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Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP (APPRAISE ATP)

Primary Purpose

Sudden Cardiac Death

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Arm 1 (ATP+Shock)
Arm 2 (shock only)
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sudden Cardiac Death focused on measuring Antitachycardia Pacing Therapy, Shock Therapy, Primary Prevention

Eligibility Criteria

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

  • Subject with a Boston Scientific transvenous ICD (de novo implant or upgrade from pacemaker to ICD ) implanted because of one of the following:

    • Prior MI and left ventricular ejection fraction (LVEF) less than or equal to (≤ )30% OR
    • Ischemic or non-ischemic cardiomyopathy, and LVEF ≤ 35% , and a New York Heart Association (NYHA) class II or III
  • Subject is age 21or above, or is considered of legal age per given geography
  • Subject is willing and capable of providing informed consent
  • Subject is willing and capable of complying with follow-up visits as defined by this protocol

Exclusion Criteria:

  • History of spontaneous sustained Ventricular Tachycardia (VT) (≥ 160 bpm at ≥ 30 seconds in duration) or Ventricular Fibrillation (VF) not due to a reversible cause
  • NYHA Class IV documented in the medical records within 90 calendar days prior to enrollment
  • Subject is eligible and scheduled for cardiac resynchronization (CRT) implant
  • Subjects with a previous subcutaneous ICD (S-ICD)
  • Subject with existing TV-ICD device implanted for greater than 60 days
  • Subjects with coronary artery bypass graft surgery or percutaneous coronary intervention within the past 90 calendar days prior to enrollment
  • Subjects with documented myocardial infarction within the past 90 calendar days prior to enrollment
  • Subjects on the active heart transplant list
  • Subject who has a ventricular assist device (VAD) or is to receive a VAD
  • Life expectancy shorter than 18 months due to any medical condition (e.g., cancer, uremia, liver failure, etc…)
  • Subjects currently requiring hemodialysis
  • Subject who is known to pregnant or plans to become pregnant over the course of the trial
  • 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

Sites / Locations

  • Heart Center Research, LLC
  • Providence Alaska Medical Center
  • Tri-City Cardiology
  • Cardiovascular Consultants, LTD
  • Yuma Regional Medical Center
  • Arrhythmia Research Group
  • Mercy Clinic Cardiology
  • Comprehensive Cardiovascular Specialists
  • Scripps Mercy Chula Vista
  • VA Loma Linda
  • Cardiovascular Consultants Medical Group
  • Sharp Memorial Hospital
  • South Denver Cardiology Associates PC
  • Cardiac Specialists
  • Stamford Hospital
  • Christiana Hospital
  • Bradenton Cardiology
  • The Cardiac and Vascular Institute Research Foundation
  • St Vincent's Medical Center
  • Heart of the Villages
  • Watson Clinic Center for Research, Inc
  • Charlotte Heart & Vascular
  • Brevard Cardiovascular Research Associates, Inc
  • Tallahassee Memorial Hospital
  • AdventHeatlh Tampa
  • CorVita Science Foundation
  • Adventist Hinsdale Hospital
  • Alexian Brothers Medical Center
  • Lutheran Medical Group
  • Ball Memorial Hospital
  • University of Iowa Hospitals and Clinics
  • Mercy Hospital Medical Center
  • Overland Park Regional Medical Center
  • Baptist Health Lexington
  • Louisiana State University
  • Union Memorial Hospital
  • Johns Hopkins Hospital
  • Richard A. Henson Research Institute of Peninsula Regional Medical Center
  • Lahey Clinic Hospital
  • Southcoast Physicians Group
  • Mass Heart and Rhythm
  • University of Massachusetts Memorial Medical Center
  • Henry Ford Hospital
  • Cardiology Consultants of East Michigan
  • Western Michigan University - Homer Stryker M.D. School of Medicine
  • Great Lakes Heart & Vascular Institute
  • Munson Medical Center
  • Metro Health Hospital
  • St. Joseph Mercy Hospital
  • St. Luke's Hospital of Duluth
  • Heart and Vascular Hattiesburg Clinic
  • Cox Health
  • The Nebraska Medical Center
  • Dartmouth-Hitchcock Medical Center
  • Cardiovascular Associates of the Delaware Valley.
  • Jersey Shore University Medical Center
  • St. Joseph's Region Medical Center
  • Weill Cornell Medical University
  • Memorial Mission Hospital
  • Duke University Medical Center
  • Wake Forest University School of Medicine
  • Cleveland Clinic Foundation
  • Kettering Medical Center
  • Regional Cardiac Arrhythmia, Inc
  • Mount Carmel Columbus Cardiology Consultants
  • Lehigh Valley Hospital Pocono
  • Bryn Mawr Medical Specialists
  • The Arrhythmia Institute
  • Presbyterian University of Pennsylvania Medical Center
  • Temple University Hospital
  • Trident Medical Center
  • McLeod Cardiology Associates
  • Lexington Medical Center
  • Monument Health Rapid City Hospital, Inc.
  • VA North Texas Health Care System in Dallas
  • Apex Trials Group, LLC
  • University of Texas Houston Health Science Center
  • Heart Institute of East Texas
  • Mission Research Institute
  • McKay Dee Cardiology
  • University of Utah Hospitals and Clinics
  • VA Salt Lake City Health System
  • Bon Secours Heart & Vascular Institute
  • Sentara Norfolk General Hospital
  • Virginia Cardiovascular Specialist
  • Providence Regional Medical Centre Everett
  • PeaceHealth Southwest Medical
  • Charleston Area Medical Center
  • Bellin Health
  • Kepler Universitaetsklinikum GmbH
  • Klinikum Wels-Grieskirchen GmbH
  • Royal Alexandra Hospital
  • Royal Columbian Hospital
  • Victoria Cardiac Arrhythmia Trials, Inc.
  • Hamilton General Hospital
  • Scarborough Health Network-Centenary Site
  • Centre Hospitalier de l'Universite de Montreal
  • Institut de Cardiologie de Montreal
  • Institut universitaire de Cardiologie et de Pneumologie de Quebec.
  • Policlinico di Modena
  • Osp. Civile S. Maria Delle Grazie
  • Presidio Ospedale San Giovanni Bosco
  • Hospital Buon Consiglio
  • Ospedale dei Pellegrini
  • Az. Osp. S. Andrea
  • Chiba University Hospital
  • Kokura Memorial Hospital
  • Kitasato University Hospital
  • Kumamoto University Hospital
  • Kyoto University Hospital
  • Tachikawa General Hospital
  • Niigata University Medical and Dental Hospital
  • National Crebral and Cardiovascular Center Hospital
  • Saitama Medical University International Medical Cnter
  • Chonnam National University
  • Samsung Medical Center
  • Sejong General Hospital
  • Seoul National University Bundang Hospital
  • Pusan National University Yangsan Hospital
  • Severance Hospital, Yonsei University Health System
  • Inje University Busan Paik Hospital
  • Keimyung University Dongsan Medical Center
  • Kyungpook National University Hospital
  • Korea University Anam Hospital
  • Seoul National University Hospital
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Hospital Clínic de Barcelona
  • Hospital La Paz
  • Hospital Donostia
  • Royal Bournemouth Hospital
  • Royal Stoke University Hospital
  • Liverpool Heart and Chest - LHCH
  • St. Bartholomew's Hospital
  • King's College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ATP and Shock

Shock only

Arm Description

Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy.

Once tachycardia has been detected and duration met, this group would receive shock therapy only.

Outcomes

Primary Outcome Measures

Time-to-First All-Cause Shock
Minimum follow up is 18 months and follow up lasts until last patient has completed the 18 month follow up

Secondary Outcome Measures

• All-cause mortality
Time to first appropriate shock
Time to first inappropriate shock

Full Information

First Posted
October 3, 2016
Last Updated
October 3, 2023
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02923726
Brief Title
Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
Acronym
APPRAISE ATP
Official Title
Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP (APPRAISE ATP)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 30, 2016 (Actual)
Primary Completion Date
July 6, 2023 (Actual)
Study Completion Date
July 6, 2023 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective is to understand the role of antitachycardia pacing (ATP) in primary prevention patients indicated for ICD therapy and programmed according to current guidance of higher rate cut-offs and therapy delays. The time to first all-cause shock will be tested in subjects with standard therapy (ATP and shocks) compared to subjects programmed to shock only to assess equivalency.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Cardiac Death
Keywords
Antitachycardia Pacing Therapy, Shock Therapy, Primary Prevention

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ATP and Shock
Arm Type
Active Comparator
Arm Description
Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy.
Arm Title
Shock only
Arm Type
Experimental
Arm Description
Once tachycardia has been detected and duration met, this group would receive shock therapy only.
Intervention Type
Device
Intervention Name(s)
Arm 1 (ATP+Shock)
Intervention Description
Subjects will be randomized and device programmed to the respective arm.
Intervention Type
Device
Intervention Name(s)
Arm 2 (shock only)
Intervention Description
Subjects will be randomized and device programmed to the respective arm.
Primary Outcome Measure Information:
Title
Time-to-First All-Cause Shock
Description
Minimum follow up is 18 months and follow up lasts until last patient has completed the 18 month follow up
Time Frame
From 60 days post implant up to five years
Secondary Outcome Measure Information:
Title
• All-cause mortality
Time Frame
From 60 days post implant up to five years
Title
Time to first appropriate shock
Time Frame
From 60 days post implant up to five years
Title
Time to first inappropriate shock
Time Frame
From 60 days post implant up to five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Subject with a Boston Scientific transvenous ICD (de novo implant or upgrade from pacemaker to ICD ) implanted because of one of the following: Prior MI and left ventricular ejection fraction (LVEF) less than or equal to (≤ )30% OR Ischemic or non-ischemic cardiomyopathy, and LVEF ≤ 35% , and a New York Heart Association (NYHA) class II or III Subject is age 21or above, or is considered of legal age per given geography Subject is willing and capable of providing informed consent Subject is willing and capable of complying with follow-up visits as defined by this protocol Exclusion Criteria: History of spontaneous sustained Ventricular Tachycardia (VT) (≥ 160 bpm at ≥ 30 seconds in duration) or Ventricular Fibrillation (VF) not due to a reversible cause NYHA Class IV documented in the medical records within 90 calendar days prior to enrollment Subject is eligible and scheduled for cardiac resynchronization (CRT) implant Subjects with a previous subcutaneous ICD (S-ICD) Subject with existing TV-ICD device implanted for greater than 60 days Subjects with coronary artery bypass graft surgery or percutaneous coronary intervention within the past 90 calendar days prior to enrollment Subjects with documented myocardial infarction within the past 90 calendar days prior to enrollment Subjects on the active heart transplant list Subject who has a ventricular assist device (VAD) or is to receive a VAD Life expectancy shorter than 18 months due to any medical condition (e.g., cancer, uremia, liver failure, etc…) Subjects currently requiring hemodialysis Subject who is known to pregnant or plans to become pregnant over the course of the trial 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Schuger, M.D.
Organizational Affiliation
University of Rochester Clincal Cardiovascular Research Center
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
Facility Name
Providence Alaska Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Tri-City Cardiology
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Cardiovascular Consultants, LTD
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Yuma Regional Medical Center
City
Yuma
State/Province
Arizona
ZIP/Postal Code
85364
Country
United States
Facility Name
Arrhythmia Research Group
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Mercy Clinic Cardiology
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Comprehensive Cardiovascular Specialists
City
Alhambra
State/Province
California
ZIP/Postal Code
91801
Country
United States
Facility Name
Scripps Mercy Chula Vista
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
VA Loma Linda
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
Facility Name
Cardiovascular Consultants Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
South Denver Cardiology Associates PC
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Cardiac Specialists
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Stamford Hospital
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19805
Country
United States
Facility Name
Bradenton Cardiology
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
The Cardiac and Vascular Institute Research Foundation
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
St Vincent's Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Heart of the Villages
City
Lady Lake
State/Province
Florida
ZIP/Postal Code
32159
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
Charlotte Heart & Vascular
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Brevard Cardiovascular Research Associates, Inc
City
Rockledge
State/Province
Florida
ZIP/Postal Code
32955
Country
United States
Facility Name
Tallahassee Memorial Hospital
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
AdventHeatlh Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33624
Country
United States
Facility Name
CorVita Science Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60605
Country
United States
Facility Name
Adventist Hinsdale Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Alexian Brothers Medical Center
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Lutheran Medical Group
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Ball Memorial Hospital
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Mercy Hospital Medical Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Overland Park Regional Medical Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Louisiana State University
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Union Memorial Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Richard A. Henson Research Institute of Peninsula Regional Medical Center
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21804
Country
United States
Facility Name
Lahey Clinic Hospital
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Southcoast Physicians Group
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Mass Heart and Rhythm
City
Leominster
State/Province
Massachusetts
ZIP/Postal Code
01453
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Cardiology Consultants of East Michigan
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Western Michigan University - Homer Stryker M.D. School of Medicine
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Great Lakes Heart & Vascular Institute
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Metro Health Hospital
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
St. Joseph Mercy Hospital
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
St. Luke's Hospital of Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Heart and Vascular Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Cox Health
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
The Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
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
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
St. Joseph's Region Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
Weill Cornell Medical University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Memorial Mission Hospital
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Regional Cardiac Arrhythmia, Inc
City
Steubenville
State/Province
Ohio
ZIP/Postal Code
43952
Country
United States
Facility Name
Mount Carmel Columbus Cardiology Consultants
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43801
Country
United States
Facility Name
Lehigh Valley Hospital Pocono
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Bryn Mawr Medical Specialists
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
The Arrhythmia Institute
City
Newtown
State/Province
Pennsylvania
ZIP/Postal Code
18940
Country
United States
Facility Name
Presbyterian University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Trident Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
McLeod Cardiology Associates
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29506
Country
United States
Facility Name
Lexington Medical Center
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Monument Health Rapid City Hospital, Inc.
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
VA North Texas Health Care System in Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Apex Trials Group, LLC
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
University of Texas Houston Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Heart Institute of East Texas
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904
Country
United States
Facility Name
Mission Research Institute
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
McKay Dee Cardiology
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
University of Utah Hospitals and Clinics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
VA Salt Lake City Health System
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Facility Name
Bon Secours Heart & Vascular Institute
City
Mechanicsville
State/Province
Virginia
ZIP/Postal Code
23116
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Virginia Cardiovascular Specialist
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Providence Regional Medical Centre Everett
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
PeaceHealth Southwest Medical
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Charleston Area Medical Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Bellin Health
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54305
Country
United States
Facility Name
Kepler Universitaetsklinikum GmbH
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
Klinikum Wels-Grieskirchen GmbH
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W4
Country
Canada
Facility Name
Victoria Cardiac Arrhythmia Trials, Inc.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 1Z4
Country
Canada
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Scarborough Health Network-Centenary Site
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1B 4Z8
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Institut de Cardiologie de Montreal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Institut universitaire de Cardiologie et de Pneumologie de Quebec.
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Policlinico di Modena
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41124
Country
Italy
Facility Name
Osp. Civile S. Maria Delle Grazie
City
Pozzuoli
State/Province
Southern Cluster
ZIP/Postal Code
80018
Country
Italy
Facility Name
Presidio Ospedale San Giovanni Bosco
City
Napoli
ZIP/Postal Code
80100
Country
Italy
Facility Name
Hospital Buon Consiglio
City
Napoli
ZIP/Postal Code
80123
Country
Italy
Facility Name
Ospedale dei Pellegrini
City
Napoli
ZIP/Postal Code
8133
Country
Italy
Facility Name
Az. Osp. S. Andrea
City
Rome
ZIP/Postal Code
00189
Country
Italy
Facility Name
Chiba University Hospital
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Kokura Memorial Hospital
City
Kitakyushu-Shi
State/Province
Fukuoka
ZIP/Postal Code
802-8555
Country
Japan
Facility Name
Kitasato University Hospital
City
Sagamihara-shi
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto-shi
State/Province
Kumamoto,
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
State/Province
Kyoto-shi,
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Tachikawa General Hospital
City
Nagaoka-shi
State/Province
Niigata
ZIP/Postal Code
940-8621
Country
Japan
Facility Name
Niigata University Medical and Dental Hospital
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
National Crebral and Cardiovascular Center Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-8565
Country
Japan
Facility Name
Saitama Medical University International Medical Cnter
City
Hidaka-shi
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Chonnam National University
City
Gwangju
State/Province
Donggu
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Sejong General Hospital
City
Bucheon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
14754
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeongsang
ZIP/Postal Code
50612,
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
State/Province
Seodaemun-gu
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
41931
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Donostia
City
San Sebastián
ZIP/Postal Code
20014
Country
Spain
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Royal Stoke University Hospital
City
Stoke-on-Trent
State/Province
Staffordshire
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
Liverpool Heart and Chest - LHCH
City
Liverpool
ZIP/Postal Code
L14 3PE
Country
United Kingdom
Facility Name
St. Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP

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