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Sudden Cardiac DeathAPPRAISE ATPNCT02923726

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

A study testing Arm 1 (ATP+Shock) and Arm 2 (shock only) in people with Sudden Cardiac Death, run by Boston Scientific Corporation at 134 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Sudden Cardiac Death
What is being tested?
Arm 1 (ATP+Shock) and Arm 2 (shock only)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,692 participants
Where
134 sitesin 8 countries
Study dates
30 Sep 2016to 6 Jul 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

134 sites in 8 countries.

134 sites in 8 countries

United States89 sites

  • Comprehensive Cardiovascular Specialists

    Alhambra, California, 91801

  • Lehigh Valley Hospital Pocono

    Allentown, Pennsylvania, 18103

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Memorial Mission Hospital

    Asheville, North Carolina, 28803

  • Union Memorial Hospital

    Baltimore, Maryland, 21237

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Bradenton Cardiology

    Bradenton, Florida, 34205

  • Bryn Mawr Medical Specialists

    Bryn Mawr, Pennsylvania, 19146

  • Lahey Clinic Hospital

    Burlington, Massachusetts, 01805

  • Trident Medical Center

    Charleston, South Carolina, 29406

  • Charleston Area Medical Center

    Charleston, West Virginia, 25304

  • CorVita Science Foundation

    Chicago, Illinois, 60605

  • Adventist Hinsdale Hospital

    Chicago, Illinois, 60612

  • Scripps Mercy Chula Vista

    Chula Vista, California, 91910

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • VA North Texas Health Care System in Dallas

    Dallas, Texas, 75216

  • Cardiac Specialists

    Danbury, Connecticut, 06810

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • St. Luke's Hospital of Duluth

    Duluth, Minnesota, 55805

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007

  • Providence Regional Medical Centre Everett

    Everett, Washington, 98201

  • Southcoast Physicians Group

    Fall River, Massachusetts, 02720

  • Cardiology Consultants of East Michigan

    Flint, Michigan, 48532

  • McLeod Cardiology Associates

    Florence, South Carolina, 29506

  • Lutheran Medical Group

    Fort Wayne, Indiana, 46804

  • Apex Trials Group, LLC

    Fort Worth, Texas, 76104

  • The Cardiac and Vascular Institute Research Foundation

    Gainesville, Florida, 32605

  • Bellin Health

    Green Bay, Wisconsin, 54305

  • Cardiovascular Associates of the Delaware Valley.

    Haddon Heights, New Jersey, 08035

  • Heart and Vascular Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • University of Texas Houston Health Science Center

    Houston, Texas, 77030

  • Heart Center Research, LLC

    Huntsville, Alabama, 35801

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • St Vincent's Medical Center

    Jacksonville, Florida, 32204

  • Arrhythmia Research Group

    Jonesboro, Arkansas, 72401

  • Western Michigan University - Homer Stryker M.D. School of Medicine

    Kalamazoo, Michigan, 49048

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Heart of the Villages

    Lady Lake, Florida, 32159

  • Watson Clinic Center for Research, Inc

    Lakeland, Florida, 33805

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

  • Mass Heart and Rhythm

    Leominster, Massachusetts, 01453

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • South Denver Cardiology Associates PC

    Littleton, Colorado, 80120

  • VA Loma Linda

    Loma Linda, California, 92357

  • Cardiovascular Consultants Medical Group

    Los Angeles, California, 90024

  • Heart Institute of East Texas

    Lufkin, Texas, 75904

  • Bon Secours Heart & Vascular Institute

    Mechanicsville, Virginia, 23116

  • Tri-City Cardiology

    Mesa, Arizona, 85206

  • Ball Memorial Hospital

    Muncie, Indiana, 47303

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Mission Research Institute

    New Braunfels, Texas, 78130

  • Weill Cornell Medical University

    New York, New York, 10021

  • Christiana Hospital

    Newark, Delaware, 19805

  • The Arrhythmia Institute

    Newtown, Pennsylvania, 18940

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • McKay Dee Cardiology

    Ogden, Utah, 84403

  • The Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Overland Park Regional Medical Center

    Overland Park, Kansas, 66215

  • St. Joseph's Region Medical Center

    Paterson, New Jersey, 07503

  • Presbyterian University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Cardiovascular Consultants, LTD

    Phoenix, Arizona, 85032

  • Charlotte Heart & Vascular

    Port Charlotte, Florida, 33952

  • Monument Health Rapid City Hospital, Inc.

    Rapid City, South Dakota, 57701

  • Virginia Cardiovascular Specialist

    Richmond, Virginia, 23225

  • Brevard Cardiovascular Research Associates, Inc

    Rockledge, Florida, 32955

  • Mercy Clinic Cardiology

    Rogers, Arkansas, 72758

  • Great Lakes Heart & Vascular Institute

    Saint Joseph, Michigan, 49085

  • Richard A. Henson Research Institute of Peninsula Regional Medical Center

    Salisbury, Maryland, 21804

  • University of Utah Hospitals and Clinics

    Salt Lake City, Utah, 84132

  • VA Salt Lake City Health System

    Salt Lake City, Utah, 84148

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Louisiana State University

    Shreveport, Louisiana, 71103

  • Cox Health

    Springfield, Missouri, 65807

  • Stamford Hospital

    Stamford, Connecticut, 06902

  • Regional Cardiac Arrhythmia, Inc

    Steubenville, Ohio, 43952

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • AdventHeatlh Tampa

    Tampa, Florida, 33624

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • PeaceHealth Southwest Medical

    Vancouver, Washington, 98664

  • Lexington Medical Center

    West Columbia, South Carolina, 29169

  • Mercy Hospital Medical Center

    West Des Moines, Iowa, 50266

  • Mount Carmel Columbus Cardiology Consultants

    Westerville, Ohio, 43801

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

  • Metro Health Hospital

    Wyoming, Michigan, 49519

  • St. Joseph Mercy Hospital

    Ypsilanti, Michigan, 48197

  • Yuma Regional Medical Center

    Yuma, Arizona, 85364

Other trials in United States

South Korea12 sites

  • Sejong General Hospital

    Bucheon-si, Gyeonggi-do, 14754

  • Inje University Busan Paik Hospital

    Busan, 47392

  • Keimyung University Dongsan Medical Center

    Daegu, 41931

  • Kyungpook National University Hospital

    Daegu, 41944

  • Chonnam National University

    Gwangju, Donggu, 501-757

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Samsung Medical Center

    Seoul, Gangnam-gu, 06351

  • Severance Hospital, Yonsei University Health System

    Seoul, Seodaemun-gu, 120-752

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsang, 50612,

Other trials in South Korea

Japan9 sites

  • Chiba University Hospital

    Chiba, Chiba, 260-8677

  • Saitama Medical University International Medical Cnter

    Hidaka-shi, Saitama, 350-1298

  • Kokura Memorial Hospital

    Kitakyushu-Shi, Fukuoka, 802-8555

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, 860-8556

  • Kyoto University Hospital

    Kyoto, Kyoto-shi,, 606-8507

  • Tachikawa General Hospital

    Nagaoka-shi, Niigata, 940-8621

  • Niigata University Medical and Dental Hospital

    Niigata, Niigata, 951-8520

  • Kitasato University Hospital

    Sagamihara-shi, Kanagawa, 252-0375

  • National Crebral and Cardiovascular Center Hospital

    Suita, Osaka, 565-8565

Other trials in Japan

Canada8 sites

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

  • Institut de Cardiologie de Montreal

    Montreal, Quebec, H1T 1C8

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2W 1T8

  • Royal Columbian Hospital

    New Westminster, British Columbia, V3L 3W4

  • Institut universitaire de Cardiologie et de Pneumologie de Quebec.

    Québec, Quebec, G1V 4G5

  • Scarborough Health Network-Centenary Site

    Scarborough Village, Ontario, M1B 4Z8

  • Victoria Cardiac Arrhythmia Trials, Inc.

    Victoria, British Columbia, V8T 1Z4

Other trials in Canada

Italy6 sites

  • Policlinico di Modena

    Modena, Emilia-Romagna, 41124

  • Presidio Ospedale San Giovanni Bosco

    Naples, 80100

  • Hospital Buon Consiglio

    Naples, 80123

  • Ospedale dei Pellegrini

    Naples, 8133

  • Osp. Civile S. Maria Delle Grazie

    Pozzuoli, Southern Cluster, 80018

  • Az. Osp. S. Andrea

    Rome, 00189

Other trials in Italy

United Kingdom5 sites

  • Royal Bournemouth Hospital

    Bournemouth, Dorset, BH7 7DW

  • Liverpool Heart and Chest - LHCH

    Liverpool, L14 3PE

  • St. Bartholomew's Hospital

    London, EC1A 7BE

  • King's College Hospital

    London, SE5 9RS

  • Royal Stoke University Hospital

    Stoke-on-Trent, Staffordshire, ST4 6QG

Other trials in United Kingdom

Spain3 sites

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital La Paz

    Madrid, 28046

  • Hospital Donostia

    San Sebastián, 20014

Other trials in Spain

Austria2 sites

  • Kepler Universitaetsklinikum GmbH

    Linz, 4021

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

About this study

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

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.

Being tested
Arm 1 (ATP+Shock), Arm 2 (shock only)
Keywords
Antitachycardia Pacing Therapy, Shock Therapy, Primary Prevention
Medical subject headings
Death, Sudden, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arm 1 (ATP+Shock)Device

    Subjects will be randomized and device programmed to the respective arm.

  • Arm 2 (shock only)Device

    Subjects will be randomized and device programmed to the respective arm.

Study groups in NCT02923726
Study groupRoleWhat they receive
ATP and ShockActive comparatorOnce tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy.
Receives: Device: Arm 1 (ATP+Shock)
Shock onlyExperimentalOnce tachycardia has been detected and duration met, this group would receive shock therapy only.
Receives: Device: Arm 2 (shock only)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-Cause Shock

    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.

    Measured: 5 years

Secondary outcomes (4)

  1. All-Cause Shock or Death From Any Cause

    incidence of all-cause shocks or death from any cause

    Measured: 5 years

  2. Appropriate Shock

    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.

    Measured: 5 years

  3. Inappropriate Shock

    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.

    Measured: 5 years

  4. All Cause Mortality

    incidents of all cause mortality

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2016 (estimated)
  2. Study start30 Sep 2016
  3. Primary completion6 Jul 2023
  4. Study completion6 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
2,692 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02923726
Sponsor's protocol ID
C1924
Acronym
APPRAISE ATP
Status last verified
Sep 2024
First submitted
3 Oct 2016
Last updated
22 Oct 2024
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Schuger C, Joung B, Ando K, Mont L, Lambiase PD, O'Hara GE, Jennings JM, Yung D, Boriani G, Piccini JP, Wold N, Stein KM, Daubert JP; APPRAISE ATP Investigators. Assessment of Antitachycardia Pacing in Primary Prevention Patients: The APPRAISE ATP Randomized Clinical Trial. JAMA. 2024 Nov 26;332(20):1723-1731. doi: 10.1001/jama.2024.16531.

    PubMed 39361311

Questions about this trial

What is this clinical trial studying?

A study testing Arm 1 (ATP+Shock) and Arm 2 (shock only) in people with Sudden Cardiac Death, run by Boston Scientific Corporation at 134 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in United States, South Korea, Japan, Canada, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-Cause Shock (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02923726, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.

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