The Leadless AV Versus DDD Pacing Study

NCT05498376 | Recruiting Phase 4 DMC

• 1 other identifier: 2021-D0050
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac pacemaker (PM) implantation is the established treatment for relevant bradyarrhythmias. Conventional PMs require 1-3 pacing leads to register the heart's intrinsic activity ("sensing") and to deliver the electrical stimuli to the heart ("pacing"). These leads are responsible for the vast majority of morbidity after implantation and PM failures. Therefore, a leadless PM system (Micra TPS™, Medtronic, United States) has been introduced a few years ago. This system overcomes the limitations of leads, however, the first generation of the Micra TPS™ only allowed sensing and pacing in the right ventricle. More recently, an upgraded version has been introduced and gained market approval (Micra AV, Medtronic, United States). According to published results from several clinical trials, this device allows sensing the atrial activity and, thus, timing the delivery of the ventricular pacing impulse in a physiological manner similar to a conventional dual-chamber PM with two leads. Clinical feasibility and safety for this concept have been established already. However, it is unclear if this translates into a direct clinical benefit for patients in comparison to conventional PM systems. The aim of this trial is to compare the therapeutic efficacy of the Micra AV™ PM and conventional dual-chamber PM systems in patients with intermittent or permanent atrioventricular conduction block and a PM indication according to the latest European guidelines. Thus, patients will be randomized to either a conventional dual-chamber PM implantation or the implantation of a leadless Micra AV™ system. Patients will be stratified for gender (female/male) and a priori estimated physical exercise capacity ("fit"/"unfit"). The primary outcome will be the physical exercise capacity of the patients. The null hypothesis with regards to the primary endpoint is that the leadless pacemaker arm shows an inferior VO2 anaerobic threshold than the conventional pacemaker arm. Hence the alternative hypothesis postulates that the leadless pacemaker arm shows a non-inferior VO2 anaerobic threshold compared to the conventional pacemaker arm. Rejection of the null hypothesis is needed to conclude non-inferiority.

Conditions

Cardiac Pacemaker; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases

Keywords

Leadless pacemaker; Atrioventricular conduction block; Bradyarrhythmias; Micra

Outcome Measures

Primary Outcomes (1)

• Exercise capacity

  Exercise capacity (VO2 at anaerobic threshold) as assessed by spiroergometry

  Month 3 post implantation

Secondary Outcomes (18)

• Total implantation time

  During implantation on day 0

• Total fluoroscopy time

  During implantation on day 0

• Total fluoroscopy dosage

  During implantation on day 0

• Pacing thresholds

  Days 0,1 and months 1,3,12 and 24 post implantation

• Sensing values

  Days 0,1 and months 1,3,12 and 24 post implantation

Study Arms (2)

Conventional pacemaker DDD

ACTIVE COMPARATOR

Implantation of a conventional dual-chamber PM

Device: Conventional pacemaker DDD

Leadless pacemaker Micra AV

ACTIVE COMPARATOR

Implantation of a leadless pacemaker system (Micra AV™)

Device: Leadless pacemaker Micra AV

Interventions

Leadless pacemaker Micra AV DEVICE

Implantation of a leadless cardiac pacemaker

Leadless pacemaker Micra AV

Conventional pacemaker DDD DEVICE

Implantation of a conventional cardiac pacemaker

Conventional pacemaker DDD

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients (≥70y) undergoing a de-novo pacemaker implantation due to intermittent or permanent AV block, qualifying for a conventional or leadless pacemaker
• Written informed consent

You may not qualify if:

• Permanent atrial fibrillation or atrial standstill
• Evidence of sinus node disease and need for right atrial pacing (not possible with Micra AV)
• LVEF \<50% and permanent high-degree or total AVB (requiring CRT/His-Bundle/CSP pacing)
• Preoperative E/A ratio \>1.5 in the echocardiography
• Any co-existing ICD indications (no leadless ICD systems available)
• Hemodialysis
• Presence of a mechanical tricuspid valve prosthesis
• Unwilling or unable to comply fully with study procedures and follow-up

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (1)

Inselspital, Bern University Hospital

Bern, 3010, Switzerland

RECRUITING

Related Publications (1)

• Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt OA, Cleland J, Deharo JC, Delgado V, Elliott PM, Gorenek B, Israel CW, Leclercq C, Linde C, Mont L, Padeletti L, Sutton R, Vardas PE; ESC Committee for Practice Guidelines (CPG); Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Kirchhof P, Blomstrom-Lundqvist C, Badano LP, Aliyev F, Bansch D, Baumgartner H, Bsata W, Buser P, Charron P, Daubert JC, Dobreanu D, Faerestrand S, Hasdai D, Hoes AW, Le Heuzey JY, Mavrakis H, McDonagh T, Merino JL, Nawar MM, Nielsen JC, Pieske B, Poposka L, Ruschitzka F, Tendera M, Van Gelder IC, Wilson CM. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J. 2013 Aug;34(29):2281-329. doi: 10.1093/eurheartj/eht150. Epub 2013 Jun 24. No abstract available.

  PMID: 23801822 BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Atrioventricular Block; Bradycardia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Block; Cardiac Conduction System Disease

Study Officials

• Andreas Häberlin, MD

  Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Häberlin, MD

CONTACT

+41 31 664 06 74; Andreas.Haeberlin@insel.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 12, 2022
• Study Start: August 23, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)