Factors Associated With Response to Cardiac Resynchronization Therapy in Heart Failure Patients With Non-LBBB ECG Pattern

Running, not enrolling

Conditions studied: Cardiomyopathies, Heart Failure, Non-left Bundle Branch Block, Cardiac Resynchronization Therapy

In brief

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 guideline indicated therapy, posing a significant treatment challenge. However, non-LBBB patients with echocardiography response to CRT-D have better outcomes, and pre-implant variables could predict response, identifying patients who benefit the most. In this study, we plan to enroll 270 HF patients with non-LBBB and guideline-indicated CRT-D implantation to validate our prior echocardiography predictor score, and to identify novel ECG and echocardiography predictors using conventional statistics and machine learning analysis. We will also assess the applicability of such a score for clinical outcomes of HF, ventricular arrhythmias, or death.

Key facts

Study ID

NCT06977217

Run by

University of Rochester

People needed

270

Starts

2022-03-21

Expected to finish

2027-06-30

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Rochester Medical Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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