Cardiac Resynchronization in the Elderly
![]() |
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: NCT03031847 |
Recruitment Status :
Completed
First Posted : January 26, 2017
Last Update Posted : June 16, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure | Device: Cardiac Resynchronization Therapy Pacemaker Device: Cardiac Resynchronization Therapy Defibrillator | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 102 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized, open-label, controlled trial of CRT-P vs. CRT-D in HF patients (age ≥ 75 years) |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Cardiac Resynchronization in the Elderly: Piloting Pacemaker vs. Defibrillator Therapy (Randomized Trial) |
Actual Study Start Date : | March 21, 2017 |
Actual Primary Completion Date : | August 18, 2021 |
Actual Study Completion Date : | August 18, 2021 |
Arm | Intervention/treatment |
---|---|
Randomized- Pacemaker (CRT-P)
Cardiac resynchronization therapy Pacemaker
|
Device: Cardiac Resynchronization Therapy Pacemaker
Patients randomized to the pacemaker arm will receive a CRT-P device.
Other Name: CRT-P |
Randomized- Defibrillator (CRT-D)
Cardiac resynchronization therapy Defibrillator
|
Device: Cardiac Resynchronization Therapy Defibrillator
Patients randomized to the defibrillator arm will receive a CRT-D device.
Other Name: CRT-D |
Observational- Pacemaker (CRT-P)
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
Patients randomized to the pacemaker arm will receive a CRT-P device.
Other Name: CRT-P |
Observational- Defibrillator (CRT-D)
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
Patients randomized to the defibrillator arm will receive a CRT-D device.
Other Name: CRT-D |
- Enrollment [ Time Frame: At 1 year after start of the study ]Rates of enrollment of participants in this randomized trial
- QOL [ Time Frame: At 6 months after enrollment ]Quality of life of CRT-P versus CRT-D recipients using Minnesota Living with Heart Failure Questionnaires
- QOL2 [ Time Frame: At 6 months after enrollment ]QOL of CRT-P versus CRT-D recipients using RAND-36
- Retention [ Time Frame: At 6 months after enrollment ]Rates of retention of participants in this randomized trial

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, Learn About Clinical Studies.
Ages Eligible for Study: | 75 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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): NCT03031847
United States, North Carolina | |
Duke University Health System | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
The Ohio State University | |
Columbus, Ohio, United States, 43210 | |
United States, Pennsylvania | |
UPMC Hamot | |
Erie, Pennsylvania, United States, 16550 | |
UPMC | |
Pittsburgh, Pennsylvania, United States, 15213 | |
Veterans Research Foundation of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15240 | |
UPMC Pinnacle | |
Wormleysburg, Pennsylvania, United States, 17043 |
Principal Investigator: | Samir Saba, MD | University of Pittsburgh |
Responsible Party: | Samir Saba, Associate Professor <Me; Associate Chief of Cardiology; Director of Cardiovascular Electrophysiology;, University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT03031847 |
Other Study ID Numbers: |
PRO17010015 |
First Posted: | January 26, 2017 Key Record Dates |
Last Update Posted: | June 16, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Heart Failure Heart Diseases Cardiovascular Diseases |