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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

Study 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 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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Main Line HealthLead Sponsor

20 Previous Clinical Trials

6,733 Total Patients Enrolled

MedtronicIndustry Sponsor

606 Previous Clinical Trials

828,619 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are the focus of this research study?

"Affirmative. Records hosted on clinicaltrials.gov suggest that this investigation is still recruiting participants, having first been posted on December 28th 2022 and last modified on January 20th 2021. The trial requires 46 patients from a single site to complete it's objectives."

Answered by AI

Are participants being currently accepted for this clinical research effort?

"As reported on clinicaltrials.gov, this investigation is actively recruiting patients and was initially posted on December 28th 2022 with an update made to the study details on January 20th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparison of Left Bundle Branch Area Versus Right Ventricular Septal Pacing in Patients With High-degree Conduction Disease After Transcatheter Aortic Valve Replacement (Left Bundle BRAVE)

2022. "Comparison of Left Bundle Branch Area Versus Right Ventricular Septal Pacing in Patients With High-degree Conduction Disease After Transcatheter Aortic Valve Replacement (Left Bundle BRAVE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05541679.

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