Left bundle branch area pacing with multimodal guidance vs. conventional pacing for heart failure with complete left bundle branch block

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized trial compares multimodal quantitative guidance for left bundle branch area pacing to conventional biventricular pacing in adults with non-ischemic cardiomyopathy, reduced ejection fraction, and complete left bundle branch block. Participants receive guideline-directed medical therapy and are followed to assess long-term outcomes. The study aims to determine if the multimodal approach improves pacing effectiveness and safety, addressing limitations of current single-center and non-randomized evidence. Lead placement is guided by a predefined multimodal data fusion system, with intraoperative and postoperative recording of pacing parameters. The trial seeks to establish whether this physiological pacing strategy can achieve superior cardiac synchrony and clinical endpoints.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-80 years;
* Sinus rhythm, complete left bundle branch block (LBBB) fulfilling the Strauss criteria (QRS duration \>140 ms in men or \>130 ms in women);
* Non-ischemic cardiomyopathy, left ventricular ejection fraction (LVEF) ≤40%, and New York Heart Association (NYHA) functional class II-IV;
* Signed informed consent.
* All enrolled patients received guideline-recommended pharmacological therapy for heart failure for at least 3 months.

Exclusion Criteria:

* Coronary CT-confirmed ischemic cardiomyopathy;
* wide QRS complex with non-LBBB morphology, including right bundle branch block and nonspecific intraventricular conduction block;
* persistent atrial fibrillation;
* pacemaker replacement without reimplantation of ventricular leads;
* patients with special conditions, such as pregnancy, gestation, and advanced malignancy.
* All patients underwent detailed recording of electrophysiological pacing parameters intraoperatively and postoperatively, and monitoring for surgical complications.

Where it's running

• Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, China.
  Nanchang, Jiangxi, China Recruiting

Study contacts

• Study coordinator: Zhenyu Zhai, PHD
• Email: 13337107502@163.com
• Phone: +86 15079109953

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.