NCT05498376: LEAVE DDD

The Leadless AV Versus DDD Pacing Study

Recruiting now Phase 4 Last updated 27 March 2026

What this trial tests

Phase 4 trial testing Conventional pacemaker DDD in Cardiac Pacemaker in 100 participants. Currently enrolling.

Timeline

23 August 2022

Primary endpoint
31 December 2026

31 December 2027

Quick facts

Lead sponsor	Insel Gruppe AG, University Hospital Bern
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	23 August 2022
Primary completion	31 December 2026
Estimated completion	31 December 2027
Sites	1 location across Switzerland

Drugs / interventions tested

• Conventional pacemaker DDD
• Leadless pacemaker Micra AV

Conditions studied

• Cardiac Pacemaker — all drugs for Cardiac Pacemaker →
• Arrhythmias, Cardiac — all drugs for Arrhythmias, Cardiac →
• Heart Diseases — all drugs for Heart Diseases →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

Insel Gruppe AG, University Hospital Bern

Who can join

70 and older, any sex, with Cardiac Pacemaker or Arrhythmias, Cardiac. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.