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Cardiac PacemakerPhase 4LEAVE DDDNCT05498376

The Leadless AV Versus DDD Pacing Study

A Phase 4 study testing Conventional pacemaker DDD and Leadless pacemaker Micra AV in people with Cardiac Pacemaker and Arrhythmias, Cardiac, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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"). Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
Conventional pacemaker DDD and Leadless pacemaker Micra AV
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSwitzerland
Study dates
23 Aug 2022to 31 Dec 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Inselspital, Bern University Hospital

    Bern, 3010

Other trials in Switzerland

About this study

Official title: The Leadless AV Versus DDD Pacing Study: A Randomized Controlled Single-center Trial on Leadless Versus Conventional Cardiac Dual-chamber Pacing

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.

Being tested
Conventional pacemaker DDD, Leadless pacemaker Micra AV
Keywords
Leadless pacemaker, Atrioventricular conduction block, Bradyarrhythmias, Micra
Medical subject headings
Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Atrioventricular Block, Bradycardia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional pacemaker DDDDevice

    Implantation of a conventional cardiac pacemaker

  • Leadless pacemaker Micra AVDevice

    Implantation of a leadless cardiac pacemaker

Study groups in NCT05498376
Study groupRoleWhat they receive
Conventional pacemaker DDDActive comparatorImplantation of a conventional dual-chamber PM
Receives: Device: Conventional pacemaker DDD
Leadless pacemaker Micra AVActive comparatorImplantation of a leadless pacemaker system (Micra AV™)
Receives: Device: Leadless pacemaker Micra AV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Exercise capacity

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

    Measured: Month 3 post implantation

Secondary outcomes (18)

  1. Total implantation time

    Total implantation time

    Measured: During implantation on day 0

  2. Total fluoroscopy time

    Total fluoroscopy time during implantation

    Measured: During implantation on day 0

  3. Total fluoroscopy dosage

    Total fluoroscopy dosage during implantation

    Measured: During implantation on day 0

  4. Pacing thresholds

    Pacing thresholds of the implanted pacemaker

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

  5. Sensing values

    Sensing values of the implanted pacemaker

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

  6. Impedance values

    Impedance values of the implanted pacemaker

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

  7. Duration of exercise

    Duration of exercise until exhaustion assessed by spiroergometry

    Measured: Month 3 post implantation

  8. VO2max

    VO2max assessed by spiroergometry

    Measured: Month 3 post implantation

  9. VE/VCO2

    VE/VCO2 assessed by spiroergometry

    Measured: Month 3 post implantation

  10. VE/VO2

    VE/VO2 assessed by spiroergometry

    Measured: Month 3 post implantation

  11. Maximum atrial heart rate

    Maximum atrial heart rate as assessed by spiroergometry

    Measured: Month 3 post implantation

  12. Left ventricular ejection fraction (LVEF)

    LVEF as assessed by echocardiography

    Measured: Day 0 and months 3, 12 and 24 post implantation

  13. Degree of tricuspid valve regurgitation

    Degree of tricuspid valve regurgitation assessed by trans-thoracic echocardiogram. The degree of tricuspid valve regurgitation will be classified as "none", "mild", "moderate" or "severe"

    Measured: Day 0 and months 3, 12 and 24 post implantation

  14. Degree of mitral valve regurgitation

    Degree of mitral valve regurgitation assessed by trans-thoracic echocardiogram. The degree of mitral valve regurgitation will be classified as "none", "mild", "moderate" or "severe"

    Measured: Day 0 and months 3, 12 and 24 post implantation

  15. Quality of Life scores measured with the EQ-5D-5L Questionnaire

    Quality of Life scores measured with the EQ-5D-5L Questionnaire Scores: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each with a 5-scale response option; current health state assessed with a number between 0 and 100

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

  16. AV synchrony

    Measured: Day 1 and months 1,3,12 and 24 post implantation

  17. Laboratory

    NT-proBNP

    Measured: Day 0 and month 3 post implantation

  18. Safety outcomes

    Major adverse events (death, cardiac tamponade, any surgical reintervention, pocket/groin problems, lead/device dislocations; electrode noise, pacing impedance out of range (<200 or >2000Ω), failure to capture at maximum output, infections and thrombosis/embolism); rate of pacemaker syndrome developed by patients; rate of device upgrades/revisions required

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2022
  2. Study start23 Aug 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05498376
Sponsor's protocol ID
2021-D0050
Acronym
LEAVE DDD
Status last verified
Apr 2026
First submitted
3 Aug 2022
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 23801822

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Conventional pacemaker DDD and Leadless pacemaker Micra AV in people with Cardiac Pacemaker and Arrhythmias, Cardiac, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exercise capacity (time frame: Month 3 post implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05498376, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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