Pacing Techniques for Post-TAVR Heart Block

Recruiting at 3 trial locations

Overseen By Ali Keramati, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Main Line Health

Disqualifiers: Previous IPG, ICD, BiV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

46 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to investigate the superiority of chronic left bundle branch area pacing compared to traditional right ventricular (RV) septal pacing in patients with high-grade conduction disease after transcatheter aortic valve replacement (TAVR). In this investigator initiated, multicenter, prospective, double-blinded, crossover study, chronic left bundle branch area pacing will be compared to chronic right ventricular septal pacing using echocardiographic measures of left ventricular systolic function in patients with a high cumulative ventricular pacing burden after TAVR.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Left Bundle Branch Area Pacing (LBBAP) for Post-TAVR Heart Block?

Research suggests that Left Bundle Branch Area Pacing (LBBAP) can prevent pacing-induced heart problems over the long term and may be a better alternative to traditional right ventricular pacing. It is also considered a promising method for treating heart rhythm issues, as it aims to mimic the heart's natural electrical pathways. ^{1 2 3 4 5}

Is Left Bundle Branch Area Pacing (LBBAP) safe for humans?

Left Bundle Branch Area Pacing (LBBAP) is considered a safe and clinically feasible method for pacing, as reported in recent studies. However, most safety data come from relatively small studies, so more research is needed to confirm these findings. ^{1 3 4 6 7}

How is the treatment Left Bundle Branch Area Pacing different from other treatments for post-TAVR heart block?

Left Bundle Branch Area Pacing (LBBAP) is unique because it directly targets the heart's natural electrical system to restore normal heart rhythms, unlike traditional pacing methods that may not address the underlying electrical issues. This approach can prevent complications like heart failure and pacing-induced heart problems by ensuring more natural heart function. ^{1 2 8 9 10}

Research Team

Ali Keramati, MD

Principal Investigator

Lankenau Heart Institute

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

I had a TAVR procedure within the last four weeks.

Subject is receiving a first-time pacemaker implant

Exclusion Criteria

Subject has more than mild para-valvular regurgitation following TAVR implantation

I have had a heart transplant.

Subject is pregnant, or of childbearing potential and not on a reliable form of birth control

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo chronic left bundle branch area pacing and right ventricular septal pacing in a crossover design

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 months

Long-term follow-up

Participants are monitored for long-term safety outcomes

18 months

Treatment Details

Interventions

• Left Bundle Branch Area Pacing
• Right Ventricular Septal Pacing

Trial Overview 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.

Participant Groups

Group I: Group B Experimental Treatment 1 Intervention

Group II: Group A Experimental Treatment 1 Intervention

Left Bundle Branch Area Pacing is already approved in European Union, United States for the following indications:

Approved in European Union as LBBAP for:

• Heart failure
• Cardiac resynchronization therapy non-response
• Bradyarrhythmia

Approved in United States as LBBAP for:

• Heart failure
• Cardiac resynchronization therapy non-response
• Bradyarrhythmia

Who Is Running the Clinical Trial?

Main Line Health

Lead Sponsor

Trials

22

Recruited

6,900+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Sharpe-Strumia Research Foundation

Collaborator

Trials

8

Recruited

890+

Findings from Research

In a study of 151 patients with symptomatic bradycardia who received left bundle branch area pacing (LBBAP), none developed pacing-induced cardiomyopathy (PICM), indicating that LBBAP is a safe option for patients with preserved left ventricular ejection fraction (LVEF).

For patients with a baseline LVEF below 50%, LBBAP significantly improved heart function, with LVEF increasing from 41.4% to 45.6% and global longitudinal strain (GLS) improving from 12.9% to 15.5% over a median follow-up of 23 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left bundle branch area pacing prevents pacing induced cardiomyopathy in long-term observation. Bednarek, A., Kiełbasa, G., Moskal, P., et al.[2023]

In a study of 50 bradycardia patients receiving left bundle branch area pacing (LBBAP), the lead tip location significantly influenced left ventricular activation time (LVAT), with shorter LVAT observed when the lead tip was within 2 mm of the left ventricular blood pool.

Paced QRS duration (QRSd) remained consistent across different lead tip locations, indicating that LBBAP can achieve physiological pacing characteristics regardless of the precise lead placement within the interventricular septum.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computed tomography imaging-identified location and electrocardiographic characteristics of left bundle branch area pacing in bradycardia patients. Chen, K., Liu, X., Hou, X., et al.[2022]

A new method for selective left bundle branch pacing (LBBP) using continuous low output (2 V / 0.5 ms) was evaluated in 28 patients, showing a high rate of successful left bundle branch capture during the procedure.

The study found that an abrupt shortening of the stimulus-to-peak left ventricular activation time (S-peak LVAT) during low output pacing was highly sensitive (100%) for predicting effective pacing, indicating this method could enhance the safety and efficacy of LBBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the shortening of the stimulus-to-peak left ventricular activation time at continuous low output to confirm left bundle branch capture. Zhong, J., Zheng, N., Jiang, L.[2022]

A right-sided approach for left bundle branch area pacing (LBBAP) was successfully performed in a heart failure patient using a modified delivery sheath, demonstrating that LBBAP can be adapted for right-sided implantation.

This case highlights the feasibility of LBBAP in patients with anatomical challenges, such as a persistent left superior vena cava, and suggests that with proper modifications, effective pacing can be achieved with stable parameters in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Right-sided approach to left bundle branch area pacing combined with atrioventricular node ablation in a patient with persistent left superior vena cava and left bundle branch block: a case report. Prolič Kalinšek, T., Žižek, D.[2022]

In a study of 29 heart failure patients, left bundle branch pacing (LBBP) was found to significantly improve left ventricular activation speed and mechanical synchrony compared to left ventricular septal pacing (LVSP).

After an average follow-up of 17 months, patients in the LBBP group showed a greater improvement in left ventricular ejection fraction (LVEF) of 26% compared to just 6% in the LVSP group, indicating that LBBP is more effective for resynchronization in heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resynchronization effects and clinical outcomes during left bundle branch area pacing with and without conduction system capture. Zhang, W., Chen, L., Zhou, X., et al.[2023]

In a study comparing 39 patients with left bundle branch area pacing (LBBAP) to 42 patients with right ventricular septal pacing (RVSP), LBBAP was found to significantly reduce mechanical dyssynchrony, as indicated by smaller phase analysis parameters and regional wall motion analysis results.

LBBAP achieved similar phase and wall motion analysis parameters to those of healthy controls, suggesting it provides more physiological ventricular activation compared to RVSP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing cardiac mechanical dyssynchrony in left bundle branch area pacing and right ventricular septal pacing using myocardial perfusion scintigraphy in the acute phase of pacemaker implantation. Miyajima, K., Urushida, T., Tamura, T., et al.[2022]

In a large study of 2533 patients across 14 European centers, permanent left bundle branch area pacing (LBBAP) showed a high lead implantation success rate of 92.4% for bradyarrhythmia and 82.2% for heart failure, indicating its feasibility as a primary pacing technique.

The study reported a complication rate of 11.7%, with specific complications from the ventricular transseptal route occurring in 8.3% of patients, suggesting that while LBBAP is promising, safety and success rates in heart failure patients need further improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left bundle branch area pacing outcomes: the multicentre European MELOS study. Jastrzębski, M., Kiełbasa, G., Cano, O., et al.[2022]

Left bundle branch area pacing (LBBAP) using stylet-driven leads (SDLs) without a sheath was successfully performed in 23 out of 25 patients (92% success rate), demonstrating its feasibility and safety for treating bradycardia.

The pacing characteristics, including QRS duration and pacing thresholds, were comparable between SDL-LBBAP and lumen-less leads (LLLs), while showing significant advantages over right ventricular septal pacing (RVSP), indicating that SDLs could be a viable alternative to LLLs in LBBAP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary experience of permanent left bundle branch area pacing using stylet-directed pacing lead without delivery sheath. Sun, Y., Yao, X., Zhou, X., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Left bundle branch area pacing prevents pacing induced cardiomyopathy in long-term observation. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Computed tomography imaging-identified location and electrocardiographic characteristics of left bundle branch area pacing in bradycardia patients. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the shortening of the stimulus-to-peak left ventricular activation time at continuous low output to confirm left bundle branch capture. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Right-sided approach to left bundle branch area pacing combined with atrioventricular node ablation in a patient with persistent left superior vena cava and left bundle branch block: a case report. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Resynchronization effects and clinical outcomes during left bundle branch area pacing with and without conduction system capture. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Assessing cardiac mechanical dyssynchrony in left bundle branch area pacing and right ventricular septal pacing using myocardial perfusion scintigraphy in the acute phase of pacemaker implantation. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Left bundle branch area pacing outcomes: the multicentre European MELOS study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Diverse QRS morphology reflecting variations in lead placement for left bundle branch area pacing. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Rapid reversal of heart failure by correcting left bundle branch block induced by transcatheter aortic valve replacement. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Preliminary experience of permanent left bundle branch area pacing using stylet-directed pacing lead without delivery sheath. [2022]