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

Sudden Cardiac Death Clinical Trial

— APPRAISE ATP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02923726
• Other study ID #: C1924
• Status: Completed
• Phase: N/A
• Start date: September 30, 2016
• Est. completion date: July 6, 2023

Study information

• Verified date: June 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2600
• Est. completion date: July 6, 2023
• Est. primary completion date: July 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Sudden Cardiac Death

Intervention

Device:
• Arm 1 (ATP+Shock)
Subjects will be randomized and device programmed to the respective arm.
• Arm 2 (shock only)
Subjects will be randomized and device programmed to the respective arm.

Locations

Country	Name	City	State
Austria	Kepler Universitaetsklinikum GmbH	Linz
Austria	Klinikum Wels-Grieskirchen GmbH	Wels
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	Institut de Cardiologie de Montreal	Montréal	Quebec
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Canada	Institut universitaire de Cardiologie et de Pneumologie de Quebec.	Quebec City	Quebec
Canada	Scarborough Health Network-Centenary Site	Scarborough	Ontario
Canada	Victoria Cardiac Arrhythmia Trials, Inc.	Victoria	British Columbia
Italy	Policlinico di Modena	Modena	Emilia-Romagna
Italy	Hospital Buon Consiglio	Napoli
Italy	Ospedale dei Pellegrini	Napoli
Italy	Presidio Ospedale San Giovanni Bosco	Napoli
Italy	Osp. Civile S. Maria Delle Grazie	Pozzuoli	Southern Cluster
Italy	Az. Osp. S. Andrea	Rome
Japan	Chiba University Hospital	Chiba-shi	Chiba
Japan	Saitama Medical University International Medical Cnter	Hidaka-shi	Saitama
Japan	Kokura Memorial Hospital	Kitakyushu-Shi	Fukuoka
Japan	Kumamoto University Hospital	Kumamoto-shi	Kumamoto,
Japan	Kyoto University Hospital	Kyoto	Kyoto-shi,
Japan	Tachikawa General Hospital	Nagaoka-shi	Niigata
Japan	Niigata University Medical and Dental Hospital	Niigata-shi	Niigata
Japan	Kitasato University Hospital	Sagamihara-shi	Kanagawa
Japan	National Crebral and Cardiovascular Center Hospital	Suita	Osaka
Korea, Republic of	Sejong General Hospital	Bucheon-si	Gyeonggi-do
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Chonnam National University	Gwangju	Donggu
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul	Gangnam-gu
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul	Seodaemun-gu
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeongsang
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital La Paz	Madrid
Spain	Hospital Donostia	San Sebastián
United Kingdom	Royal Bournemouth Hospital	Bournemouth	Dorset
United Kingdom	Liverpool Heart and Chest - LHCH	Liverpool
United Kingdom	King's College Hospital	London
United Kingdom	St. Bartholomew's Hospital	London
United Kingdom	Royal Stoke University Hospital	Stoke-on-Trent	Staffordshire
United States	Comprehensive Cardiovascular Specialists	Alhambra	California
United States	Lehigh Valley Hospital Pocono	Allentown	Pennsylvania
United States	Providence Alaska Medical Center	Anchorage	Alaska
United States	Memorial Mission Hospital	Asheville	North Carolina
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Union Memorial Hospital	Baltimore	Maryland
United States	Bradenton Cardiology	Bradenton	Florida
United States	Bryn Mawr Medical Specialists	Bryn Mawr	Pennsylvania
United States	Lahey Clinic Hospital	Burlington	Massachusetts
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	Trident Medical Center	Charleston	South Carolina
United States	Adventist Hinsdale Hospital	Chicago	Illinois
United States	CorVita Science Foundation	Chicago	Illinois
United States	Scripps Mercy Chula Vista	Chula Vista	California
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	VA North Texas Health Care System in Dallas	Dallas	Texas
United States	Cardiac Specialists	Danbury	Connecticut
United States	Henry Ford Hospital	Detroit	Michigan
United States	St. Luke's Hospital of Duluth	Duluth	Minnesota
United States	Duke University Medical Center	Durham	North Carolina
United States	Alexian Brothers Medical Center	Elk Grove Village	Illinois
United States	Providence Regional Medical Centre Everett	Everett	Washington
United States	Southcoast Physicians Group	Fall River	Massachusetts
United States	Cardiology Consultants of East Michigan	Flint	Michigan
United States	McLeod Cardiology Associates	Florence	South Carolina
United States	Lutheran Medical Group	Fort Wayne	Indiana
United States	Apex Trials Group, LLC	Fort Worth	Texas
United States	The Cardiac and Vascular Institute Research Foundation	Gainesville	Florida
United States	Bellin Health	Green Bay	Wisconsin
United States	Cardiovascular Associates of the Delaware Valley.	Haddon Heights	New Jersey
United States	Heart and Vascular Hattiesburg Clinic	Hattiesburg	Mississippi
United States	University of Texas Houston Health Science Center	Houston	Texas
United States	Heart Center Research, LLC	Huntsville	Alabama
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	St Vincent's Medical Center	Jacksonville	Florida
United States	Arrhythmia Research Group	Jonesboro	Arkansas
United States	Western Michigan University - Homer Stryker M.D. School of Medicine	Kalamazoo	Michigan
United States	Kettering Medical Center	Kettering	Ohio
United States	Heart of the Villages	Lady Lake	Florida
United States	Watson Clinic Center for Research, Inc	Lakeland	Florida
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Mass Heart and Rhythm	Leominster	Massachusetts
United States	Baptist Health Lexington	Lexington	Kentucky
United States	South Denver Cardiology Associates PC	Littleton	Colorado
United States	VA Loma Linda	Loma Linda	California
United States	Cardiovascular Consultants Medical Group	Los Angeles	California
United States	Heart Institute of East Texas	Lufkin	Texas
United States	Bon Secours Heart & Vascular Institute	Mechanicsville	Virginia
United States	Tri-City Cardiology	Mesa	Arizona
United States	Ball Memorial Hospital	Muncie	Indiana
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Mission Research Institute	New Braunfels	Texas
United States	Weill Cornell Medical University	New York	New York
United States	Christiana Hospital	Newark	Delaware
United States	The Arrhythmia Institute	Newtown	Pennsylvania
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	McKay Dee Cardiology	Ogden	Utah
United States	The Nebraska Medical Center	Omaha	Nebraska
United States	Overland Park Regional Medical Center	Overland Park	Kansas
United States	St. Joseph's Region Medical Center	Paterson	New Jersey
United States	Presbyterian University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Cardiovascular Consultants, LTD	Phoenix	Arizona
United States	Charlotte Heart & Vascular	Port Charlotte	Florida
United States	Monument Health Rapid City Hospital, Inc.	Rapid City	South Dakota
United States	Virginia Cardiovascular Specialist	Richmond	Virginia
United States	Brevard Cardiovascular Research Associates, Inc	Rockledge	Florida
United States	Mercy Clinic Cardiology	Rogers	Arkansas
United States	Great Lakes Heart & Vascular Institute	Saint Joseph	Michigan
United States	Richard A. Henson Research Institute of Peninsula Regional Medical Center	Salisbury	Maryland
United States	University of Utah Hospitals and Clinics	Salt Lake City	Utah
United States	VA Salt Lake City Health System	Salt Lake City	Utah
United States	Sharp Memorial Hospital	San Diego	California
United States	Louisiana State University	Shreveport	Louisiana
United States	Cox Health	Springfield	Missouri
United States	Stamford Hospital	Stamford	Connecticut
United States	Regional Cardiac Arrhythmia, Inc	Steubenville	Ohio
United States	Tallahassee Memorial Hospital	Tallahassee	Florida
United States	AdventHeatlh Tampa	Tampa	Florida
United States	Munson Medical Center	Traverse City	Michigan
United States	PeaceHealth Southwest Medical	Vancouver	Washington
United States	Lexington Medical Center	West Columbia	South Carolina
United States	Mercy Hospital Medical Center	West Des Moines	Iowa
United States	Mount Carmel Columbus Cardiology Consultants	Westerville	Ohio
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts
United States	Metro Health Hospital	Wyoming	Michigan
United States	St. Joseph Mercy Hospital	Ypsilanti	Michigan
United States	Yuma Regional Medical Center	Yuma	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Italy,  Japan,  Korea, Republic of,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From 60 days post implant up to five years
Secondary	• All-cause mortality		From 60 days post implant up to five years
Secondary	Time to first appropriate shock		From 60 days post implant up to five years
Secondary	Time to first inappropriate shock		From 60 days post implant up to five years