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

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.

Conditions

• Atrioventricular Synchrony by the Micra AV

Interventions

DEVICE

Patients implanted with Micra AV

The first 1000 patients implanted by the device in France

Sponsors & Collaborators

• CHU de Tours

  collaborator UNKNOWN

• European Georges Pompidou Hospital

  collaborator OTHER

• Hôpital privé Clairval - Marseille

  collaborator UNKNOWN

• Clinique Pasteur Toulouse

  collaborator OTHER

• University Hospital, Bordeaux

  collaborator OTHER

• Infirmerie Protestante Lyon

  collaborator AMBIG

• Institut Jacques Cartier - Massy

  collaborator UNKNOWN

• University Hospital, Grenoble

  collaborator OTHER

• Hôpital de la Timone

  collaborator OTHER

• University Hospital, Toulouse

  collaborator OTHER

• Hopital Prive Saint Martin - Bordeaux

  collaborator UNKNOWN

• Hospices Civils de Lyon

  collaborator OTHER

• CHU de Rouen - Accueil

  collaborator OTHER

• University Hospital, Caen

  collaborator OTHER

• Médipôle Lyon-Villeurbanne

  collaborator OTHER

• Hospital Ambroise Paré Paris

  collaborator OTHER

• Clinique Saint Augustin - Bordeaux

  collaborator UNKNOWN

• Rennes University Hospital

  collaborator OTHER

• Clinique de la Sauvegarde - Lyon

  collaborator UNKNOWN

• University Hospital of Saint-Etienne

  collaborator OTHER

• Hôpital Privé de Parly II - Le Chesnay

  collaborator OTHER

• Institut Mutualiste Montsouris

  collaborator OTHER

• Centre Hospitalier Universitaire, Amiens

  collaborator OTHER

• University Hospital, Clermont-Ferrand

  collaborator OTHER

• Centre Hospitalier Régional et Universitaire de Brest

  collaborator OTHER

• Poitiers University Hospital

  collaborator OTHER

• Clinique Saint-Gatien - Tours

  collaborator UNKNOWN

• CHU de Reims

  collaborator OTHER

• Centre Hospitalier Universitaire de Besancon

  collaborator OTHER

• Centre Hospitalier Universitaire Dijon

  collaborator OTHER

• Hôpital Privé de Lille Métropole

  collaborator UNKNOWN

• University Hospital, Montpellier

  collaborator OTHER

• University Hospital, Strasbourg, France

  collaborator OTHER

• Nantes University Hospital

  collaborator OTHER

• Centre Cardio-Thoracique de Monaco

  collaborator UNKNOWN

• Hospital St. Joseph, Marseille, France

  collaborator OTHER

• Centre Hospitalier Régional Metz-Thionville

  collaborator OTHER

• Centre Hospitalier Annecy Genevois

  collaborator OTHER

• Clinique du Millenaire

  collaborator OTHER

• University Hospital, Limoges

  collaborator OTHER

• Clinique Saint Pierre - Perpignan

  collaborator UNKNOWN

• Bichat Hospital

  collaborator OTHER

• Universite de La Reunion

  collaborator OTHER

• CHU de Lille

  collaborator UNKNOWN

• Institute Arnault Tzanck, France

  collaborator OTHER

• Hôpital Privé Les Franciscaines

  collaborator OTHER

• CHU de Fort de France - Martinique

  collaborator UNKNOWN

• Henri Mondor University Hospital

  collaborator OTHER

• University Hospital, Angers

  collaborator OTHER_GOV

• Centre Hospitalier de Lens

  collaborator OTHER

• Central Hospital, Nancy, France

  collaborator OTHER

• Paris Sudden Death Expertise Center

  lead OTHER

Principal Investigators

• Eloi Marijon, MD,PhD · Paris Sudden Death Expertise Center

• Fawzi Kerkouri, MD · University hospital of Brest

Eligibility

Min Age

18 Years

Max Age

110 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-01

Primary Completion

2023-11-01

Completion

2027-12-31

FDA Device

Yes

Countries

• France

Study Locations