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Pacing

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

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
Adverse events related to device function
Nesiritide
Functional capacity measured using the New York Heart Association functional classification (NYHA)
+14 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group BExperimental Treatment1 Intervention
Group II: Group AExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Main Line HealthLead Sponsor
21 Previous Clinical Trials
6,843 Total Patients Enrolled
MedtronicIndustry Sponsor
611 Previous Clinical Trials
828,843 Total Patients Enrolled
3 Trials studying Atrioventricular Block
530 Patients Enrolled for Atrioventricular Block
Sharpe-Strumia Research FoundationOTHER
7 Previous Clinical Trials
843 Total Patients Enrolled

Media Library

Left Bundle Branch Area Pacing (Pacing) Clinical Trial Eligibility Overview. Trial Name: NCT05541679 — N/A
Atrioventricular Block Research Study Groups: Group A, Group B
Atrioventricular Block Clinical Trial 2023: Left Bundle Branch Area Pacing Highlights & Side Effects. Trial Name: NCT05541679 — N/A
Left Bundle Branch Area Pacing (Pacing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05541679 — N/A
~22 spots leftby Dec 2025
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