Clinical trial NCT05953558: French Cohort Evaluating the effectiveneSs of Atrioventricular Synchrony by the micRa AV
Official title: Cohorte Française Des Patients Implantés de Micra AV
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrioventricular Synchrony by the Micra AV
Keywords: Pacemaker syndrome
Dual chamber pacemaker upgrade
Quality of life
SF36 questionnaire
Effectiveness
Complications
Lead sponsor: Paris Sudden Death Expertise Center
Sponsor class: OTHER
Collaborators: name: CHU de Tours
name: European Georges Pompidou Hospital
name: Hôpital privé Clairval - Marseille
name: Clinique Pasteur Toulouse
name: University Hospital, Bordeaux
name: Infirmerie Protestante Lyon
name: Institut Jacques Cartier - Massy
name: University Hospital, Grenoble
name: Hôpital de la Timone
name: University Hospital, Toulouse
name: Hopital Prive Saint Martin - Bordeaux
name: Hospices Civils de Lyon
name: CHU de Rouen - Accueil
name: University Hospital, Caen
name: Médipôle Lyon-Villeurbanne
name: Hospital Ambroise Paré Paris
name: Clinique Saint Augustin - Bordeaux
name: Rennes University Hospital
name: Clinique de la Sauvegarde - Lyon
name: University Hospital of Saint-Etienne
name: Hôpital Privé de Parly II - Le Chesnay
name: Institut Mutualiste Montsouris
name: Centre Hospitalier Universitaire, Amiens
name: University Hospital, Clermont-Ferrand
name: Centre Hospitalier Régional et Universitaire de Brest
name: Poitiers University Hospital
name: Clinique Saint-Gatien - Tours
name: CHU de Reims
name: Centre Hospitalier Universitaire de Besancon
name: Centre Hospitalier Universitaire Dijon
name: Hôpital Privé de Lille Métropole
name: University Hospital, Montpellier
name: University Hospital, Strasbourg, France
name: Nantes University Hospital
name: Centre Cardio-Thoracique de Monaco
name: Hospital St. Joseph, Marseille, France
name: Centre Hospitalier Régional Metz-Thionville
name: Centre Hospitalier Annecy Genevois
name: Clinique du Millenaire
name: University Hospital, Limoges
name: Clinique Saint Pierre - Perpignan
name: Bichat Hospital
name: Universite de La Reunion
name: CHU de Lille
name: Institute Arnault Tzanck, France
name: Hôpital Privé Les Franciscaines
name: CHU de Fort de France - Martinique
name: Henri Mondor University Hospital
name: University Hospital, Angers
name: Centre Hospitalier de Lens
name: Central Hospital, Nancy, France
First posted: 2023-07-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The first 1000 patients implanted with Micra AV in France since May 29, 2020

Brief 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.


Eligibility criteria: Inclusion Criteria:

* All patients who underwent Micra AV implantation

Exclusion Criteria:

* Refusal of consent

Primary outcomes:
measure: Profile of patients implanted with Micra AV
timeFrame: Through study completion, an average of 3 years
measure: Follow-up occurrence of upgrading to a dual-chamber pacemaker
timeFrame: Through study completion, an average of 3 years
measure: Early and late device-related complications
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
measure: Assessment of the quality of life in permanent atrioventricular block and normal sinus function subgroup
timeFrame: Through study completion, an average of 3 years
measure: Risk factors of a compromised quality of life
timeFrame: Through study completion, an average of 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Paris Cardiovascular Research Centre (AV-CESAR Investigators)
Study officials:
affiliation: Paris Sudden Death Expertise Center
name: Eloi Marijon, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University hospital of Brest
name: Fawzi Kerkouri, MD
role: PRINCIPAL_INVESTIGATOR
References: