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

NCT02923726 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2692

Last updated 2024-10-22

Study results available
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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.

Conditions

Interventions

DEVICE

Arm 1 (ATP+Shock)

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

DEVICE

Arm 2 (shock only)

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Claudio Schuger, M.D. · University of Rochester Clincal Cardiovascular Research Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2023-07-06
Completion
2023-07-06

Countries

  • United States
  • Austria
  • Canada
  • Italy
  • Japan
  • South Korea
  • Spain
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02923726 on ClinicalTrials.gov