persistent AF at the time of signing consent
  6. Paroxysmal AF with at least one cardioversion within 60 days prior to signing consent
  7. Prior CRT device implant
  8. Prior His Bundle pacing implant or plan to have His Bundle pacing implant
  9. Pregnant or breastfeeding at the time of signing consent
  10. Incapacitated or unable to read or write
  11. Undergone cardiac transplantation or have a classification of Status 1 for cardiac transplantation or consideration for transplantation during the study follow-up period
  12. Life expectancy < 12 months due to any condition
  13. Unavailable for at least 12 months of follow-up visits
  14. Enrolled in or intend to participate in a clinical drug and/or device study during this clinical trial which could confound the results of this trial as determined by Abbott

Sites / Locations

  • Heart Center Research, LLC.Recruiting
  • Arizona Cardiovascular Research Center
  • HonorHealthRecruiting
  • Comprehensive CardiovascularRecruiting
  • Cardiovascular Consultants Heart CenterRecruiting
  • Marin General Hospital
  • USC University HospitalRecruiting
  • Colorado Heart & Vascular, P.C.
  • Washington Hospital Center
  • Shands at the University of FloridaRecruiting
  • Heart Rhythm SolutionsRecruiting
  • Piedmont Heart Institute
  • Emory University HospitalRecruiting
  • Iowa Heart CenterRecruiting
  • Baptist Health LexingtonRecruiting
  • Tufts Medical Center
  • Sparrow Clinical Research InstituteRecruiting
  • North Mississippi Medical Center
  • Washington University School of MedicineRecruiting
  • Catholic Medical CenterRecruiting
  • Deborah Heart & Lung CenterRecruiting
  • Cardiovascular Associates of the Delaware ValleyRecruiting
  • Lourdes Cardiology ServicesRecruiting
  • New York Presbyterian Brooklyn Methodist HospitalRecruiting
  • Mission Health & Hospitals
  • Cleveland Clinic FoundationRecruiting
  • Ohio State University
  • The Toledo HospitalRecruiting
  • Hightower ClinicalRecruiting
  • University of Pittsburgh Medical CenterRecruiting
  • Medical University of South CarolinaRecruiting
  • Texas Cardiac Arrhythmia
  • CHI St. Luke's Health Baylor College of Medicine Med. Ctr.Recruiting
  • Memorial Katy Cardiology Associates
  • South Texas Cardiovascular Consultants
  • Heart Rhythm AssociatesRecruiting
  • Sentara Norfolk General HospitalRecruiting
  • Warringal Private Hospital
  • Universitätsklinik GrazRecruiting
  • Hopital Erasme
  • Foothills Medical CentreRecruiting
  • St. Paul's HospitalRecruiting
  • Royal Jubilee HospitalRecruiting
  • Hopital du Sacre-Coeur de MontrealRecruiting
  • HSC, Eastern HealthRecruiting
  • QE II Health SciencesRecruiting
  • Kingston General HospitalRecruiting
  • St. Mary's General HospitalRecruiting
  • Cardiac Arrhythmia Research Group Inc. (CARGI)Recruiting
  • St. Michael's HospitalRecruiting
  • Institut de Cardiologie de Montreal (Montreal Heart Inst.)Recruiting
  • McGill University Health Centre General HospitalRecruiting
  • CHUS Fleurimont
  • Royal Alexandra HospitalRecruiting
  • CHUMRecruiting
  • Institut de Cardiologie de Quebec (Hôpital Laval)
  • Tianjin Chest HospitalRecruiting
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
  • Sir Run Run Shaw HospitalRecruiting
  • APEX Foundation
  • Helsinki University Central Hospital (HYKS)Recruiting
  • Centre de Cardiologie du Pays Basque
  • Hopital Henri MondorRecruiting
  • CHR de La Reunion - Site du CHFGRecruiting
  • CHU Rangueil ToulouseRecruiting
  • CHRU Hopital de PontchaillouRecruiting
  • St-Etienne CHURecruiting
  • Klinikum der Ruprecht-Karls-Universität HeidelbergRecruiting
  • Herzzentrum Dresden GmbH Universitätsklinik
  • Kerckhoff-Klinik gGmbHRecruiting
  • Medizinische Hochschule Hannover
  • The University of Hong Kong (Queen Mary Hospital)Recruiting
  • Asian Institute of Gastroenterology (AIG) Hospital
  • Care Institute of Medical SciencesRecruiting
  • Apollo Hospitals, BangaloreRecruiting
  • Narayana Institute of Cardiac Sciences, Bommasandra
  • Medanta - The Medicity HospitalRecruiting
  • Max Super Specialty HospitalRecruiting
  • Mater Dei HospitalRecruiting
  • Azienda Ospedaliera Di VenereRecruiting
  • Azienda Ospedaliera Universitaria MaterDominiRecruiting
  • Azienda Ospedaliera S. G. MoscatiRecruiting
  • Chiba UniversityRecruiting
  • Hyogo College of MedicineRecruiting
  • St. Marianna University School of Medicine HospitalRecruiting
  • Kitasato University HospitalRecruiting
  • Sejong Hospital
  • Keimyung University Dongsan Medical CenterRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Keimyung University Dongsan Medical CenterRecruiting
  • Asan Medical CentreRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Amsterdam Academic Medical Centre (AMC)Recruiting
  • Scanmed SARecruiting
  • Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu
  • Hospital distrital de Santarém, E.P.E.
  • Santa Maria HospitalRecruiting
  • Arrhythmia Group LLCRecruiting
  • Meshalkin National Medical Research Center
  • King Fahad Armed Forces HospitalRecruiting
  • King Faisal Specialist Hospital (KFSH)
  • King Fahad Medical CityRecruiting
  • King Khalid University Hospital
  • Clinical Center of Serbia - Pacemaker CenterRecruiting
  • National Heart Centre Singapore
  • Hospital Universitario Infanta CristinaRecruiting
  • Hospital Clínic de BarcelonaRecruiting
  • Fundación Jiménez DíazRecruiting
  • Hospital Puerta de Hierro - Hospital UniversitarioRecruiting
  • HCU Virgen de la VictoriaRecruiting
  • Hospital Universitario de SalamancaRecruiting
  • Karolinska University Hospital, SolnaRecruiting
  • Basel University Hospital
  • Taichung Veterans General HospitalRecruiting
  • Phramongkutklao HospitalRecruiting
  • Cleveland Clinic Abu Dhabi
  • Southampton University HospitalRecruiting
  • John Radcliffe HospitalRecruiting
  • The Royal Sussex County HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SyncAV Arm

Fixed AV Delay Arm

Arm Description

Treatment Arm

Control Arm

Outcomes

Primary Outcome Measures

Reduction in left ventricular end systolic volume (LVESV) between baseline and 12 months
Reduction of LVESV as a continuous variable from baseline to 12 months compared between subjects in the SyncAV and fixed AV delay arms.

Secondary Outcome Measures

Percentage of CRT Responders at 12 months
Percentage of subjects classified as CRT responders after 12 months of follow-up compared between subjects in the SyncAV and fixed AV delay arms, as measured by LVESV reduction of at least 15% compared to baseline.
Reduction in LVESV in female subjects between baseline and 12 months
Reduction of LVESV as a continuous variable from baseline to 12 months compared between female subjects in the SyncAV and fixed AV delay arms.
Percentage of female subjects classified as CRT Responders at 12 months
Percentage of female subjects classified as CRT responders after 12 months of follow-up compared between female subjects in the SyncAV and fixed AV delay arms, as measured by LVESV reduction of at least 15% compared to baseline.

Full Information

First Posted
September 20, 2019
Last Updated
September 21, 2023
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT04100148
Brief Title
SyncAV Post-Market Trial
Acronym
SyncAV
Official Title
SyncAV Post-Market Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2019 (Actual)
Primary Completion Date
April 25, 2024 (Anticipated)
Study Completion Date
May 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The SyncAV Post-Market Trial is a prospective, randomized, multi-center trial performed to determine if cardiac resynchronization therapy (CRT) devices programmed with SyncAV ON improve long-term CRT response compared to devices programmed with conventional CRT through evaluation of changes in left ventricular (LV) reverse remodeling.
Detailed Description
The SyncAV Post-Market Trial is designed as a prospective, randomized, multi-center trial. The trial will require physicians to implant an Abbott CRT device and Abbott Quadripolar LV lead with any available right atrial and right ventricular leads. Sites will randomize subjects in a 1:1 ratio within 2 - 6 weeks post successful CRT implant: Arm 1 - SyncAV CRT programmed ON; Arm 2 - programmed fixed atrioventricular (AV) delay. For those subjects randomized to SyncAV programmed ON, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF), at biventricular (BiV) pacing nominal settings, with various SyncAV programmed offsets, and at LV first 30 ms, RV first 30 ms and LV-only pacing with optimal SyncAV offsets. The site will then program the subject's device using the SyncAV offset that provided the narrowest QRS duration. For those subjects randomized to the fixed AV delay arm, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF) and at BiV pacing nominal settings. Sites will then program the subject's device using BiV pacing nominal settings. Sites will collect data at baseline (before CRT implant), randomization, and at 3-month, 6-month, and 12-month visits. For subjects randomized to the SyncAV ON arm, sites will optimize the SyncAV feature again at 3 months and 6 months in the same manner as the randomization visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
SyncAV feature, CRT optimization, CRT non-responders, ECG optimization, Cardiac remodeling, CRT with SyncAV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SyncAV Arm
Arm Type
Experimental
Arm Description
Treatment Arm
Arm Title
Fixed AV Delay Arm
Arm Type
Active Comparator
Arm Description
Control Arm
Intervention Type
Device
Intervention Name(s)
SyncAV programmed ON
Intervention Description
For those subjects randomized to SyncAV programmed ON, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF), at BiV pacing nominal settings, with various SyncAV programmed offsets, and at LV first 30 ms, RV first 30 ms and LV-only pacing with optimal SyncAV offsets. The site will then program the subject's device using the SyncAV offset that provided the narrowest QRS duration.
Intervention Type
Device
Intervention Name(s)
Fixed AV delay
Intervention Description
For those subjects randomized to the fixed AV delay arm, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF) and at BiV pacing nominal settings. Sites will then program the subject's device using BiV pacing nominal settings.
Primary Outcome Measure Information:
Title
Reduction in left ventricular end systolic volume (LVESV) between baseline and 12 months
Description
Reduction of LVESV as a continuous variable from baseline to 12 months compared between subjects in the SyncAV and fixed AV delay arms.
Time Frame
12 months following trial randomization
Secondary Outcome Measure Information:
Title
Percentage of CRT Responders at 12 months
Description
Percentage of subjects classified as CRT responders after 12 months of follow-up compared between subjects in the SyncAV and fixed AV delay arms, as measured by LVESV reduction of at least 15% compared to baseline.
Time Frame
12 months following trial randomization
Title
Reduction in LVESV in female subjects between baseline and 12 months
Description
Reduction of LVESV as a continuous variable from baseline to 12 months compared between female subjects in the SyncAV and fixed AV delay arms.
Time Frame
12 months following trial randomization
Title
Percentage of female subjects classified as CRT Responders at 12 months
Description
Percentage of female subjects classified as CRT responders after 12 months of follow-up compared between female subjects in the SyncAV and fixed AV delay arms, as measured by LVESV reduction of at least 15% compared to baseline.
Time Frame
12 months following trial randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled to receive a new CRT implant or an upgrade (Abbott CRT device and Abbott Quadripolar LV lead) from an existing implantable cardioverter defibrillator/pacemaker implant with no more than 10% RV pacing at the last device interrogation, no prior LV lead placement, AND meet the following additional criteria: Mild to severe heart failure despite optimal medical therapy for at least 3 months prior to signing consent. Optimal medical therapy is defined as maximal tolerated dose of beta-blockers and a therapeutic dose of angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, or aldosterone antagonist LVEF ≤ 35% based on a prior standard of care echocardiogram Left bundle branch block (LBBB) as documented on an ECG. Criteria for complete LBBB should include, i. QRS duration ≥ 120 ms ii. QS or rS pattern in leads V1 iii. mid-QRS notching or slurring in leads I, aVL, V5, and V6 iv. Absence of Q-wave in leads V5 and V6 d. Intact AV conduction (PR interval ≤ 280 ms on surface ECG) At least 18 years old, or of legal age and willing and capable to give informed consent specific to each country and national laws Willing and able to comply with the prescribed follow-up tests and schedule of evaluations Exclusion Criteria: Recent myocardial infarction or unstable angina within 40 days prior to signing consent Recent cardiac revascularization (angioplasty, stent or bypass graft) in the 4 weeks prior to signing consent or planned within 3 months following consent Cerebrovascular accident or transient ischemic attack in the 3 months prior to signing consent Any other therapeutic cardiovascular procedure (transcatheter aortic valve replacement, MitraClip, cardiac surgery, left atrial appendage closure, patent foramen ovale closure, or any ablation procedures) in the 3 months prior to signing consent Permanent or persistent AF at the time of signing consent Paroxysmal AF with at least one cardioversion within 60 days prior to signing consent Prior CRT device implant Prior His Bundle pacing implant or plan to have His Bundle pacing implant Pregnant or breastfeeding at the time of signing consent Incapacitated or unable to read or write Undergone cardiac transplantation or have a classification of Status 1 for cardiac transplantation or consideration for transplantation during the study follow-up period Life expectancy < 12 months due to any condition Unavailable for at least 12 months of follow-up visits Enrolled in or intend to participate in a clinical drug and/or device study during this clinical trial which could confound the results of this trial as determined by Abbott
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anuja A Kulkarni, MPH
Phone
408 845 8275
Email
anuja.kulkarni@abbott.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niraj Varma, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Center Research, LLC.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Jennings, MD
Facility Name
Arizona Cardiovascular Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
HonorHealth
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rahul Doshi, MD
Facility Name
Comprehensive Cardiovascular
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viral Mehta, MD
Facility Name
Cardiovascular Consultants Heart Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rohit Sundrani, MD
Facility Name
Marin General Hospital
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Individual Site Status
Withdrawn
Facility Name
USC University Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-5313
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Ho, MD
Facility Name
Colorado Heart & Vascular, P.C.
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Withdrawn
Facility Name
Shands at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Miles, MD
Facility Name
Heart Rhythm Solutions
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33328
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Awais Humayun, MD
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Completed
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anand Shah, MD
Facility Name
Iowa Heart Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dwayne Campbell, MD
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gery Tomassoni, MD
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Withdrawn
Facility Name
Sparrow Clinical Research Institute
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Ip, MD
Facility Name
North Mississippi Medical Center
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Individual Site Status
Withdrawn
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Smith, MD
Facility Name
Catholic Medical Center
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Kim, MD
Facility Name
Deborah Heart & Lung Center
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raffaele Corbisiero, MD
Facility Name
Cardiovascular Associates of the Delaware Valley
City
Haddon Heights
State/Province
New Jersey
ZIP/Postal Code
08035
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Mark, MD
Facility Name
Lourdes Cardiology Services
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darius Sholevar, MD
Facility Name
New York Presbyterian Brooklyn Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Wong, MD
Facility Name
Mission Health & Hospitals
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Individual Site Status
Withdrawn
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Cantillon, MD
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Withdrawn
Facility Name
The Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Phelan, MD
Facility Name
Hightower Clinical
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Summers, MD
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aditya Bhonsale, MD
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Gold, MD
Facility Name
Texas Cardiac Arrhythmia
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Withdrawn
Facility Name
CHI St. Luke's Health Baylor College of Medicine Med. Ctr.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mihail Chelu, MD
Facility Name
Memorial Katy Cardiology Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77094
Country
United States
Individual Site Status
Completed
Facility Name
South Texas Cardiovascular Consultants
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78201
Country
United States
Individual Site Status
Completed
Facility Name
Heart Rhythm Associates
City
Shenandoah
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Strickland, MD
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erich L Kiehl, MD
Facility Name
Warringal Private Hospital
City
Heidelberg
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Universitätsklinik Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Scherr, MD
Facility Name
Hopital Erasme
City
Brussels
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Glen Sumner, MD
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2E8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shanta Chakrabarti, MD
Facility Name
Royal Jubilee Hospital
City
Victoria
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence Sterns, MD
Facility Name
Hopital du Sacre-Coeur de Montreal
City
Montréal
State/Province
Montreal
ZIP/Postal Code
H4J 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuliano Becker, MD
Facility Name
HSC, Eastern Health
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric Paulin, MD
Facility Name
QE II Health Sciences
City
Halifax
State/Province
Nova Scotia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ciorsti Macintyre, MD
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrian Baranchuk, MD
Facility Name
St. Mary's General Hospital
City
Kitchener
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Umjeet Jolly, MD
Facility Name
Cardiac Arrhythmia Research Group Inc. (CARGI)
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1B 4Z8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Derek Yung, MD
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1WB
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iqwal Mangat, MD
Facility Name
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernard Thibault, MD
Facility Name
McGill University Health Centre General Hospital
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vidal Essebag, MD
Facility Name
CHUS Fleurimont
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Completed
Facility Name
Royal Alexandra Hospital
City
Edmonton
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Benoit, MD
Facility Name
CHUM
City
Montreal
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit Coutu, MD
Facility Name
Institut de Cardiologie de Quebec (Hôpital Laval)
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Completed
Facility Name
Tianjin Chest Hospital
City
Tianjin
State/Province
Heping
ZIP/Postal Code
300041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Xu, MD
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaolin Xue, MD
Facility Name
Sir Run Run Shaw Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guosheng Fu, MD
Facility Name
APEX Foundation
City
Medellin
State/Province
Antioq
Country
Colombia
Individual Site Status
Withdrawn
Facility Name
Helsinki University Central Hospital (HYKS)
City
Helsinki
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jarkko Karvonen, MD
Facility Name
Centre de Cardiologie du Pays Basque
City
Bayonne
State/Province
AQT
Country
France
Individual Site Status
Withdrawn
Facility Name
Hopital Henri Mondor
City
Creteil
State/Province
Ile-de-France
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Lellouche, MD
Facility Name
CHR de La Reunion - Site du CHFG
City
Saint-Denis Cedex
State/Province
Ile-de-France
ZIP/Postal Code
97405
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gael Clerici, MD
Facility Name
CHU Rangueil Toulouse
City
Toulouse
State/Province
Midi-Pyrenees
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Mondoly, MD
Facility Name
CHRU Hopital de Pontchaillou
City
Rennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Leclercq, MD
Facility Name
St-Etienne CHU
City
Saint-Priest-En-Jarez
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine Da Costa, MD
Facility Name
Klinikum der Ruprecht-Karls-Universität Heidelberg
City
Heidelberg
State/Province
Bad-wur
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Panagiotis Xynogalos, MD
Facility Name
Herzzentrum Dresden GmbH Universitätsklinik
City
Dresden
State/Province
Saxony
Country
Germany
Individual Site Status
Completed
Facility Name
Kerckhoff-Klinik gGmbH
City
Bad Nauheim
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Hain, MD
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Individual Site Status
Withdrawn
Facility Name
The University of Hong Kong (Queen Mary Hospital)
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hung Fat Tse, MD
Facility Name
Asian Institute of Gastroenterology (AIG) Hospital
City
Hyderabad
State/Province
Andprad
ZIP/Postal Code
500082
Country
India
Individual Site Status
Completed
Facility Name
Care Institute of Medical Sciences
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380060
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ajay Naik, MD
Facility Name
Apollo Hospitals, Bangalore
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560076
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Girish Navasundi, MD
Facility Name
Narayana Institute of Cardiac Sciences, Bommasandra
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560099
Country
India
Individual Site Status
Terminated
Facility Name
Medanta - The Medicity Hospital
City
Gurgaon
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kartikeya Bhargava, MD
Facility Name
Max Super Specialty Hospital
City
New Delhi
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Balbir Singh, MD
Facility Name
Mater Dei Hospital
City
Bari
State/Province
Apulia
ZIP/Postal Code
70125
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Grandinetti, MD
Facility Name
Azienda Ospedaliera Di Venere
City
Carbonara
State/Province
Apulia
ZIP/Postal Code
70131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincenzo Bonfantino, MD
Facility Name
Azienda Ospedaliera Universitaria MaterDomini
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Curcio, MD
Facility Name
Azienda Ospedaliera S. G. Moscati
City
Avellino
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilio Di Lorenzo, MD
Facility Name
Chiba University
City
Chiba-shi
State/Province
Chiba
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yusuke Kondo, MD
Facility Name
Hyogo College of Medicine
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takanao Mine, MD
Facility Name
St. Marianna University School of Medicine Hospital
City
Kawasaki
State/Province
Kanagawa-Ken
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomoo Harada, MD
Facility Name
Kitasato University Hospital
City
Sagamihara
State/Province
Kanagwa
ZIP/Postal Code
252-0375
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junya Ako, MD
Facility Name
Sejong Hospital
City
Bucheon
State/Province
Sudogwn
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
State/Province
Sudogwn
ZIP/Postal Code
42601
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seongwook Han, MD
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Sudogwn
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YoungJin Cho, MD
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seongwook Han, MD
Facility Name
Asan Medical Centre
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minsoo Cho, MD
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo young Joung, MD
Facility Name
Amsterdam Academic Medical Centre (AMC)
City
Amsterdam
State/Province
Noord-h
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reinoud Knops, MD
Facility Name
Scanmed SA
City
Krakow
State/Province
Lesrpld
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerzy Matysek, MD
Facility Name
Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu
City
Poznań
Country
Poland
Individual Site Status
Completed
Facility Name
Hospital distrital de Santarém, E.P.E.
City
Santarém
State/Province
Sntarem
Country
Portugal
Individual Site Status
Withdrawn
Facility Name
Santa Maria Hospital
City
Lisboa
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Marques, MD
Facility Name
Arrhythmia Group LLC
City
Ponce
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Perez Gil, MD
Facility Name
Meshalkin National Medical Research Center
City
Novosibirsk
State/Province
Siberia
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
King Fahad Armed Forces Hospital
City
Jeddah
State/Province
Makkah
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sweidan Raed, MD
Facility Name
King Faisal Specialist Hospital (KFSH)
City
Riyadh
State/Province
Riyadh Province
ZIP/Postal Code
12713
Country
Saudi Arabia
Individual Site Status
Completed
Facility Name
King Fahad Medical City
City
Riyadh
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faisal Al Samadi, MD
Facility Name
King Khalid University Hospital
City
Riyadh
Country
Saudi Arabia
Individual Site Status
Withdrawn
Facility Name
Clinical Center of Serbia - Pacemaker Center
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Goran Milasinovic, MD
Facility Name
National Heart Centre Singapore
City
Singapore
State/Province
Central
Country
Singapore
Individual Site Status
Withdrawn
Facility Name
Hospital Universitario Infanta Cristina
City
Badajoz
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joaquin Fernandez Concha, MD
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lluis Mont, MD
Facility Name
Fundación Jiménez Díaz
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Manuel Rubio Campal, MD
Facility Name
Hospital Puerta de Hierro - Hospital Universitario
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Fernandez-Lozano, MD
Facility Name
HCU Virgen de la Victoria
City
Málaga
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Alzueta Rodriguez, MD
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Jimenez Candil, MD
Facility Name
Karolinska University Hospital, Solna
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecilia Linde, MD
Facility Name
Basel University Hospital
City
Basel
Country
Switzerland
Individual Site Status
Withdrawn
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Long Huang, MD
Facility Name
Phramongkutklao Hospital
City
Bangkok
State/Province
Central Thailand
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thoranis Chantrarat, MD
Facility Name
Cleveland Clinic Abu Dhabi
City
Abu Dhabi
Country
United Arab Emirates
Individual Site Status
Withdrawn
Facility Name
Southampton University Hospital
City
Southampton
State/Province
Soeast
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Flett, MD
Facility Name
John Radcliffe Hospital
City
Oxford
State/Province
South East England
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tim Betts, MD
Facility Name
The Royal Sussex County Hospital
City
Brighton
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Coombs, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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