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

Completed · Not applicable

Conditions studied: Sudden Cardiac Death

In brief

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.

Key facts

Study ID

NCT02923726

Run by

Boston Scientific Corporation

People needed

2692

Starts

2016-09-30

Expected to finish

2023-07-06

Last updated by the study team

2024-10-22

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Providence Alaska Medical Center — Anchorage, Alaska, United States
• Tri-City Cardiology — Mesa, Arizona, United States
• Cardiovascular Consultants, LTD — Phoenix, Arizona, United States
• Yuma Regional Medical Center — Yuma, Arizona, United States
• Arrhythmia Research Group — Jonesboro, Arkansas, United States
• Mercy Clinic Cardiology — Rogers, Arkansas, United States
• Comprehensive Cardiovascular Specialists — Alhambra, California, United States
• Scripps Mercy Chula Vista — Chula Vista, California, United States
• VA Loma Linda — Loma Linda, California, United States
• Cardiovascular Consultants Medical Group — Los Angeles, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• South Denver Cardiology Associates PC — Littleton, Colorado, United States
• Cardiac Specialists — Danbury, Connecticut, United States
• Stamford Hospital — Stamford, Connecticut, United States
• Christiana Hospital — Newark, Delaware, United States
• Bradenton Cardiology — Bradenton, Florida, United States
• The Cardiac and Vascular Institute Research Foundation — Gainesville, Florida, United States
• St Vincent's Medical Center — Jacksonville, Florida, United States
• Heart of the Villages — Lady Lake, Florida, United States
• Watson Clinic Center for Research, Inc — Lakeland, Florida, United States
• Charlotte Heart & Vascular — Port Charlotte, Florida, United States
• Brevard Cardiovascular Research Associates, Inc — Rockledge, Florida, United States
• Tallahassee Memorial Hospital — Tallahassee, Florida, United States
• AdventHeatlh Tampa — Tampa, Florida, United States
• Heart Center Research, LLC — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.