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

Launched by FU WAI HOSPITAL, BEIJING, CHINA · Nov 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for heart failure called "early left bundle branch pacing," which may help improve heart function compared to standard medical treatments. The goal is to see if this pacing technique can better support patients who have mild to moderate heart failure and a specific heart condition known as left bundle branch block (LBBB). The trial is currently recruiting participants who are at least 18 years old, have been experiencing heart failure symptoms despite medication for at least three months, and have a certain level of heart function (ejection fraction between 35% and 50%).

If you or a loved one are considering participating, you would need to meet certain requirements, such as having symptomatic heart failure and not having severe heart disease that might require surgery soon. Participants will receive either the new pacing treatment or standard medication and will be monitored to see how well each approach works. It's important to know that individuals with certain severe heart issues or those who are pregnant cannot participate in this trial. This study hopes to provide new insights into improving heart failure treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years;
• • 2. symptomatic heart failure despite guideline-directed medical therapy for at least 3 months, NYHA class II-IV, with an EF between 35% and 50%;
• • 3. complete LBBB meeting Strauss's standard definition
• • 4. Signed informed consent.
• Exclusion Criteria:
• • 1. Expected survival less than 24 months;
• • 2. Indicated for ICD or pacing therapy;
• • 3. History of VT, VF, or hemodynamic instability;
• • 4. History of mechanical tricuspid valve replacement;
• • 5. Ischemic cardiomyopathy scheduled for CABG and PCI within 3 months;
• • 6. Severe structural heart disease may necessitate cardiac surgery or heart transplantation within 1 year;
• • 7. Pregnancy or planning for pregnancy;
• • 8. Hypertrophic cardiomyopathy or those underwent ventricular septal defect repair, in whom the success of LBBP is anticipated to be challenging;
• • 9. Severe renal dysfunction (eGFR \< 15ml/min\*1.73m\^2).