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

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ClinicalTrials.gov Identifier: NCT02121158
Recruitment Status : Recruiting
First Posted : April 23, 2014
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE April 16, 2014
First Posted Date  ICMJE April 23, 2014
Last Update Posted Date August 19, 2019
Actual Study Start Date  ICMJE August 7, 2015
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 21, 2014)
Regularly scheduled follow-up [ Time Frame: Up to 12 months ]
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.
Change History Complete list of historical versions of study NCT02121158 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the Elderly
Official Title  ICMJE CSP #592 - Efficacy and Safety of ICD Implantation in the Elderly
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiomyopathy
  • Coronary Artery Disease
  • Congestive Heart Failure
  • Myocardial Infarction
Intervention  ICMJE
  • Device: Implantable Cardioverter Defibrillator
    The ICD and lead(s) will be FDA-approved.
  • 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.
Study Arms  ICMJE
  • 1
    ICD implantation in addition to Optimal Medical Therapy
    Intervention: Device: Implantable Cardioverter Defibrillator
  • Active Comparator: 2
    Optimal Medical Therapy
    Intervention: Other: Optimal Medical Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 14, 2015)
100
Original Estimated Enrollment  ICMJE
 (submitted: April 21, 2014)
250
Estimated Study Completion Date  ICMJE August 1, 2021
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael T Wininger, PhD (203) 932-5711 ext 3262 michael.wininger@va.gov
Contact: Jane Zhang, PhD (203) 932-5711 ext 3779 jane.zhang@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02121158
Other Study ID Numbers  ICMJE 592
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Steve Singh, MD Washington DC VA Medical Center, Washington, DC
PRS Account VA Office of Research and Development
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP