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

NCT02121158 | Terminated Results DMC FDA Device

• 1 other identifier: 592
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 5

Brief 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

Cardiomyopathy; Coronary Artery Disease; Congestive Heart Failure; Myocardial Infarction

Keywords

CSP 592; ICD; cardiovascular; heart; aging; chronic diseases; multi-site trial; investigational device; cardiomyopathy; coronary artery disease; congestive heart failure; myocardial infarction; I-70; I70; elderly; defibrillator

Outcome Measures

Primary Outcomes (1)

• Mortality

  All-cause mortality

  Through study completion, starting from consent/baseline: average of 31 months.

Secondary Outcomes (3)

• Quality of Life - Minnesota Living With Heart Failure Questionnaire

  Measured at 12-months post-randomization

• Sudden Cardiac Death

  Through study completion, starting from consent/baseline: average of 31 months.

• All-cause Hospitalization

  Through study completion, starting from consent/baseline: average of 31 months.

Study Arms (2)

1

OTHER

ICD implantation in addition to Optimal Medical Therapy

Device: Implantable Cardioverter Defibrillator

2

ACTIVE COMPARATOR

Optimal Medical Therapy

Other: Optimal Medical Therapy

Interventions

Implantable Cardioverter Defibrillator DEVICE

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

1

Optimal Medical Therapy OTHER

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.

2

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years of age or older
• Eligible for ICD implementation according to the CMS criteria for primary prevention by one of the following conditions:
• Documented prior MI and a measured left ventricular ejection fraction (LVEF) \<=30% (includes New York Heart Association \[NYHA\] class I, II, or III)
• 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
• Ischemic dilated cardiomyopathy (IDCM), documented prior MI, NYHA class II and III heart failure, and measured LVEF \<=35%
• Non-ischemic dilated cardiomyopathy (NIDCM) \> 3 months, NYHA Class II and III heart failure, and measured LVEF \<=35%
• Stable condition on Optimal Medical Therapy
• Able and willing to provide informed consent to participate in this study

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (5)

Washington DC VA Medical Center, Washington, DC

Washington D.C., District of Columbia, 20422-0001, United States

Location

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, 37212-2637, United States

Location

Related Publications (1)

• Singh SN, Wininger M, Raitt M, Adabag S, Moore H, Rottman JN, Scrymgeour A, Zhang J, Zheng K, Guarino P, Kyriakides TC; I-70 Study Group; Johnson G, Williams A, Beed A, MacMurdy K, Saavedra P. Efficacy and safety of implantable cardioverter-defibrillator implantation in the elderly-The I-70 Study: A randomized clinical trial. Heart Rhythm O2. 2024 Apr 27;5(6):365-373. doi: 10.1016/j.hroo.2024.04.010. eCollection 2024 Jun.

  PMID: 38984364 RESULT

MeSH Terms

Conditions

Cardiomyopathies; Coronary Artery Disease; Heart Failure; Myocardial Infarction; Chronic Disease

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Disease Attributes

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Results Point of Contact

• Title: Michael T. Wininger, Ph.D., Study Biostatistician
• Organization: VA Cooperative Studies Program Coordinating Center, West Haven, CT

michael.wininger@va.gov

203-932-5711

Study Officials

• Steve Singh, MD

  Washington DC VA Medical Center, Washington, DC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 23, 2014
• Study Start: August 7, 2015
• Primary Completion: November 6, 2020
• Study Completion: November 6, 2020
• Last Updated: July 31, 2024
• Results First Posted: January 20, 2022

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)