Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05953558

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

Sponsor: Paris Sudden Death Expertise Center

View on ClinicalTrials.gov

Summary

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.

Official title: Cohorte Française Des Patients Implantés de Micra AV

Key Details

Gender

All

Age Range

18 Years - 110 Years

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2023-05-01

Completion Date

2027-12-31

Last Updated

2023-07-20

Healthy Volunteers

No

Interventions

DEVICE

Patients implanted with Micra AV

The first 1000 patients implanted by the device in France

Locations (1)

Paris Cardiovascular Research Centre (AV-CESAR Investigators)

Paris, France