French Cohort Evaluating the effectiveneSs of Atrioventricular Synchrony by the micRa AV
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-110
SponsorParis Sudden Death Expertise Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
All patients who underwent Micra AV implantation
Disqualifiers
Refusal of consent
Trial population
The first 1000 patients implanted with Micra AV in France since May 29, 2020
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Patients implanted with Micra AV
DeviceThe first 1000 patients implanted by the device in France
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Profile of patients implanted with Micra AV
Description of the population of patients implanted by the device : age, sex, comorbidities (rate of hypertension, diabetes, ischemic heart disease, heart failure, severe pulmonary disease, severe chronic renal failure, cirrhosis, severe impairement of mobility, severe psychiatric disease or demencia and TAVR)
Time frame
Through study completion, an average of 3 years2
Follow-up occurrence of upgrading to a dual-chamber pacemaker
Rate of pacemaker syndrome and requirement of dual-chamber pacemaker upgrade
Time frame
Through study completion, an average of 3 years3
Early and late device-related complications
Rate of inhospital and late complications related to Micra AV
Time frame
Through study completion, an average of 3 yearsSecondary outcomes
1
Assessment of the quality of life in permanent atrioventricular block and normal sinus function subgroup
Evaluation of the quality of life using the 36-item Short Form (SF-36) questionnaire in the subgroup of 150 patients implanted for permanent atrioventricular block and normal sinus function. SF-36 is a self-report questionnaire and composed of eight multi-item scales (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health), with scores for each of these scales ranging from 0 to 100. Higher scores indicate better health status. A mean score of 50 has been articulated as a normative value for all scales. The SF-36 has been translated and validated in French language.
Time frame
Through study completion, an average of 3 years2
Risk factors of a compromised quality of life
Identify the risk factors associated with impaired quality of life in patients with Micra AV
Time frame
Through study completion, an average of 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Paris Sudden Death Expertise Center
Lead sponsor
CHU de Tours
Collaborator
European Georges Pompidou Hospital
Collaborator
Hôpital privé Clairval - Marseille
Collaborator
Clinique Pasteur Toulouse
Collaborator
University Hospital, Bordeaux
Collaborator
Infirmerie Protestante Lyon
Collaborator
Institut Jacques Cartier - Massy
Collaborator
University Hospital, Grenoble
Collaborator
Hôpital de la Timone
Collaborator
University Hospital, Toulouse
Collaborator
Hopital Prive Saint Martin - Bordeaux
Collaborator
Hospices Civils de Lyon
Collaborator
CHU de Rouen - Accueil
Collaborator
University Hospital, Caen
Collaborator
Médipôle Lyon-Villeurbanne
Collaborator
Hospital Ambroise Paré Paris
Collaborator
Clinique Saint Augustin - Bordeaux
Collaborator
Rennes University Hospital
Collaborator
Clinique de la Sauvegarde - Lyon
Collaborator
University Hospital of Saint-Etienne
Collaborator
Hôpital Privé de Parly II - Le Chesnay
Collaborator
Institut Mutualiste Montsouris
Collaborator
Centre Hospitalier Universitaire, Amiens
Collaborator
University Hospital, Clermont-Ferrand
Collaborator
Centre Hospitalier Régional et Universitaire de Brest
Collaborator
Poitiers University Hospital
Collaborator
Clinique Saint-Gatien - Tours
Collaborator
CHU de Reims
Collaborator
Centre Hospitalier Universitaire de Besancon
Collaborator
Centre Hospitalier Universitaire Dijon
Collaborator
Hôpital Privé de Lille Métropole
Collaborator
University Hospital, Montpellier
Collaborator
University Hospital, Strasbourg, France
Collaborator
Nantes University Hospital
Collaborator
Centre Cardio-Thoracique de Monaco
Collaborator
Hospital St. Joseph, Marseille, France
Collaborator
Centre Hospitalier Régional Metz-Thionville
Collaborator
Centre Hospitalier Annecy Genevois
Collaborator
Clinique du Millenaire
Collaborator
University Hospital, Limoges
Collaborator
Clinique Saint Pierre - Perpignan
Collaborator
Bichat Hospital
Collaborator
Universite de La Reunion
Collaborator
CHU de Lille
Collaborator
Institute Arnault Tzanck, France
Collaborator
Hôpital Privé Les Franciscaines
Collaborator
CHU de Fort de France - Martinique
Collaborator
Henri Mondor University Hospital
Collaborator
University Hospital, Angers
Collaborator
Centre Hospitalier de Lens
Collaborator
Central Hospital, Nancy, France
Collaborator
Source ClinicalTrials.gov