Status:
ACTIVE_NOT_RECRUITING
Factors Associated With Response to Cardiac Resynchronization Therapy in Heart Failure Patients With Non-LBBB ECG Pattern
Lead Sponsor:
University of Rochester
Conditions:
Cardiomyopathies
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
Cardiac resynchronization therapy with a defibrillator (CRT-D) in heart failure (HF) patients without left bundle branch block (non-LBBB) has been less beneficial to improve outcomes despite being a g...
Detailed Description
Morbidity, mortality, and health care costs of the treatment of systolic heart failure (HF) are rapidly increasing. Cardiac resynchronization therapy with a defibrillator (CRT-D) is cost-effectively r...
Eligibility Criteria
Inclusion
- Age 18 years or older (no upper limit)
- Optimal medical therapy for heart failure as established by current guidelines;
- Class IIa or IIb guideline-based indication for CRT-D in non-LBBB patients, including one of the following:
- New York Heart Association (NYHA) class II HF symptoms, LVEF ≤ 30% and QRS≥ 150 ms (IIb);
- NYHA class III-IVa HF, LVEF ≤ 35%, and QRS duration ≥ 150 ms (IIa);
- NYHA class III-IVa HF, LVEF ≤ 35%, and QRS duration 120- 149 ms (IIb)
- Successful CRT-D generator implant
Exclusion
- Unable to obtain imaging data from echocardiogram within 1 year prior to CRT-D implant
- Unable to obtain the 20-minute ECG prior to CRT-D implant
- Unable to enroll within 14 days following successful CRT-D generator implant
- Unable or unwilling to follow the study protocol
- Less than 24 months life expectancy at enrollment
- Pregnancy or planned pregnancy in the next 24 months
Key Trial Info
Start Date :
March 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT06977217
Start Date
March 21 2022
End Date
June 30 2026
Last Update
May 18 2025
Active Locations (1)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642