Clinical trial NCT02923726: Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
Official title: Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP (APPRAISE ATP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sudden Cardiac Death
Keywords: Antitachycardia Pacing Therapy
Shock Therapy
Primary Prevention
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2016-10-05
Enrollment: 2692
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion 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 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

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 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

Primary outcomes:
measure: All-Cause Shock
timeFrame: 5 years
Secondary outcomes:
measure: All-Cause Shock or Death From Any Cause
timeFrame: 5 years
measure: Appropriate Shock
timeFrame: 5 years
measure: Inappropriate Shock
timeFrame: 5 years
measure: All Cause Mortality
timeFrame: 5 years
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Anchorage
country: United States
facility: Providence Alaska Medical Center
state: Alaska
city: Mesa
country: United States
facility: Tri-City Cardiology
state: Arizona
city: Phoenix
country: United States
facility: Cardiovascular Consultants, LTD
state: Arizona
city: Yuma
country: United States
facility: Yuma Regional Medical Center
state: Arizona
city: Jonesboro
country: United States
facility: Arrhythmia Research Group
state: Arkansas
city: Rogers
country: United States
facility: Mercy Clinic Cardiology
state: Arkansas
city: Alhambra
country: United States
facility: Comprehensive Cardiovascular Specialists
state: California
city: Chula Vista
country: United States
facility: Scripps Mercy Chula Vista
state: California
city: Loma Linda
country: United States
facility: VA Loma Linda
state: California
city: Los Angeles
country: United States
facility: Cardiovascular Consultants Medical Group
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Littleton
country: United States
facility: South Denver Cardiology Associates PC
state: Colorado
city: Danbury
country: United States
facility: Cardiac Specialists
state: Connecticut
city: Stamford
country: United States
facility: Stamford Hospital
state: Connecticut
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Bradenton
country: United States
facility: Bradenton Cardiology
state: Florida
city: Gainesville
country: United States
facility: The Cardiac and Vascular Institute Research Foundation
state: Florida
city: Jacksonville
country: United States
facility: St Vincent's Medical Center
state: Florida
city: Lady Lake
country: United States
facility: Heart of the Villages
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Center for Research, Inc
state: Florida
city: Port Charlotte
country: United States
facility: Charlotte Heart & Vascular
state: Florida
city: Rockledge
country: United States
facility: Brevard Cardiovascular Research Associates, Inc
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: AdventHeatlh Tampa
state: Florida
city: Chicago
country: United States
facility: CorVita Science Foundation
state: Illinois
city: Chicago
country: United States
facility: Adventist Hinsdale Hospital
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Fort Wayne
country: United States
facility: Lutheran Medical Group
state: Indiana
city: Muncie
country: United States
facility: Ball Memorial Hospital
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: West Des Moines
country: United States
facility: Mercy Hospital Medical Center
state: Iowa
city: Overland Park
country: United States
facility: Overland Park Regional Medical Center
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Shreveport
country: United States
facility: Louisiana State University
state: Louisiana
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Salisbury
country: United States
facility: Richard A. Henson Research Institute of Peninsula Regional Medical Center
state: Maryland
city: Burlington
country: United States
facility: Lahey Clinic Hospital
state: Massachusetts
city: Fall River
country: United States
facility: Southcoast Physicians Group
state: Massachusetts
city: Leominster
country: United States
facility: Mass Heart and Rhythm
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Flint
country: United States
facility: Cardiology Consultants of East Michigan
state: Michigan
city: Kalamazoo
country: United States
facility: Western Michigan University - Homer Stryker M.D. School of Medicine
state: Michigan
city: Saint Joseph
country: United States
facility: Great Lakes Heart & Vascular Institute
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Wyoming
country: United States
facility: Metro Health Hospital
state: Michigan
city: Ypsilanti
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Duluth
country: United States
facility: St. Luke's Hospital of Duluth
state: Minnesota
city: Hattiesburg
country: United States
facility: Heart and Vascular Hattiesburg Clinic
state: Mississippi
city: Springfield
country: United States
facility: Cox Health
state: Missouri
city: Omaha
country: United States
facility: The Nebraska Medical Center
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Haddon Heights
country: United States
facility: Cardiovascular Associates of the Delaware Valley.
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Paterson
country: United States
facility: St. Joseph's Region Medical Center
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medical University
state: New York
city: Asheville
country: United States
facility: Memorial Mission Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Steubenville
country: United States
facility: Regional Cardiac Arrhythmia, Inc
state: Ohio
city: Westerville
country: United States
facility: Mount Carmel Columbus Cardiology Consultants
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital Pocono
state: Pennsylvania
city: Bryn Mawr
country: United States
facility: Bryn Mawr Medical Specialists
state: Pennsylvania
city: Newtown
country: United States
facility: The Arrhythmia Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Presbyterian University of Pennsylvania Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Trident Medical Center
state: South Carolina
city: Florence
country: United States
facility: McLeod Cardiology Associates
state: South Carolina
city: West Columbia
country: United States
facility: Lexington Medical Center
state: South Carolina
city: Rapid City
country: United States
facility: Monument Health Rapid City Hospital, Inc.
state: South Dakota
city: Dallas
country: United States
facility: VA North Texas Health Care System in Dallas
state: Texas
city: Fort Worth
country: United States
facility: Apex Trials Group, LLC
state: Texas
city: Houston
country: United States
facility: University of Texas Houston Health Science Center
state: Texas
city: Lufkin
country: United States
facility: Heart Institute of East Texas
state: Texas
city: New Braunfels
country: United States
facility: Mission Research Institute
state: Texas
city: Ogden
country: United States
facility: McKay Dee Cardiology
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Hospitals and Clinics
state: Utah
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health System
state: Utah
city: Mechanicsville
country: United States
facility: Bon Secours Heart & Vascular Institute
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Cardiovascular Specialist
state: Virginia
city: Everett
country: United States
facility: Providence Regional Medical Centre Everett
state: Washington
city: Vancouver
country: United States
facility: PeaceHealth Southwest Medical
state: Washington
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Green Bay
country: United States
facility: Bellin Health
state: Wisconsin
city: Linz
country: Austria
facility: Kepler Universitaetsklinikum GmbH
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Victoria Cardiac Arrhythmia Trials, Inc.
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Scarborough
country: Canada
facility: Scarborough Health Network-Centenary Site
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Montréal
country: Canada
facility: Institut de Cardiologie de Montreal
state: Quebec
city: Quebec City
country: Canada
facility: Institut universitaire de Cardiologie et de Pneumologie de Quebec.
state: Quebec
city: Modena
country: Italy
facility: Policlinico di Modena
state: Emilia-Romagna
city: Pozzuoli
country: Italy
facility: Osp. Civile S. Maria Delle Grazie
state: Southern Cluster
city: Napoli
country: Italy
facility: Presidio Ospedale San Giovanni Bosco
city: Napoli
country: Italy
facility: Hospital Buon Consiglio
city: Napoli
country: Italy
facility: Ospedale dei Pellegrini
city: Rome
country: Italy
facility: Az. Osp. S. Andrea
city: Chiba-shi
country: Japan
facility: Chiba University Hospital
state: Chiba
city: Kitakyushu-Shi
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Sagamihara-shi
country: Japan
facility: Kitasato University Hospital
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Kumamoto University Hospital
state: Kumamoto,
city: Kyoto
country: Japan
facility: Kyoto University Hospital
state: Kyoto-shi,
city: Nagaoka-shi
country: Japan
facility: Tachikawa General Hospital
state: Niigata
city: Niigata-shi
country: Japan
facility: Niigata University Medical and Dental Hospital
state: Niigata
city: Suita
country: Japan
facility: National Crebral and Cardiovascular Center Hospital
state: Osaka
city: Hidaka-shi
country: Japan
facility: Saitama Medical University International Medical Cnter
state: Saitama
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University
state: Donggu
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
city: Bucheon-si
country: Korea, Republic of
facility: Sejong General Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsang
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seodaemun-gu
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Madrid
country: Spain
facility: Hospital La Paz
city: San Sebastián
country: Spain
facility: Hospital Donostia
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
state: Dorset
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital
state: Staffordshire
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest - LHCH
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: University of Rochester Clincal Cardiovascular Research Center
name: Claudio Schuger, M.D.
role: PRINCIPAL_INVESTIGATOR
References: