Pacing Techniques for Post-TAVR Heart Block

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines different pacing techniques for individuals with heart rhythm issues following transcatheter aortic valve replacement (TAVR). The researchers aim to determine whether pacing the heart using the left bundle branch area method (Left Bundle Branch Area Pacing, or LBBAP) improves heart function more than the traditional right ventricular pacing method (Right Ventricular Septal Pacing). Individuals who have undergone TAVR within the last four weeks and are receiving their first pacemaker due to heart rhythm problems, such as symptomatic bradycardia or high-grade atrioventricular block, might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance heart pacing techniques for future patients.

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 prior data suggests that these pacing techniques are safe for patients with post-TAVR heart block?

Research has shown that left bundle branch area pacing is generally safe and effective for patients needing a pacemaker after transcatheter aortic valve replacement (TAVR). Studies have found that it manages heart rhythm well without major problems. One study noted that patients had similar outcomes in the medium term compared to other methods, such as right ventricular pacing.

Right ventricular septal pacing is another common method, but it raises some concerns. Research indicates that if the heart relies heavily on the pacemaker, there might be a slight increase in the risk of readmission for heart failure. Despite this, it remains a widely used and well-understood method, and many patients do well with it.

In summary, both pacing methods have been used safely in TAVR patients. The choice between them often depends on the specific needs of the patient and the doctor's advice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the pacing techniques for post-TAVR heart block because they offer innovative ways to manage this condition. Unlike traditional right ventricular pacing, which can sometimes lead to reduced heart function over time, Left Bundle Branch Area Pacing aims to more naturally mimic the heart's electrical system, potentially preserving heart function better. Right Ventricular Septal Pacing is another promising method that targets a different area of the heart to optimize electrical conduction. By exploring these alternative pacing methods, researchers hope to improve outcomes and offer more tailored solutions for patients who undergo TAVR.

What evidence suggests that these pacing techniques could be effective for post-TAVR heart block?

This trial will compare two pacing techniques for patients experiencing heart block after transcatheter aortic valve replacement (TAVR). Research has shown that left bundle branch area pacing (LBBAP), which participants in Group A may receive, works well for patients needing assistance with their heart's electrical signals after TAVR. Studies have found that LBBAP can be used successfully and may lead to positive outcomes for these patients. In contrast, right ventricular septal pacing (RV pacing), which participants in Group B may receive, has been linked to worse outcomes when the heart relies heavily on the pacing. Some research suggests that reducing RV pacing or exploring alternative methods might benefit heart health. Overall, LBBAP appears to yield promising results, especially compared to traditional RV pacing, in maintaining heart function after TAVR. ^{1 3 4 6 7}

Who Is on the Research Team?

Ali Keramati, MD

Principal Investigator

Lankenau Heart Institute

Are You a Good Fit for This Trial?

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 had a TAVR procedure within the last four weeks.

Subject is receiving a first-time pacemaker implant

Subject is able to receive a left sided pectoral 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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 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]

Citations

1. jacc.org jacc.org/doi/10.1016/j.jaccas.2025.103274

Left Bundle Branch Area Pacing With TAVR We illustrate a successful case of left bundle branch area pacing with contemporary transcatheter aortic valve replacement.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11120400/

Feasibility and effectiveness of left bundle branch area ... The aim of our study was to assess the feasibility, success rates, and effectiveness of LBBAP in patients requiring pacing after TAVR.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589790X25005177

Left Bundle Branch Versus Apical Pacing in Atrioventricular ... Similar midterm outcomes were obtained with LBBP and RV pacing in an elderly population with high-degree AV block and preserved LVEF after TAVI.

4. heartrhythmopen.com heartrhythmopen.com/article/S2666-5018(24)00318-0/fulltext

A proposed algorithm for management of patients with left ... The study sought to assess the clinical outcomes of patients with post-TAVR conduction disorders managed according to a prespecified institutionally developed ...

5. mdpi.com mdpi.com/2673-1592/7/4/71

New-Onset Left Bundle Branch Block and Other ... New-onset LBBB is a frequent complication after TAVR and may negatively affect patient outcomes. Accurate risk stratification and standardised post-procedural ...

6. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(24)03318-6/abstract

Long-term outcomes of left bundle branch area pacing ... The purpose of this study was to investigate whether left bundle branch area pacing (LBBAP) improves long-term clinical results compared with ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/pace.70028?af=R

Left Bundle Branch Area Pacing After Transcatheter Aortic ... Permanent pacing after transcatheter aortic valve implantation (TAVI) causes higher rates of death, heart failure (HF) hospitalization and ...