Last reviewed · How we verify

NCT05953558: AV-CESAR

French Cohort Evaluating the effectiveneSs of Atrioventricular Synchrony by the micRa AV

Recruiting now Last updated 20 July 2023
What this trial tests

trial testing Patients implanted with Micra AV in Atrioventricular Synchrony by the Micra AV in 1,000 participants. Currently enrolling.

Timeline
1 May 2023
Primary endpoint
1 November 2023
31 December 2027

Quick facts

Lead sponsorParis Sudden Death Expertise Center
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment1,000
Start date1 May 2023
Primary completion1 November 2023
Estimated completion31 December 2027
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Paris Sudden Death Expertise Center

Who can join

Adults 18 to 110, any sex, with Atrioventricular Synchrony by the Micra AV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Transvenous cardiac pacemakers have pitfalls due to lead- and device pocket-related complications. Leadless pacemakers were developed and introduced into clinical practice to overcome the weaknesses of traditional transvenous pacemakers. The absence of atrial pacing has restricted their uses mainly for cases of paroxysmal atrioventricular block (AVB) or AVB with atrial fibrillation. The Micra AV contains an embedded accelerometer that senses the atrial contraction waveform, allowing the ventricle to be paced once the atrial contraction is complete. This atrioventricular synchronization is intended to extend the use of the device to cases of permanent complete AVB with normal sinus function. Two randomized clinicals trials have been proven it's efficacy. However, with AV-CESAR cohort, we aim to evaluate the real word effectiveness of Micra AV, in the first 1000 patients implanted by the device in France.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. One-Year Outcomes of the First 1000 Patients Implanted With the Medtronic Micra AV Leadless Pacing System in France: The AV-CESAR Cohort Study.
    Kerkouri F, Clementy N, Defaye P, Ait Said M, et al · · 2026 · PMID 42159009 · DOI 10.1161/circep.126.014850

Verify or expand the search:

Other Paris Sudden Death Expertise Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05953558.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing