Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
- Conditions
- Sudden Cardiac Death
- Interventions
- Device: Arm 1 (ATP+Shock)Device: Arm 2 (shock only)
- Registration Number
- NCT02923726
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The primary objective is to understand the role of antitachycardia pacing (ATP) in primary prevention patients indicated for implantable cardioverter-defibrillator (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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2692
-
Subject with a Boston Scientific transvenous ICD (de novo implant or upgrade from pacemaker to ICD) implanted because of one of the following:
- Prior myocardial infarction (MI) and left ventricular ejection fraction (LVEF) ≤ 30% OR
- Ischemic or non-ischemic cardiomyopathy, and LVEF ≤ 35%, and a New York Heart Association (NYHA) class II or III
-
Subject is age 21 or 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
- 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 transvenous ICD (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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ATP and Shock Arm 1 (ATP+Shock) Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy. Shock only Arm 2 (shock only) Once tachycardia has been detected and duration met, this group would receive shock therapy only.
- Primary Outcome Measures
Name Time Method All-Cause Shock 5 years The incidence of all-cause shocks in subjects programmed with shocks only will be compared with subjects programmed to standard therapy (ATP and shock) to assess equivalency. All shocks delivered by the device were adjudicated by an external committee as to whether they were appropriately or inappropriately delivered. All shocks, appropriate and inappropriate, contributed to the evaluation of this endpoint.
- Secondary Outcome Measures
Name Time Method All-Cause Shock or Death From Any Cause 5 years incidence of all-cause shocks or death from any cause
Appropriate Shock 5 years incidence of first appropriate shock All shocks delivered by the device were adjudicated by an external committee as to whether they were appropriately or inappropriately delivered. Appropriate shocks contributed to the evaluation of this endpoint.
Inappropriate Shock 5 years incidence of first inappropriate shock All shocks delivered by the device were adjudicated by an external committee as to whether they were appropriately or inappropriately delivered. Inappropriate shocks contributed to the evaluation of this endpoint.
All Cause Mortality 5 years incidents of all cause mortality
Trial Locations
- Locations (134)
Southcoast Physicians Group
🇺🇸Fall River, Massachusetts, United States
Heart and Vascular Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
Presbyterian University of Pennsylvania Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
VA North Texas Health Care System in Dallas
🇺🇸Dallas, Texas, United States
McKay Dee Cardiology
🇺🇸Ogden, Utah, United States
Charleston Area Medical Center
🇺🇸Charleston, West Virginia, United States
Victoria Cardiac Arrhythmia Trials, Inc.
🇨🇦Victoria, British Columbia, Canada
CorVita Science Foundation
🇺🇸Chicago, Illinois, United States
Adventist Hinsdale Hospital
🇺🇸Chicago, Illinois, United States
Scripps Mercy Chula Vista
🇺🇸Chula Vista, California, United States
Bradenton Cardiology
🇺🇸Bradenton, Florida, United States
Heart of the Villages
🇺🇸Lady Lake, Florida, United States
Louisiana State University
🇺🇸Shreveport, Louisiana, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Providence Regional Medical Centre Everett
🇺🇸Everett, Washington, United States
Kepler Universitaetsklinikum GmbH
🇦🇹Linz, Austria
Royal Columbian Hospital
🇨🇦New Westminster, British Columbia, Canada
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
University of Texas Houston Health Science Center
🇺🇸Houston, Texas, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Kettering Medical Center
🇺🇸Kettering, Ohio, United States
University of Utah Hospitals and Clinics
🇺🇸Salt Lake City, Utah, United States
Overland Park Regional Medical Center
🇺🇸Overland Park, Kansas, United States
St. Luke's Hospital of Duluth
🇺🇸Duluth, Minnesota, United States
South Denver Cardiology Associates PC
🇺🇸Littleton, Colorado, United States
Cardiovascular Consultants, LTD
🇺🇸Phoenix, Arizona, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Lahey Clinic Hospital
🇺🇸Burlington, Massachusetts, United States
Kitasato University Hospital
🇯🇵Sagamihara-shi, Kanagawa, Japan
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Gyeongsang, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
The Cardiac and Vascular Institute Research Foundation
🇺🇸Gainesville, Florida, United States
Stamford Hospital
🇺🇸Stamford, Connecticut, United States
Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Kyoto University Hospital
🇯🇵Kyoto, Kyoto-shi,, Japan
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Christiana Hospital
🇺🇸Newark, Delaware, United States
Mass Heart and Rhythm
🇺🇸Leominster, Massachusetts, United States
St. Joseph Mercy Hospital
🇺🇸Ypsilanti, Michigan, United States
McLeod Cardiology Associates
🇺🇸Florence, South Carolina, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Saitama Medical University International Medical Cnter
🇯🇵Hidaka-shi, Saitama, Japan
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Seodaemun-gu, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Cardiovascular Associates of the Delaware Valley.
🇺🇸Haddon Heights, New Jersey, United States
Mercy Clinic Cardiology
🇺🇸Rogers, Arkansas, United States
Brevard Cardiovascular Research Associates, Inc
🇺🇸Rockledge, Florida, United States
Klinikum Wels-Grieskirchen GmbH
🇦🇹Wels, Austria
Institut de Cardiologie de Montreal
🇨🇦Montréal, Quebec, Canada
Institut universitaire de Cardiologie et de Pneumologie de Quebec.
🇨🇦Quebec City, Quebec, Canada
Arrhythmia Research Group
🇺🇸Jonesboro, Arkansas, United States
Bellin Health
🇺🇸Green Bay, Wisconsin, United States
Richard A. Henson Research Institute of Peninsula Regional Medical Center
🇺🇸Salisbury, Maryland, United States
Great Lakes Heart & Vascular Institute
🇺🇸Saint Joseph, Michigan, United States
Metro Health Hospital
🇺🇸Wyoming, Michigan, United States
Watson Clinic Center for Research, Inc
🇺🇸Lakeland, Florida, United States
Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
Yuma Regional Medical Center
🇺🇸Yuma, Arizona, United States
Western Michigan University - Homer Stryker M.D. School of Medicine
🇺🇸Kalamazoo, Michigan, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
St. Joseph's Region Medical Center
🇺🇸Paterson, New Jersey, United States
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
Presidio Ospedale San Giovanni Bosco
🇮🇹Napoli, Italy
Kumamoto University Hospital
🇯🇵Kumamoto-shi, Kumamoto,, Japan
Niigata University Medical and Dental Hospital
🇯🇵Niigata-shi, Niigata, Japan
Chonnam National University
🇰🇷Gwangju, Donggu, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Gangnam-gu, Korea, Republic of
Sejong General Hospital
🇰🇷Bucheon-si, Gyeonggi-do, Korea, Republic of
Royal Stoke University Hospital
🇬🇧Stoke-on-Trent, Staffordshire, United Kingdom
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
Royal Bournemouth Hospital
🇬🇧Bournemouth, Dorset, United Kingdom
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
The Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Hospital La Paz
🇪🇸Madrid, Spain
Heart Center Research, LLC
🇺🇸Huntsville, Alabama, United States
Tri-City Cardiology
🇺🇸Mesa, Arizona, United States
Comprehensive Cardiovascular Specialists
🇺🇸Alhambra, California, United States
Cardiovascular Consultants Medical Group
🇺🇸Los Angeles, California, United States
VA Loma Linda
🇺🇸Loma Linda, California, United States
Cardiac Specialists
🇺🇸Danbury, Connecticut, United States
St Vincent's Medical Center
🇺🇸Jacksonville, Florida, United States
Charlotte Heart & Vascular
🇺🇸Port Charlotte, Florida, United States
Tallahassee Memorial Hospital
🇺🇸Tallahassee, Florida, United States
Alexian Brothers Medical Center
🇺🇸Elk Grove Village, Illinois, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Lutheran Medical Group
🇺🇸Fort Wayne, Indiana, United States
Mercy Hospital Medical Center
🇺🇸West Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Ball Memorial Hospital
🇺🇸Muncie, Indiana, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Cardiology Consultants of East Michigan
🇺🇸Flint, Michigan, United States
Weill Cornell Medical University
🇺🇸New York, New York, United States
Cox Health
🇺🇸Springfield, Missouri, United States
Memorial Mission Hospital
🇺🇸Asheville, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Bryn Mawr Medical Specialists
🇺🇸Bryn Mawr, Pennsylvania, United States
The Arrhythmia Institute
🇺🇸Newtown, Pennsylvania, United States
Mount Carmel Columbus Cardiology Consultants
🇺🇸Westerville, Ohio, United States
Regional Cardiac Arrhythmia, Inc
🇺🇸Steubenville, Ohio, United States
Lehigh Valley Hospital Pocono
🇺🇸Allentown, Pennsylvania, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Lexington Medical Center
🇺🇸West Columbia, South Carolina, United States
Monument Health Rapid City Hospital, Inc.
🇺🇸Rapid City, South Dakota, United States
Apex Trials Group, LLC
🇺🇸Fort Worth, Texas, United States
Heart Institute of East Texas
🇺🇸Lufkin, Texas, United States
Mission Research Institute
🇺🇸New Braunfels, Texas, United States
VA Salt Lake City Health System
🇺🇸Salt Lake City, Utah, United States
PeaceHealth Southwest Medical
🇺🇸Vancouver, Washington, United States
Virginia Cardiovascular Specialist
🇺🇸Richmond, Virginia, United States
Bon Secours Heart & Vascular Institute
🇺🇸Mechanicsville, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Scarborough Health Network-Centenary Site
🇨🇦Scarborough, Ontario, Canada
Policlinico di Modena
🇮🇹Modena, Emilia-Romagna, Italy
Osp. Civile S. Maria Delle Grazie
🇮🇹Pozzuoli, Southern Cluster, Italy
Ospedale dei Pellegrini
🇮🇹Napoli, Italy
Hospital Buon Consiglio
🇮🇹Napoli, Italy
Chiba University Hospital
🇯🇵Chiba-shi, Chiba, Japan
Az. Osp. S. Andrea
🇮🇹Rome, Italy
Kokura Memorial Hospital
🇯🇵Kitakyushu-Shi, Fukuoka, Japan
Tachikawa General Hospital
🇯🇵Nagaoka-shi, Niigata, Japan
National Crebral and Cardiovascular Center Hospital
🇯🇵Suita, Osaka, Japan
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Hospital Donostia
🇪🇸San Sebastián, Spain
St. Bartholomew's Hospital
🇬🇧London, United Kingdom
Liverpool Heart and Chest - LHCH
🇬🇧Liverpool, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom
AdventHeatlh Tampa
🇺🇸Tampa, Florida, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Trident Medical Center
🇺🇸Charleston, South Carolina, United States