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Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the Elderly

NCT02121158 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2024-07-31

Study results available
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Summary

The overall aim of this trial is to study the safety and efficacy of ICD implantation as a primary prevention strategy of sudden cardiac death in patients 70 years and older. This study will assess the many competing factors involved with ICD implantation including 1) the impact on mortality, especially in the context of a declining rate of sudden death with advanced age, 2) the tolerability of the powerful therapeutic action of the device, and 3) the impact on quality of life.

Conditions

Interventions

DEVICE

Implantable Cardioverter Defibrillator

The ICD and lead(s) will be FDA-approved.

OTHER

Optimal Medical Therapy

Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Steve Singh, MD · Washington DC VA Medical Center, Washington, DC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-07
Primary Completion
2020-11-06
Completion
2020-11-06
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT02121158 on ClinicalTrials.gov