Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the Elderly (I-70)
|Cardiomyopathy Coronary Artery Disease Congestive Heart Failure Myocardial Infarction||Device: Implantable Cardioverter Defibrillator Other: Optimal Medical Therapy|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||CSP #592 - Efficacy and Safety of ICD Implantation in the Elderly|
- 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.
|Actual Study Start Date:||August 7, 2015|
|Estimated Study Completion Date:||August 1, 2019|
|Estimated Primary Completion Date:||August 1, 2018 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02121158
|Contact: Michael T Wininger, PhD||(203) 932-5711 ext firstname.lastname@example.org|
|Contact: Jane Zhang, PhD||(203) 932-5711 ext email@example.com|
|United States, California|
|VA Palo Alto Health Care System, Palo Alto, CA||Withdrawn|
|Palo Alto, California, United States, 94304-1290|
|United States, District of Columbia|
|Washington DC VA Medical Center, Washington, DC||Recruiting|
|Washington, D.C., District of Columbia, United States, 20422|
|Contact: Steve Singh, MD 202-745-8115 firstname.lastname@example.org|
|Contact: Suzanne McNicholas (202) 745-5223 email@example.com|
|Study Chair: Steve Singh, MD|
|United States, Florida|
|North Florida/South Georgia Veterans Health System, Gainesville, FL||Recruiting|
|Gainesville, Florida, United States, 32608|
|Contact: Mark E Panna, Jr., MD 352-271-5000 ext 5105 firstname.lastname@example.org|
|United States, Minnesota|
|Minneapolis VA Health Care System, Minneapolis, MN||Recruiting|
|Minneapolis, Minnesota, United States, 55417|
|Contact: Selcuk Adabag, MD 612-467-3655 email@example.com|
|United States, Oregon|
|VA Portland Health Care System, Portland, OR||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Karen MacMurdy, MD 503-220-8262 firstname.lastname@example.org|
|United States, Tennessee|
|Tennessee Valley Healthcare System Nashville Campus, Nashville, TN||Recruiting|
|Nashville, Tennessee, United States, 37212-2637|
|Contact: Pablo Saavedra, MD 615-873-6940 email@example.com|
|Study Chair:||Steve Singh, MD||Washington DC VA Medical Center, Washington, DC|