Active — Not RecruitingNot Applicable

Clinical Efficacy of Early Left Bundle Branch Pacing for Cardiac Resynchronization Therapy

China36 participantsStarted 2023-06-26

Plain-language summary

This is a two-center, prospective randomized controlled trial. The aim of this study is to compare the clinical efficacy of early left bundle branch pacing for cardiac resynchronization therapy and guideline-directed medical therapy in heart failure with mild-reduced ejection fraction.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years;
✓. symptomatic heart failure despite guideline-directed medical therapy for at least 3 months, NYHA class II-IV, with an EF between 35% and 50%;
✓. complete LBBB meeting Strauss's standard definition
✓. Signed informed consent.

Exclusion criteria

✕. Expected survival less than 24 months;
✕. Indicated for ICD or pacing therapy;
✕. History of VT, VF, or hemodynamic instability;
✕. History of mechanical tricuspid valve replacement;
✕. Ischemic cardiomyopathy scheduled for CABG and PCI within 3 months;
✕. Severe structural heart disease may necessitate cardiac surgery or heart transplantation within 1 year;
✕. Pregnancy or planning for pregnancy;
✕. Hypertrophic cardiomyopathy or those underwent ventricular septal defect repair, in whom the success of LBBP is anticipated to be challenging;

What they're measuring

ΔLVEF between baseline and 6-month follow-up

Timeframe: 6 months

Trial details

NCT IDNCT06126081

SponsorFu Wai Hospital, Beijing, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

View on ClinicalTrials.gov More Heart Failure trials