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The Leadless AV Versus DDD Pacing Study | Clinical Trials | Clareo Health

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RECRUITINGPhase 4NCT05498376

The Leadless AV Versus DDD Pacing Study

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 ...

Lead sponsor: Insel Gruppe AG, University Hospital Bern•1 locations•View source on ClinicalTrials.gov

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Contacts

Andreas Häberlin, MD

CONTACT

+41 31 664 06 74 [email protected]

Sponsors

Lead Sponsor

Insel Gruppe AG, University Hospital Bern

Collaborators

University of Bern

Age

70 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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

Exclusion Criteria

•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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 18, 2025Terms

Trial snapshot

StatusRECRUITING

PhasePHASE4

Enrollment100

Start dateAug 2022

Last updatedFeb 18, 2025

Condition

Cardiac Pacemaker Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases

Locations shown

Inselspital, Bern University Hospital

Bern

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2025Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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