Leadless Pacemakers vs. Left Bundle Area Pacing for Heart Block

(COMPAREPACE Trial)

Recruiting at 1 trial location

Overseen By Kathy Byrd, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH

Disqualifiers: Atrial fibrillation, Renal disease, Dementia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of pacemakers for individuals with heart block: leadless pacemakers (including the Micra Transcatheter Pacing System, Aveir VR Leadless Pacemaker, and Aveir DR Leadless Pacemaker System) and left bundle area pacing. Researchers aim to determine which option is safer and more effective. The trial is suitable for adults requiring a permanent pacemaker due to specific heart conditions, such as AV node disease or following certain heart procedures like TAVR. Participants should generally maintain healthy heart function and adhere to the trial's guidelines. As an unphased trial, this study provides a unique opportunity to contribute to medical advancements and improve future treatment options.

Do I need to stop my current medications for the trial?

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that leadless pacemakers, such as the Micra, have a low rate of major complications over five years. Patients with these pacemakers experienced fewer problems than those with traditional pacemakers, which use wires to connect to the heart. This suggests that leadless pacemakers are safe and well-tolerated.

For left bundle area pacing (LBBP), studies have shown promising results for safety and effectiveness. LBBP may reduce the risk of certain heart issues compared to traditional right ventricular pacing. Reports indicate it is safe, with fewer cases of pacing-related heart failure.

Both treatments appear safe based on current research. Prospective trial participants may find this information reassuring regarding the safety of these options. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for heart block because they offer innovative approaches compared to traditional pacemakers. Leadless pacemakers, like the MICRA AV, eliminate the need for leads, reducing complications associated with lead placement and long-term maintenance. On the other hand, left bundle area pacing targets a specific area of the heart for electrical stimulation, which can improve heart function more naturally compared to traditional right ventricular pacing. These advancements have the potential to enhance patient comfort and outcomes significantly.

What evidence suggests that this trial's treatments could be effective for heart block?

This trial will compare leadless pacemakers with left bundle area pacing for treating heart block. Studies have shown that leadless pacemakers, such as the Micra AV, effectively address heart rhythm problems with fewer complications and follow-up procedures than traditional pacemakers. Specifically, the Micra AV leadless pacemaker has been successfully implanted in many patients with few major issues over a year. Meanwhile, left bundle area pacing, which stimulates a specific part of the heart, has also proven safe and effective. Research indicates it can improve heart function, particularly for patients who might encounter issues with traditional pacemakers. Both treatments in this trial offer promising results for managing heart block conditions, providing patients with safer and effective options. ^{5 6 7 8 9}

Who Is on the Research Team?

Dinesh Sharma, MD

Principal Investigator

NCH Healthcare

Are You a Good Fit for This Trial?

This trial is for individuals who require a pacemaker due to heart block and are eligible for the procedure. Specific eligibility details are not provided, but typically participants must meet certain health criteria.

Inclusion Criteria

Life expectancy > 1 year

Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements

Subject has been informed of the nature of the study, agrees to its provision and has provided written informed consent, approved by the IRB

Exclusion Criteria

Sinus node dysfunction, anticipating atrial pacing or atrial fibrillation

I have had surgery on my heart valves.

I am able to understand and give consent for my treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a leadless pacemaker or left bundle area pacing

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Leadless Pacemakers
• Left Bundle Area Pacing

Trial Overview The study compares two types of pacemakers: leadless pacemakers versus left bundle area pacing. It's a randomized controlled trial, meaning patients are randomly assigned to one of the two groups in equal numbers.

How Is the Trial Designed?

Group I: Left bundle area pacing Active Control 1 Intervention

Transvenous pacemaker with left bundle area pacing

Group II: MICRA AV Active Control 1 Intervention

Transcatheter pacemaker with MICRA AV

Leadless Pacemakers is already approved in United States, European Union for the following indications:

Approved in United States as Micra Transcatheter Pacing System for:

• Symptomatic paroxysmal or permanent high-grade AV block in the presence of atrial fibrillation

Approved in United States as Aveir VR Leadless Pacemaker for:

• Bradycardia with normal sinus rhythm with only rare episodes of A-V block or sinus arrest
• Chronic atrial fibrillation
• Severe physical disability

Approved in United States as Aveir DR Leadless Pacemaker System for:

• Management of one or more of the following permanent conditions: syncope, pre-syncope, fatigue, disorientation

Approved in European Union as Aveir DR Leadless Pacemaker System for:

• Abnormal or slow heart rhythms

Who Is Running the Clinical Trial?

NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH

Lead Sponsor

Trials

2

Recruited

240+

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

Published Research Related to This Trial

The WiSE-CRT system successfully demonstrated the technical feasibility of leadless left bundle branch area pacing (LBBAP) in two patients, showing effective electrical resynchronization and hemodynamic response, which is crucial for treating heart conditions like complete heart block.

Leadless CRT offers a promising alternative for patients with complications from traditional leads, potentially improving treatment options for those with venous access issues, although further studies are needed to evaluate its long-term safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical feasibility of leadless left bundle branch area pacing for cardiac resynchronization: a case series. Elliott, MK., Jacon, P., Sidhu, BS., et al.[2022]

In a study of 21 patients with heart failure and left bundle branch block, left bundle branch pacing (LBBP) showed greater improvements in electrical and mechanical synchrony compared to biventricular pacing (BVP), including a significant reduction in QRS duration and area.

LBBP also resulted in a higher increase in hemodynamic performance, as measured by the maximum rate of left ventricular pressure rise (dP/dtmax), indicating it may be a more effective option for cardiac resynchronization therapy in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left Bundle Branch Pacing Versus Biventricular Pacing for Acute Cardiac Resynchronization in Patients With Heart Failure. Liang, Y., Wang, J., Gong, X., et al.[2022]

This case study highlights the successful implantation of a leadless Micra pacemaker in a patient with a durable left ventricular assist device (LVAD) who was dependent on pacing due to infection of a traditional transvenous pacemaker.

The findings suggest that leadless pacemakers may be a safe and effective alternative for LVAD patients, although more research is needed to fully understand their efficacy in this specific population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leadless pacemaker use in a patient with a durable left ventricular assist device. Parker, AM., Vilaro, JR., Aranda, JM., et al.[2021]

In a study of 11 patients undergoing left bundle area pacing (LBAP), same-day discharge was found to be safe, with no procedure-related complications reported, and an average discharge time of 5.6 hours post-procedure.

Pacemaker parameters remained stable after 6 months of follow-up, suggesting that LBAP is not only safe for same-day discharge but also effective in maintaining pacing function over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Same-Day Discharge After Left Bundle Area Pacing. Kadado, AJ., Gobeil, K., Pervaiz, A., et al.[2023]

The Aveir VR Leadless Pacemaker has been recently approved by the FDA and offers design improvements over previous leadless pacemakers, such as the Nanostim, enhancing its functionality and safety.

Understanding the unique features of the Aveir VR is crucial for anesthesiologists during preoperative management, as it differs significantly from other leadless devices like the Micra, necessitating tailored approaches in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aveir Leadless Pacemaker: Novel Technology With New Anesthetic Implications. Tang, JE., Savona, SJ., Essandoh, MK.[2023]

Leadless cardiac pacemakers, like the Micra™ system, are a safe alternative to traditional pacemakers but can still have complications, including serious ones like cardiac tamponade and high capture thresholds.

A rare case of ventricular fibrillation arrest occurred after the implantation of a Micra™ leadless pacemaker, highlighting the potential risks associated with this technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ventricular Fibrillation Cardiopulmonary Arrest Following Micra™ Leadless Pacemaker Implantation. Ahmad, H., Brar, V., Butt, N., et al.[2021]

The Aveir™ VR leadless pacemaker showed longer projected longevity (18.8 years) compared to the Micra™ VR pacemaker (7.7 years), indicating it may provide a more durable solution for patients needing pacing support.

While the Aveir™ VR required longer implantation and fluoroscopic times, both devices had low complication rates, suggesting that safety is maintained across both types of leadless pacemakers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implant efficiency and clinical performance of Aveir™ VR and Micra™ VR leadless pacemaker: A multicenter comparative analysis of 67 patients. Tokavanich, N., Machado, C., Banga, S., et al.[2023]

In a study of 83 patients undergoing left bundle branch area pacing (LBBP), both stylet-driven and lumenless lead delivery systems achieved similar success rates (77% overall), indicating that both methods are effective for this procedure.

The stylet-driven lead delivery system resulted in significantly shorter procedure and fluoroscopy times compared to the lumenless system, suggesting it may be more efficient while maintaining comparable safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with stylet-driven versus lumenless lead delivery systems for left bundle branch area pacing. Braunstein, ED., Kagan, RD., Olshan, DS., et al.[2023]

Left bundle branch area pacing (LBBAP) is a safe and effective method for patients requiring ventricular pacing, showing no complications during implantation and stable pacing parameters over an average follow-up of 9.2 months.

Patients receiving LBBAP exhibited a right bundle branch block (RBBB) morphology on ECG with significantly shorter QRS duration and stimulus to peak left ventricular activation time compared to those paced at the right ventricular septum, indicating improved electrical activation of the heart.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Implantation of Left Bundle Branch Area Pacing in Patients with and without Bundle Branch Block. Chen, TP., Shi, XJ., Lu, DY., et al.[2021]

A visualization-enhanced technique for left bundle branch pacing (LBBP) implantation significantly reduced procedural time and fluoroscopy duration compared to the standard approach, with times of 66.76 minutes and 7.83 minutes respectively versus 85.46 minutes and 11.11 minutes.

The visualization technique also resulted in fewer lead deployment attempts and a higher success rate in recording left bundle branch potentials (79.3% vs 46.4%), indicating improved efficacy in achieving optimal lead placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-enhanced image-guided lead deployment for left bundle branch pacing. Liu, X., Niu, HX., Gu, M., et al.[2022]

In a study involving 50 bradycardia patients, the Medtronic SelectSecure™ MRI SecureScan™ Model 3830 lead used for left bundle branch area pacing (LBBAP) required an average of 2.1 attempts and 13 rotations for successful placement, indicating that LBBAP implants are more complex than standard pacing procedures.

Bench testing showed that even under extreme simulated conditions, the 3830 lead demonstrated a predicted 10-year conductor fracture rate of only 0.02%, suggesting high reliability and safety for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical use conditions of lead deployment and simulated lead fracture rate in left bundle branch area pacing. Zou, J., Chen, K., Liu, X., et al.[2023]

The Micra leadless pacemaker has evolved to provide atrio-ventricular (AV) synchrony through a unique algorithm that detects mechanical atrial contractions, enhancing its functionality beyond traditional single chamber pacing.

The paper discusses troubleshooting and programming strategies for the Micra AV algorithm, highlighting clinical cases where adjustments were necessary to ensure proper tracking of atrial activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atrio-ventricular synchronous pacing with a single chamber leadless pacemaker: Programming and trouble shooting for common clinical scenarios. El-Chami, MF., Bhatia, NK., Merchant, FM.[2021]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/JAHA.125.042471

Leadless Versus Transvenous Single‐Chamber ... The 3‐year follow‐up report also found lower chronic complications as well as reintervention rates for LPs compared with transvenous pacemakers.

2. member.myhealthtoolkitfl.com member.myhealthtoolkitfl.com/web/public/brands/medicalpolicy/external-policies/leadless-cardiac-pacemakers/

Leadless Cardiac Pacemakers Description Pacemakers are intended to be used as a substitute for the heart's intrinsic pacing system to correct cardiac rhythm disorders.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10518884/

Leadless Pacemakers: State of the Art and Selection ... Leadless pacemakers have been developed to overcome many of the challenges of transvenous pacing while providing safe and effective pacing therapy for an ...

4. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(24)02684-5/fulltext

12-Month results from the Micra AV post-approval registry In this prospective international registry, the Micra AV leadless pacemaker was implanted with a high rate of success with a low rate of major ...

5. academic.oup.com academic.oup.com/eurheartj/article/46/21/1979/8086938

Leadless pacing: a comprehensive review - Oxford Academic An overview of the past, present, and future of leadless pacing: comparison of different leadless pacemakers (LPMs) and their size in millimetre ...

6. academic.oup.com academic.oup.com/eurheartj/article/45/14/1241/7617133

Leadless pacemakers at 5-year follow-up: the Micra ... Long-term outcomes with the Micra leadless pacemaker continue to demonstrate low rates of major complications and system revisions and an ...

7. cardiovascular.abbott cardiovascular.abbott/us/en/hcp/products/cardiac-rhythm-management/pacemakers/aveir-dr-dual-chamber-leadless-pacemaker-system.html

AVEIR Single and Dual Chamber Leadless Pacemaker ... Why AVEIR Leadless Pacemakers? The leadless pacemaker system that offers tailored therapy and adaptability for your patient.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11932076/

The exciting and evolving journey of leadless pacing - PMC The LEADLESS II/Phase 2 study proved the efficacy and safety of the AVEIR-VR and led to the FDA approval in 2022. Hence, increasing the ...

9. medtronic.com medtronic.com/en-us/l/patients/treatments-therapies/pacemakers/our/micra.html

Micra - Pacemakers Micra™ is the world's smallest pacemaker.1 Unlike most pacemakers that are placed in a patient's chest with leads running to the heart, Micra is a leadless ...