Efficacy and Safety of ICD Implantation in the Elderly

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT02121158
First received: April 16, 2014
Last updated: October 21, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Cardiomyopathy
Coronary Artery Disease
Congestive Heart Failure
Myocardial Infarction
Device: Implantable Cardioverter Defibrillator
Other: Optimal standard of care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CSP #592 - Efficacy and Safety of ICD Implantation in the Elderly

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Regularly scheduled follow-up [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    To determine if a primary prevention strategy with ICD implantation in addition to optimal standard of care (OSC) is effective in reducing all-cause mortality compared to OSC alone in patients =70 years of age who are eligible for ICD therapy according to current Centers for Medicare & Medicaid Services (CMS) criteria.


Estimated Enrollment: 85
Study Start Date: February 2015
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
ICD implantation in addition to optimal standard of care
Device: Implantable Cardioverter Defibrillator

ICDs include:

  • INCEPTA ICD DR E 160 (Boston Scientific)
  • INCEPTA ICD VR E 163 (Boston Scientific)
  • PROTECTA XT VR D314VRG (Medtronic)
  • PROTECTA XT DR D314DRG (Medtronic)
Active Comparator: 2
Optimal standard of care
Other: Optimal standard of care
Guidance on lifestyle modification, exercise training, and disease management including review of AHA Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.

Detailed Description:

The overall aim of this trial is to study the safety and efficacy of ICD implantation as a primary prevention strategy of SCD in patients 70 years and older. In particular, this study is designed to determine the comparative effectiveness of ICD, in addition to the optimal standard of care (OSC), in reducing all-cause mortality, versus OSC alone; OSC includes standard intervention for chronic heart failure patients, i.e. lifestyle modification, disease management, adoption of healthy diet and exercise practices, et cetera. 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 + OSC or OSC alone, and stratified by participating site and co-morbidity level (Charlson score <3 versus 3). Acute treatment visits will occur as per site-specific conventions prior to the implantation, and within 1-4 months post-implantation; central follow-up will occur every 6 months thereafter, until study close. Neither the participant nor the 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 standard of care (OSC) is effective in reducing all-cause mortality compared to OSC 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 standard of care will reduce all-cause mortality in patients 70 years of age and older versus optimal standard of care 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 OSC versus ICD + OSC group.
  2. An additional secondary objective of the study is to determine the effect of ICD implantation plus optimal standard of care on QoL among elderly patients compared with optimal standard of care.
  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 70 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 LVEF 30% (includes NYHA class I, II, or III)
    • Coronary artery disease with a documented prior MI, a measured left ventricular ejection fraction 35%, and inducible, sustained VT or VF at EP study (The MI must have occurred more than 4 weeks prior to defibrillator insertion. The EP test must be performed more than 4 weeks after the qualifying MI)
    • 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%
  • Able and willing to provide informed consent to participate in this study

Exclusion Criteria:

  • Enrolled in or planning to enroll in another interventional 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02121158

Contacts
Contact: Michael Wininger, PhD (203) 932-5711 ext 3262 michael.wininger@va.gov
Contact: Jane Zhang, PhD (203) 932-5711 ext 3779 jane.zhang@va.gov

Locations
United States, California
VA Palo Alto Health Care System, Palo Alto, CA Not yet recruiting
Palo Alto, California, United States, 94304-1290
Contact: Minang (Mintu) Turakhia, MD    650-493-5000 ext 6689    minang.turakhia@va.gov   
United States, District of Columbia
Washington DC VA Medical Center, Washington, DC Not yet recruiting
Washington, District of Columbia, United States, 20422
Contact: Steve Singh, MD    202-745-8115    steve.singh@va.gov   
Study Chair: Steve Singh, MD         
United States, Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL Not yet recruiting
Gainesville, Florida, United States, 32608
Contact: Anthony Bavry, MD    352-376-1611 ext 6325    anthony.bavry@va.gov   
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN Not yet recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Selcuk Adabag, MD    612-467-3655    selcuk.adabag@va.gov   
United States, Oregon
Portland VA Medical Center, Portland, OR Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Karen MacMurdy, MD    503-220-8262    karen.macmurdy@va.gov   
United States, Tennessee
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN Not yet recruiting
Nashville, Tennessee, United States, 37212-2637
Contact: Jeffrey N Rottman, MD    615-873-7138    jeffrey.rottman@va.gov   
Sponsors and Collaborators
Investigators
Study Chair: Steve Singh, MD Washington DC VA Medical Center, Washington, DC
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT02121158     History of Changes
Other Study ID Numbers: 592
Study First Received: April 16, 2014
Last Updated: October 21, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
heart
coronary artery disease
congestive heart failure
myocardial infarction
CSP 592
ICD
cardiovascular
aging
chronic diseases
multi-site trial
phase 3
investigational device
cardiomyopathy

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Failure
Myocardial Infarction
Heart Diseases
Cardiomyopathies
Infarction
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014