Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the Elderly (I-70)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02121158|
Recruitment Status : Active, not recruiting
First Posted : April 23, 2014
Last Update Posted : June 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cardiomyopathy Coronary Artery Disease Congestive Heart Failure Myocardial Infarction||Device: Implantable Cardioverter Defibrillator Other: Optimal Medical Therapy||Not Applicable|
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.
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.
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.
- 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.
- 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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||CSP #592 - Efficacy and Safety of ICD Implantation in the Elderly|
|Actual Study Start Date :||August 7, 2015|
|Actual Primary Completion Date :||November 6, 2020|
|Estimated Study Completion Date :||November 6, 2021|
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.
- All-cause mortality [ Time Frame: Up to 24 months ]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 who are eligible for ICD therapy according to current Centers for Medicare & Medicaid Services (CMS) criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02121158
|United States, District of Columbia|
|Washington DC VA Medical Center, Washington, DC|
|Washington, District of Columbia, United States, 20422|
|United States, Florida|
|North Florida/South Georgia Veterans Health System, Gainesville, FL|
|Gainesville, Florida, United States, 32608|
|United States, Minnesota|
|Minneapolis VA Health Care System, Minneapolis, MN|
|Minneapolis, Minnesota, United States, 55417|
|United States, Oregon|
|VA Portland Health Care System, Portland, OR|
|Portland, Oregon, United States, 97239|
|United States, Tennessee|
|Tennessee Valley Healthcare System Nashville Campus, Nashville, TN|
|Nashville, Tennessee, United States, 37212-2637|
|Study Chair:||Steve Singh, MD||Washington DC VA Medical Center, Washington, DC|