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Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator (TEMPO)

Primary Purpose

Ventricular Arrhythmia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Eleclazine
Placebo to match eleclazine
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Arrhythmia focused on measuring VT, VF, Ventricular Tachycardia, Ventricular Fibrillation, shock, ATP

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Have an ICD or CRT-D implanted for primary or secondary prevention and at least one ICD intervention for ventricular tachycardia/ventricular fibrillation (VT/VF) [shock or ATP] within 60 days prior to screening or a documented VT/VF episode (prior to implantation) within 60 days prior to screening
  • Use of highly effective contraception methods if female of childbearing potential or sexually active male
  • Must be hemodynamically stable

Key Exclusion Criteria:

  • New York Heart Association (NYHA) Class IV heart failure
  • Myocardial infarction, unstable angina, coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) within 4 weeks prior to screening or during the screening period before randomization
  • Hemodynamically significant primary obstructive valvular disease
  • History of congenital heart disease
  • Inherited arrhythmia such as Brugada syndrome. Individuals with long QT syndrome Type 3 (LQT-3) or hypertrophic cardiomyopathy (HCM) may be considered.
  • Individuals who are being considered for cardiac transplantation and are on a cardiac transplant list
  • History of seizures or epilepsy
  • Cardiac ablation within 3 months prior to screening or planned cardiac ablation during the study
  • Severe renal impairment
  • Abnormal liver function tests
  • Currently taking Class I and Class III antiarrhythmic drugs; such medications should be discontinued 5 half-lives (or 28 days for chronic use of amiodarone) prior to randomization
  • Currently taking drugs or products that are strong inhibitors or inducers of CYP3A; such medications should be discontinued 5 half-lives prior to randomization
  • Currently taking ranolazine; ranolazine should be discontinued at least 7 days prior to randomization
  • Females who are pregnant or are breastfeeding
  • Individuals with a subcutaneous ICD
  • Body mass index (BMI) ≥ 36 kg/m^2

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Sites / Locations

  • Cardiovascular Associates of Mesa
  • Long Beach Memorial Hospital
  • Good Samaritan Hospital
  • Radin Cardiovascular Medical Associates
  • Regional Cardiology Associates
  • South Denver Cardiology Associates, PC
  • Atlantic Clinical Research Collaborative
  • Clearwater Cardiovascular and Interventional Consultants
  • Coastal Cardiology Consultants PA dba Heart and Vascular Institute of Florida
  • The Heart Institute at Largo
  • Charlotte Heart and Vascular Institute
  • Florida Medical Clinic PA
  • Athens Regional Specialty Services
  • Washington Adventist Hospital
  • Mid Michigan Medical Center - Midland
  • Michigan Cardiovascular Institute
  • Great Falls Clinic
  • Methodist Physicians Clinic Heart Consultants
  • New Mexico Hear Institute
  • New York Methodist Hospital
  • Durham VA Medical Center
  • Aultman Hospital
  • Ohiohealth Corporation
  • Capital Area Research
  • CardioVascular Institute
  • Care New England Health Care, Kent Hospital
  • Medical University of South Carolina
  • Volunteer Research Group
  • Seton Heart Institute
  • Cardiovascular Research Institute of Dallas
  • West Houston Area Clinical Trial Consultants
  • The University of Vermont Medical Center
  • Inova Fairfax Hospital
  • Virginia Heart Group Ltd
  • Stroobants Cardiovascular Center
  • Carilion Roanoke Memorial Hospital
  • Marshfield Clinic Research Foundation
  • Kingston General Hospital
  • Chum Hotel Dieu
  • Centre Hospitalier Universitaire de Sherbrooke CHUS
  • QEII Health Sciences Centre
  • Fakultni nemocnice Olomouc
  • Charles University Hospital Královské Vinohrady
  • Aalborg University Hospital
  • Rigshospitalet, The Heart Center
  • Gentofte Hospitak, Deparment of Cardiology
  • Odense University Hospital/Department of Cardiology
  • Vivantes Humboldt Klinikum
  • University Medical Center Goettingen
  • University of Heidelberg
  • Medizinische Klinik und Poliklinik I Abteilung für Kardiologie
  • Klinikum der Universität Regensburg
  • Gemeinschaftspraxis für Innere Medizin
  • State Hospital for Cardiology
  • Budai Irgalmasrendi Kórház
  • Semmelweis Egyetem
  • Magyar Honvedseg Egeszsegugyi Kozpont
  • Zala Megyei Kórház
  • HaEmek Medical Center
  • Rambam Health Care Campus
  • Tel Aviv University/Meir Medical Center
  • Shaare Zedek Medical Center
  • Hadassah Medical Center
  • Galilee Medical Center
  • Sheba Medical Center
  • Kaplan Medical Center
  • Tel Aviv Sourasky Medical Center
  • Onze Lieve Vrouwe Gasthuis
  • Amphia ziekenhuis
  • Catharina ziekenhuis
  • Maastricht University Medical Center
  • St.Antonius Hospital
  • Isala
  • Samodzielny Publiczny Szpital Kliniczny nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach Górnosla
  • Collegium Medicum Uniwersytetu Jagiellonskiego
  • Medical University of Lodz
  • Mc Tronik Specjalistyczny Gabinet Kontroli Stymulatorow Serca Dr N. Med. Michal Chudzik
  • Indywidualna Specjalistyczna Praktyka Lekarska Andrzej Lubinski
  • NZOZ Sopockie Centrum badan Kardiolog.ProCordis pawel Miekus
  • Indywidualna Specjalistyczna Praktyka Lekarska Jarosław Kaźmierczak
  • Instytut Kardiologii im Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego
  • Szpital Wolski im Dr Anny Gostynskiej SP ZOZ
  • Warszawski Uniwersytet Medyczny
  • Medical University Wroclaw

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Eleclazine 3 mg

Eleclazine 6 mg

Placebo

Arm Description

Participants will receive a single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 3 mg daily as maintenance for up to approximately 20 months.

Participants will receive a single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 6 mg daily as maintenance for up to approximately 20 months.

Participants will receive a single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months.

Outcomes

Primary Outcome Measures

Overall Occurrence (Total Number) of Appropriate Implantable Cardioverter-Defibrillator Device (ICD) Interventions (Anti-Tachycardia Pacing or Shock) Through Week 24

Secondary Outcome Measures

Overall Occurrence (Total Number) of Appropriate ICD Interventions (ATP or Shock) Through End of Study
Change From Baseline in Premature Ventricular Complex (PVC) Count as Assessed by Continuous Electrocardiogram (cECG) Monitoring
PVC count per 48 hours was obtained from cECG readings at Baseline and Week 12. Change in PVC from baseline was measured in units of number of episodes/48 hours. Change from baseline was calculated as the value at Week 12 minus the value at Baseline.
Change From Baseline in Nonsustained Ventricular Tachycardia (nsVT) Count as Assessed by Continuous cECG Monitoring
The count of nsVTs per 48 hours was obtained from cECG readings at Baseline and Week 12. Change in nsVT from baseline was measured in units of number of episodes/48 hours. Change from baseline was calculated as the value at Week 12 minus the value at Baseline.
Overall Occurrence (Total Number) of Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) (Treated or Untreated) Through Week 24 and End of Study
Overall Occurrence (Total Number) of Electrical Storm Through Week 24 and End of Study
An electrical storm was defined as ≥ 3 separate episodes of ventricular arrhythmia within a 24-hour period terminated by ICD.
Overall Occurrence (Total Number) of Inappropriate ICD Interventions Through Week 24 and End of Study
Change in Left Ventricular Systolic and Diastolic Function as Assessed by Left Ventricular Ejection Fraction (LVEF)
LVEF is a measure of how much blood is pumped out of the left ventricle of the heart. Change from baseline was calculated as the value at Week 12 or 24 minus the value at Baseline.
Time From First Dose of Study Drug to the First Occurrence of Appropriate ICD Interventions (ATP or Shock) or Cardiovascular (CV) Death
CV deaths were determined through the adjudication by an external independent clinical event committee (CEC). The deaths that were adjudicated as undetermined were considered cardiovascular related. For each participant, the time from the first dose of study drug to the beginning of the earliest appropriate ICD intervention through the last day on study or, in absence of appropriate ICD interventions, to a CV death was derived as (first event date - first dose date + 1). The participants without appropriate ICD interventions or CV death were censored at the last day on study. As planned, data was reported only for Cohort 2 and combined Cohorts 1 and 2. Time to first occurrence of an appropriate ICD interventions or CV death was analyzed using Kaplan-Meier (KM) estimates.
Time From First Dose of Study Drug to the First Occurrence of CV Hospitalization, Emergency Room (ER) Visit, or CV Death
CV hospitalizations, CV ER visits, and CV deaths were determined through the adjudication by the CEC. The events that were adjudicated as undetermined were considered cardiovascular related. For each participant, the time from the first dose of study drug to the first CV hospitalization or CV ER visit through the last day on study or, in absence of CV hospitalizations or CV ER visits, to a CV death were derived as (first event date - first dose date + 1). The participants without CV hospitalizations, CV ER visits, or CV death were censored at the last day on study. As planned, data was reported only for Cohort 2 and combined Cohorts 1 and 2. Time to first occurrence of CV hospitalization, ER visit, or CV death was analyzed using KM estimates.

Full Information

First Posted
April 2, 2014
Last Updated
March 19, 2019
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02104583
Brief Title
Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator
Acronym
TEMPO
Official Title
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose Ranging, Parallel Group Study to Evaluate the Effect of GS-6615 on Ventricular Arrhythmia in Subjects With Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the effect of eleclazine (GS-6615) compared to placebo on the overall occurrence of appropriate implantable cardioverter-defibrillator (ICD) interventions (antitachycardia pacing [ATP] or shock) in adults with ICD or cardiac resynchronization therapy-defibrillator (CRT-D).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Arrhythmia
Keywords
VT, VF, Ventricular Tachycardia, Ventricular Fibrillation, shock, ATP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
313 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eleclazine 3 mg
Arm Type
Experimental
Arm Description
Participants will receive a single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 3 mg daily as maintenance for up to approximately 20 months.
Arm Title
Eleclazine 6 mg
Arm Type
Experimental
Arm Description
Participants will receive a single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 6 mg daily as maintenance for up to approximately 20 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months.
Intervention Type
Drug
Intervention Name(s)
Eleclazine
Other Intervention Name(s)
GS-6615
Intervention Description
Eleclazine tablets administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo to match eleclazine
Intervention Description
Placebo to match eleclazine tablets administered orally
Primary Outcome Measure Information:
Title
Overall Occurrence (Total Number) of Appropriate Implantable Cardioverter-Defibrillator Device (ICD) Interventions (Anti-Tachycardia Pacing or Shock) Through Week 24
Time Frame
Randomization up to 24 weeks
Secondary Outcome Measure Information:
Title
Overall Occurrence (Total Number) of Appropriate ICD Interventions (ATP or Shock) Through End of Study
Time Frame
Randomization up to 22 months
Title
Change From Baseline in Premature Ventricular Complex (PVC) Count as Assessed by Continuous Electrocardiogram (cECG) Monitoring
Description
PVC count per 48 hours was obtained from cECG readings at Baseline and Week 12. Change in PVC from baseline was measured in units of number of episodes/48 hours. Change from baseline was calculated as the value at Week 12 minus the value at Baseline.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Nonsustained Ventricular Tachycardia (nsVT) Count as Assessed by Continuous cECG Monitoring
Description
The count of nsVTs per 48 hours was obtained from cECG readings at Baseline and Week 12. Change in nsVT from baseline was measured in units of number of episodes/48 hours. Change from baseline was calculated as the value at Week 12 minus the value at Baseline.
Time Frame
Baseline to Week 12
Title
Overall Occurrence (Total Number) of Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) (Treated or Untreated) Through Week 24 and End of Study
Time Frame
Randomization up to Week 24; Randomization up to end of study (up to 22 months)
Title
Overall Occurrence (Total Number) of Electrical Storm Through Week 24 and End of Study
Description
An electrical storm was defined as ≥ 3 separate episodes of ventricular arrhythmia within a 24-hour period terminated by ICD.
Time Frame
Randomization up to Week 24; Randomization up to end of study (up to 22 months)
Title
Overall Occurrence (Total Number) of Inappropriate ICD Interventions Through Week 24 and End of Study
Time Frame
Randomization up to Week 24; Randomization up to end of study (up to 22 months)
Title
Change in Left Ventricular Systolic and Diastolic Function as Assessed by Left Ventricular Ejection Fraction (LVEF)
Description
LVEF is a measure of how much blood is pumped out of the left ventricle of the heart. Change from baseline was calculated as the value at Week 12 or 24 minus the value at Baseline.
Time Frame
Baseline to Week 12; Baseline to Week 24
Title
Time From First Dose of Study Drug to the First Occurrence of Appropriate ICD Interventions (ATP or Shock) or Cardiovascular (CV) Death
Description
CV deaths were determined through the adjudication by an external independent clinical event committee (CEC). The deaths that were adjudicated as undetermined were considered cardiovascular related. For each participant, the time from the first dose of study drug to the beginning of the earliest appropriate ICD intervention through the last day on study or, in absence of appropriate ICD interventions, to a CV death was derived as (first event date - first dose date + 1). The participants without appropriate ICD interventions or CV death were censored at the last day on study. As planned, data was reported only for Cohort 2 and combined Cohorts 1 and 2. Time to first occurrence of an appropriate ICD interventions or CV death was analyzed using Kaplan-Meier (KM) estimates.
Time Frame
From first dose of study drug up to 22 months
Title
Time From First Dose of Study Drug to the First Occurrence of CV Hospitalization, Emergency Room (ER) Visit, or CV Death
Description
CV hospitalizations, CV ER visits, and CV deaths were determined through the adjudication by the CEC. The events that were adjudicated as undetermined were considered cardiovascular related. For each participant, the time from the first dose of study drug to the first CV hospitalization or CV ER visit through the last day on study or, in absence of CV hospitalizations or CV ER visits, to a CV death were derived as (first event date - first dose date + 1). The participants without CV hospitalizations, CV ER visits, or CV death were censored at the last day on study. As planned, data was reported only for Cohort 2 and combined Cohorts 1 and 2. Time to first occurrence of CV hospitalization, ER visit, or CV death was analyzed using KM estimates.
Time Frame
From first dose of study drug up to 22 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Have an ICD or CRT-D implanted for primary or secondary prevention and at least one ICD intervention for ventricular tachycardia/ventricular fibrillation (VT/VF) [shock or ATP] within 60 days prior to screening or a documented VT/VF episode (prior to implantation) within 60 days prior to screening Use of highly effective contraception methods if female of childbearing potential or sexually active male Must be hemodynamically stable Key Exclusion Criteria: New York Heart Association (NYHA) Class IV heart failure Myocardial infarction, unstable angina, coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) within 4 weeks prior to screening or during the screening period before randomization Hemodynamically significant primary obstructive valvular disease History of congenital heart disease Inherited arrhythmia such as Brugada syndrome. Individuals with long QT syndrome Type 3 (LQT-3) or hypertrophic cardiomyopathy (HCM) may be considered. Individuals who are being considered for cardiac transplantation and are on a cardiac transplant list History of seizures or epilepsy Cardiac ablation within 3 months prior to screening or planned cardiac ablation during the study Severe renal impairment Abnormal liver function tests Currently taking Class I and Class III antiarrhythmic drugs; such medications should be discontinued 5 half-lives (or 28 days for chronic use of amiodarone) prior to randomization Currently taking drugs or products that are strong inhibitors or inducers of CYP3A; such medications should be discontinued 5 half-lives prior to randomization Currently taking ranolazine; ranolazine should be discontinued at least 7 days prior to randomization Females who are pregnant or are breastfeeding Individuals with a subcutaneous ICD Body mass index (BMI) ≥ 36 kg/m^2 Note: Other protocol defined Inclusion/Exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Cardiovascular Associates of Mesa
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Long Beach Memorial Hospital
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Good Samaritan Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Radin Cardiovascular Medical Associates
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Regional Cardiology Associates
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
South Denver Cardiology Associates, PC
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Atlantic Clinical Research Collaborative
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Clearwater Cardiovascular and Interventional Consultants
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Coastal Cardiology Consultants PA dba Heart and Vascular Institute of Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
The Heart Institute at Largo
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Charlotte Heart and Vascular Institute
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Florida Medical Clinic PA
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Athens Regional Specialty Services
City
Athens
State/Province
Georgia
ZIP/Postal Code
30606
Country
United States
Facility Name
Washington Adventist Hospital
City
Takoma Park
State/Province
Maryland
ZIP/Postal Code
20912
Country
United States
Facility Name
Mid Michigan Medical Center - Midland
City
Midland
State/Province
Michigan
ZIP/Postal Code
48670
Country
United States
Facility Name
Michigan Cardiovascular Institute
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Methodist Physicians Clinic Heart Consultants
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
New Mexico Hear Institute
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Durham VA Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44708
Country
United States
Facility Name
Ohiohealth Corporation
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Capital Area Research
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
CardioVascular Institute
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Care New England Health Care, Kent Hospital
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Volunteer Research Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Seton Heart Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Cardiovascular Research Institute of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
West Houston Area Clinical Trial Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77094
Country
United States
Facility Name
The University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Virginia Heart Group Ltd
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Stroobants Cardiovascular Center
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Carilion Roanoke Memorial Hospital
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Marshfield Clinic Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Chum Hotel Dieu
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke CHUS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
QEII Health Sciences Centre
City
Halifax
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
Country
Czechia
Facility Name
Charles University Hospital Královské Vinohrady
City
Prague
Country
Czechia
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Rigshospitalet, The Heart Center
City
Copenhagen
Country
Denmark
Facility Name
Gentofte Hospitak, Deparment of Cardiology
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Odense University Hospital/Department of Cardiology
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Vivantes Humboldt Klinikum
City
Berlin
ZIP/Postal Code
13585
Country
Germany
Facility Name
University Medical Center Goettingen
City
Goettingen
Country
Germany
Facility Name
University of Heidelberg
City
Heidelberg
ZIP/Postal Code
'69120
Country
Germany
Facility Name
Medizinische Klinik und Poliklinik I Abteilung für Kardiologie
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinikum der Universität Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Gemeinschaftspraxis für Innere Medizin
City
Riesa
ZIP/Postal Code
1587
Country
Germany
Facility Name
State Hospital for Cardiology
City
Balatonfüred
ZIP/Postal Code
8231
Country
Hungary
Facility Name
Budai Irgalmasrendi Kórház
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Zala Megyei Kórház
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
HaEmek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Tel Aviv University/Meir Medical Center
City
Israel
ZIP/Postal Code
44299
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Galilee Medical Center
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
Country
Netherlands
Facility Name
Amphia ziekenhuis
City
Breda
Country
Netherlands
Facility Name
Catharina ziekenhuis
City
Eindhoven
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands
Facility Name
St.Antonius Hospital
City
Nieuwegein
ZIP/Postal Code
3430EM
Country
Netherlands
Facility Name
Isala
City
Zwolle
Country
Netherlands
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach Górnosla
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
Facility Name
Collegium Medicum Uniwersytetu Jagiellonskiego
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Medical University of Lodz
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
Facility Name
Mc Tronik Specjalistyczny Gabinet Kontroli Stymulatorow Serca Dr N. Med. Michal Chudzik
City
Lódz
ZIP/Postal Code
90-553
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska Andrzej Lubinski
City
Lódz
ZIP/Postal Code
91-078
Country
Poland
Facility Name
NZOZ Sopockie Centrum badan Kardiolog.ProCordis pawel Miekus
City
Sopot
ZIP/Postal Code
81-717
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska Jarosław Kaźmierczak
City
Szczecin
ZIP/Postal Code
70-203
Country
Poland
Facility Name
Instytut Kardiologii im Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego
City
Warsaw
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Szpital Wolski im Dr Anny Gostynskiej SP ZOZ
City
Warszawa
ZIP/Postal Code
01-211
Country
Poland
Facility Name
Warszawski Uniwersytet Medyczny
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Medical University Wroclaw
City
Wroclaw
Country
Poland

12. IPD Sharing Statement

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Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator

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