Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the Elderly (I-70)

December 21, 2021 updated by: VA Office of Research and Development

CSP #592 - Efficacy and Safety of ICD Implantation in the Elderly

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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 (SCD) in patients 70 years and older. In particular, this study is designed to determine the comparative effectiveness of ICD, in addition to optimal medical therapy (OMT), in reducing all-cause mortality, versus OMT alone; OMT includes standard intervention for chronic heart failure patients, i.e. lifestyle modification, disease management, adoption of healthy diet and exercise practices, etcetera. One particularly important secondary objective is to assess treatment efficacy under the conditions of high versus low co-morbidity burden.

Participants will be randomized (1:1 ratio) to ICD + OMT or OMT alone, and stratified by participating site and co-morbidity level (Charlson score <3 versus 3+). Acute treatment visits will occur as clinically indicated and per local convention; follow-up will occur 1-4 months post-randomization (all participants), and not sooner than 30 days - and not later than 120 days post-implantation (ICD arm); regular follow-up will occur at 6 month intervals post-randomization until study close (all participants). All follow-up will be conducted centrally. Neither the participant nor treating clinician will be masked to treatment.

Primary Objective:

The primary objective of this study is to determine if a primary prevention strategy with ICD implantation in addition to optimal medical therapy (OMT) is effective in reducing all-cause mortality compared to OMT alone in patients 70 years of age and older who are eligible for ICD therapy according to current Centers for Medicare & Medicaid Services (CMS) criteria.

Primary Hypothesis:

The primary hypothesis of this study is that implantation of an ICD plus optimal medical therapy will reduce all-cause mortality in patients 70 years of age and older versus optimal medical therapy alone.

Secondary Objectives:

  1. One secondary objective of this study is to ascertain whether age, co-morbidity burden, or age and burden together, are determinants in mortality outcomes in the OMT versus ICD + OMT group.
  2. An additional secondary objective of the study is to determine the effect of ICD implantation plus optimal medical therapy on quality of life among elderly patients compared with optimal medical therapy alone.

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Washington DC VA Medical Center, Washington, DC
    • Florida
      • Gainesville, Florida, United States, 32608
        • North Florida/South Georgia Veterans Health System, Gainesville, FL
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VA Health Care System, Minneapolis, MN
    • Oregon
      • Portland, Oregon, United States, 97239
        • VA Portland Health Care System, Portland, OR
    • Tennessee
      • Nashville, Tennessee, United States, 37212-2637
        • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 70 years of age or older

  2. Eligible for ICD implementation according to the CMS criteria for primary prevention by one of the following conditions:

    1. Documented prior MI and a measured left ventricular ejection fraction (LVEF) <=30% (includes New York Heart Association [NYHA] class I, II, or III)
    2. Coronary artery disease with a documented prior MI, a measured left ventricular ejection fraction <=35%, and inducible, sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) at electrophysiology (EP) study
    3. Ischemic dilated cardiomyopathy (IDCM), documented prior MI, NYHA class II and III heart failure, and measured LVEF <=35%
    4. Non-ischemic dilated cardiomyopathy (NIDCM) > 3 months, NYHA Class II and III heart failure, and measured LVEF <=35%
  3. Stable condition on Optimal Medical Therapy
  4. Able and willing to provide informed consent to participate in this study

Exclusion Criteria:

  1. Enrolled in or planning to enroll in a conflicting trial
  2. Receiving a bi-ventricular ICD device
  3. New York Heart Association class IV heart failure
  4. Cardiogenic shock or symptomatic hypotension while in stable baseline rhythm,
  5. Coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past 3 months
  6. An MI within the past 40 days
  7. Clinical symptoms or findings that would make them a candidate for coronary revascularization
  8. Irreversible brain damage from pre-existing cerebral disease
  9. Any disease other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year
  10. Circumstance that would prevent completion of the trial and follow-up activities, including medical condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
ICD implantation in addition to Optimal Medical Therapy
Device: Implantable Cardioverter Defibrillator
The ICD and lead(s) will be FDA-approved.
Active Comparator: 2
Optimal Medical Therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Through study completion, starting from consent/baseline: average of 31 months.
All-cause mortality
Through study completion, starting from consent/baseline: average of 31 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life - Minnesota Living With Heart Failure Questionnaire
Time Frame: Measured at 12-months post-randomization
Minnesota Living with Heart Failure questionnaire. MLHF scoring: 0 points = Best QOL, 105 points = Worst QOL.
Measured at 12-months post-randomization
Sudden Cardiac Death
Time Frame: Through study completion, starting from consent/baseline: average of 31 months.
Sudden Cardiac Death
Through study completion, starting from consent/baseline: average of 31 months.
All-cause Hospitalization
Time Frame: Through study completion, starting from consent/baseline: average of 31 months.
Number of participants hospitalized during study follow-up
Through study completion, starting from consent/baseline: average of 31 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Study Chair: Steve Singh, MD, Washington DC VA Medical Center, Washington, DC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2015

Primary Completion (Actual)

November 6, 2020

Study Completion (Actual)

November 6, 2020

Study Registration Dates

First Submitted

April 16, 2014

First Submitted That Met QC Criteria

April 21, 2014

First Posted (Estimate)

April 23, 2014

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

December 21, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 592

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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