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

NCT ID: NCT05953558

Last Updated: 2023-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrioventricular Synchrony by the Micra AV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Patients implanted with Micra AV

The first 1000 patients implanted by the device in France

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients who underwent Micra AV implantation

Exclusion Criteria

* Refusal of consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Tours

UNKNOWN

Sponsor Role collaborator

European Georges Pompidou Hospital

OTHER

Sponsor Role collaborator

Hôpital privé Clairval - Marseille

UNKNOWN

Sponsor Role collaborator

Clinique Pasteur Toulouse

OTHER

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role collaborator

Infirmerie Protestante Lyon

AMBIG

Sponsor Role collaborator

Institut Jacques Cartier - Massy

UNKNOWN

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role collaborator

Hôpital de la Timone

OTHER

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role collaborator

Hopital Prive Saint Martin - Bordeaux

UNKNOWN

Sponsor Role collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role collaborator

CHU de Rouen - Accueil

OTHER

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role collaborator

Médipôle Lyon-Villeurbanne

OTHER

Sponsor Role collaborator

Hospital Ambroise Paré Paris

OTHER

Sponsor Role collaborator

Clinique Saint Augustin - Bordeaux

UNKNOWN

Sponsor Role collaborator

Rennes University Hospital

OTHER

Sponsor Role collaborator

Clinique de la Sauvegarde - Lyon

UNKNOWN

Sponsor Role collaborator

University Hospital of Saint-Etienne

OTHER

Sponsor Role collaborator

Hôpital Privé de Parly II - Le Chesnay

OTHER

Sponsor Role collaborator

Institut Mutualiste Montsouris

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role collaborator

Centre Hospitalier Régional et Universitaire de Brest

OTHER

Sponsor Role collaborator

Poitiers University Hospital

OTHER

Sponsor Role collaborator

Clinique Saint-Gatien - Tours

UNKNOWN

Sponsor Role collaborator

CHU de Reims

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role collaborator

Hôpital Privé de Lille Métropole

UNKNOWN

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role collaborator

University Hospital, Strasbourg, France

OTHER

Sponsor Role collaborator

Nantes University Hospital

OTHER

Sponsor Role collaborator

Centre Cardio-Thoracique de Monaco

UNKNOWN

Sponsor Role collaborator

Hospital St. Joseph, Marseille, France

OTHER

Sponsor Role collaborator

Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role collaborator

Centre Hospitalier Annecy Genevois

OTHER

Sponsor Role collaborator

Clinique du Millenaire

OTHER

Sponsor Role collaborator

University Hospital, Limoges

OTHER

Sponsor Role collaborator

Clinique Saint Pierre - Perpignan

UNKNOWN

Sponsor Role collaborator

Bichat Hospital

OTHER

Sponsor Role collaborator

Universite de La Reunion

OTHER

Sponsor Role collaborator

CHU de Lille

UNKNOWN

Sponsor Role collaborator

Institute Arnault Tzanck, France

OTHER

Sponsor Role collaborator

Hôpital Privé Les Franciscaines

OTHER

Sponsor Role collaborator

CHU de Fort de France - Martinique

UNKNOWN

Sponsor Role collaborator

Henri Mondor University Hospital

OTHER

Sponsor Role collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role collaborator

Centre Hospitalier de Lens

OTHER

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role collaborator

Paris Sudden Death Expertise Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eloi Marijon, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Paris Sudden Death Expertise Center

Fawzi Kerkouri, MD

Role: PRINCIPAL_INVESTIGATOR

University hospital of Brest

Locations

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Paris Cardiovascular Research Centre (AV-CESAR Investigators)

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Eloi Marijon, MD,PhD

Role: CONTACT

+33662833848

Fawzi Kerkouri, MD

Role: CONTACT

+33767149558

Facility Contacts

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Eloi Marijon, MD, PHD

Role: primary

+33662833848

Fawzi Kerkouri, MD

Role: backup

+33767149558

Other Identifiers

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2023-A00023-42 Protocole

Identifier Type: -

Identifier Source: org_study_id

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