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CRT-P vs CRT-D for Cardiac Resynchronization - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about randomizing older adult (over age 75) heart failure patients to CRT-P vs. CRT-D, both approved therapies for the heart failure. What we learn from this pilot study will help with the future design of a larger randomized trial comparing the effect of these two therapies on patient outcomes.
What is the Condition Being Studied?
Heart failure in patients over age 75 who need a pacemaker or internal defibrillator

Who Can Participate in the Study?

Adults over age 75 who are referred for a Cardiovascular Resynchronization Device who:
- Have not had a heart attack within the last 40 days
- Are within 3 months of previous cardiac revascularization (bypass surgery or percutaneous intervention (for instance, angioplasty))

Age Group

What is Involved?

If you choose to join this study, you will:

- Be asked to complete questionnaires and surveys, which may take up to 40 minutes.  
- Be randomized (like the flip of a coin) to receive a cardiac resynchronization therapy pacemaker (CRT-P) or defibrillator (CRT-D) device.  
- Receive a phone call from the study team about 30 days after the procedure ask about how you have been doing since the procedure and whether you had any complications.  
- Receive follow-up phone calls 3 and 6 months after the procedure, and every 6 months until the end of the study  
-- The 6-month contact might be a phone call or a clinic visit  

Study Details

Full Title
Cardiac Resynchronization in the Elderly: Piloting Pacemaker vs. Defibrillator Therapy (Randomized Trial and Observational)
Principal Investigator
Protocol Number
IRB: PRO00083431
NCT: NCT03031847
Phase N/A
Contact the Duke Recruitment Innovation Center