Pacing Techniques for Post-TAVR Heart Block

N/A

Recruiting

Led By Ali Keramati, MD

Research Sponsored by Main Line Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if switching to left bundle branch pacing can improve heart function better than traditional RV pacing after TAVR.

Who is the study for?

This trial is for adults over 18 who've had a transcatheter aortic valve replacement (TAVR) in the last two weeks, have high-grade heart block or cardiomyopathy but still have an ejection fraction over 50%. They must be getting their first pacemaker and not need more complex devices like biventricular pacers. Pregnant women, those with mechanical heart valves, previous heart transplants, or life expectancy under two years are excluded.

What is being tested?

The study compares two types of pacemaker placements after TAVR: one group gets left bundle branch area pacing first then switches to right ventricular septal pacing; the other does this in reverse order. The goal is to see which method better supports heart function using ultrasound measures of how well the left ventricle pumps blood.

What are the potential side effects?

While specific side effects aren't listed here, generally speaking, potential risks from pacemaker implantation can include infection at the implant site, bleeding or bruising, lead displacement causing poor pacing function or need for reoperation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in global longitudinal strain (GLS%)

Change in left ventricular ejection fraction (LVEF%)

Composite of left bundle branch area pacing lead septal myocardial or coronary artery perforation, lead dislodgment, and repeat procedures related to left bundle branch area lead implantation