NCT06977217Active, not recruiting
Factors Associated With Response to Cardiac Resynchronization Therapy in Heart Failure Patients With Non-LBBB ECG Pattern
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 270 (actual)
- First submitted
- 8 May 2025
- Start date
- 21 Mar 2022
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- University of Rochester
- Diseases
- Heart failure
- NCT number
- NCT06977217
What you commit to
- Study type: Observational
- Participants enrolled: 270
- From 21 Mar 2022 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.