Cardiac Resynchronization in the Elderly

Study Overview
=================
Brief Summary
-----------------
This pilot will enroll 50 HF patients (age ≥ 75 years) undergoing CRT device implantation at the hospitals of the University of Pittsburgh Medical Center, Duke University, Ohio State University, and the VA Pittsburgh Healthcare System. Patients will be randomized to CRT-P versus CRT-D and followed until study end. Rates of patient screening, enrollment, randomization, and retention as well as cost of care will be examined. The results of this pilot study will inform the design of a large pivotal non-inferiority trial and will be necessary for its success. Patients who refuse participation in the randomized pilot trial will be asked to enroll in a prospective observational cohort. Characteristics of patients who choose CRT-P vs. CRT-D will be compared and patients' level of satisfaction with their device decision will be measured.

Detailed Description
-----------------
The goal of this study is to pilot test a randomized, controlled, non-inferiority trial comparing the survival and quality of life (QOL) of older patients receiving cardiac resynchronization therapy (CRT) pacemaker (CRT-P) versus defibrillator (CRT-D) therapy. This pilot will enroll 50 HF patients (age ≥ 75 years) undergoing CRT device implantation at the hospitals of the University of Pittsburgh Medical Center, Duke University, Ohio State University, and the VA Pittsburgh Healthcare System. Patients will be randomized to CRT-P versus CRT-D and followed until study end. Rates of patient screening, enrollment, randomization, and retention as well as cost of care will be examined. The results of this pilot study will inform the design of a large pivotal non-inferiority trial and will be necessary for its success. Patients who refuse participation in the randomized pilot trial will be enrolled and followed as part of a prospective observational cohort. Characteristics of patients who choose CRT-P vs. CRT-D will be compared and patients' level of satisfaction with their device decision will be measured.

Official Title
-----------------
Cardiac Resynchronization in the Elderly: Piloting Pacemaker vs. Defibrillator Therapy (Randomized Trial)

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Cardiac Resynchronization Therapy Pacemaker
* Device: Cardiac Resynchronization Therapy Defibrillator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >/= 75 years Left Ventricular Ejection Fraction (LVEF) ≤ 35% by cardiac imaging including echocardiogram, nuclear imaging, cardiac catheterization, or cardiac magnetic resonance imaging QRS width >120 ms on surface electrocardiogram New York Heart Association class II, III, or ambulatory IV for Heart Failure (HF) Patient undergoing de novo CRT device implantation of CRT-D device change-out for battery depletion Exclusion Criteria: Patient within 40 days of acute myocardial infarction Patient within 3 months of cardiac revascularization (percutaneous coronary intervention or bypass surgery) Patient with prior history of cardiac arrest or documented sustained ventricular arrhythmia Patient with expected longevity < 1 year Patient not on optimal medical therapy for HF management including when tolerated β-blockers, angiotensin converting enzyme inhibitors or angiotensin receptor blockers Patient not planning to have his/her follow-up at participating institution Patient unable or unwilling to sign a written informed consent Patient's with dementia that are unable to consent for themselves Participating in any other clinical trials (observational/registries allowed)

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, open-label, controlled trial of CRT-P vs. CRT-D in HF patients (age ≥ 75 years)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Randomized- Pacemaker (CRT-P)<br>Cardiac resynchronization therapy Pacemaker | Device: Cardiac Resynchronization Therapy Pacemaker<br>* Patients randomized to the pacemaker arm will receive a CRT-P device.<br>* Other names: CRT-P;|
| Other: Randomized- Defibrillator (CRT-D)<br>Cardiac resynchronization therapy Defibrillator | Device: Cardiac Resynchronization Therapy Defibrillator<br>* Patients randomized to the defibrillator arm will receive a CRT-D device.<br>* Other names: CRT-D;|
| Other: Observational- Pacemaker (CRT-P)<br>Cardiac resynchronization therapy Pacemaker (CRT-P): Patients in this arm declined randomization in the trial and elected to participate in the observational registry | Device: Cardiac Resynchronization Therapy Pacemaker<br>* Patients randomized to the pacemaker arm will receive a CRT-P device.<br>* Other names: CRT-P;|
| Other: Observational- Defibrillator (CRT-D)<br>Cardiac resynchronization therapy Defibrillator (CRT-D): Patients in this arm declined randomization in the trial and elected to participate in the observational registry | Device: Cardiac Resynchronization Therapy Defibrillator<br>* Patients randomized to the defibrillator arm will receive a CRT-D device.<br>* Other names: CRT-D;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment | Rates of enrollment of participants in this randomized trial | At 1 year after start of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QOL | Quality of life of CRT-P versus CRT-D recipients using Minnesota Living with Heart Failure Questionnaires. The Minnesota Living with Heart Failure scale ranges from 0 to 105, in which a lower score indicates a better outcome. The Minnesota Living with Heart Failure Physical subscale ranges from 0 to 40 and the Minnesota Living with Heart Failure Mental subscale ranges from 0 to 25. Lower scores on the subscales indicate a better outcome. | At 6 months after enrollment | 
| QOL2 | QOL of CRT-P versus CRT-D recipients using RAND-36. The RAND-36 is a normalized scale with a range of 0 to 100, in which a higher score is indicative of a better outcome. PCS-T and MCS-T are the two summary components of the RAND-36. The subscales PCS-T and MCS-T are both normalized with a range of 0 to 100. Higher scores on the subscales indicate a better outcome. | At 6 months after enrollment | 
| Retention | Rates of retention of participants in this randomized trial | At 6 months after enrollment | 
| Health Care Cost | Cost of health care between CRT-P and CRT-D recipients. | At 6 months after enrollment |