French Cohort Evaluating the effectiveneSs of Atrioventricular Synchrony by the micRa AV (AV-CESAR)

Cohorte Française Des Patients Implantés de Micra AV

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.

Study Overview

• Status: Recruiting
• Conditions: Atrioventricular Synchrony by the Micra AV
• Intervention / Treatment: Device: Patients implanted with Micra AV

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Eloi Marijon, MD,PhD; Phone Number: +33662833848; Email: eloi.marijon@inserm.fr
• Study Contact Backup: Name: Fawzi Kerkouri, MD; Phone Number: +33767149558; Email: eecmcfawzikerkouri@gmail.com

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • Paris Cardiovascular Research Centre (AV-CESAR Investigators)
    • Contact: Eloi Marijon, MD, PHD; Phone Number: +33662833848; Email: eloi.marijon@inserm.fr
    • Contact: Fawzi Kerkouri, MD; Phone Number: +33767149558; Email: eecmcfawzikerkouri@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The first 1000 patients implanted with Micra AV in France since May 29, 2020

Description

Inclusion Criteria:

• All patients who underwent Micra AV implantation

Exclusion Criteria:

• Refusal of consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Through study completion, an average of 3 years
Follow-up occurrence of upgrading to a dual-chamber pacemaker	Rate of pacemaker syndrome and requirement of dual-chamber pacemaker upgrade	Through study completion, an average of 3 years
Early and late device-related complications	Rate of inhospital and late complications related to Micra AV	Through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through study completion, an average of 3 years
Risk factors of a compromised quality of life	Identify the risk factors associated with impaired quality of life in patients with Micra AV	Through study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: Paris Sudden Death Expertise Center
• Collaborators: Hospices Civils de Lyon; University Hospital, Strasbourg, France; University Hospital, Angers; Centre Hospitalier Universitaire Dijon; CHU de Reims; Centre Hospitalier Universitaire, Amiens; University Hospital, Montpellier; Central Hospital, Nancy, France; University Hospital, Bordeaux; Poitiers University Hospital; University Hospital, Clermont-Ferrand; University Hospital, Caen; University Hospital, Limoges; Centre Hospitalier Universitaire de Besancon; University Hospital, Grenoble; Rennes University Hospital; University Hospital, Toulouse; Centre Hospitalier Annecy Genevois; Hospital St. Joseph, Marseille, France; Universite de La Reunion; Henri Mondor University Hospital; European Georges Pompidou Hospital; University Hospital of Saint-Etienne; Bichat Hospital; Centre Hospitalier Régional Metz-Thionville; Hôpital de la Timone; Institut Mutualiste Montsouris; Centre Hospitalier Régional et Universitaire de Brest; Hospital Ambroise Paré Paris; Clinique Pasteur Toulouse; Centre Hospitalier de Lens; Institute Arnault Tzanck, France; CHU de Nantes; CHU de Rouen - Accueil; Infirmerie Protestante Lyon; Clinique du Millenaire; Centre Cardio-Thoracique de Monaco; CHU de Lille; CHU de Tours; Clinique Saint Augustin - Bordeaux; Clinique Saint Pierre - Perpignan; Clinique Saint-Gatien - Tours; Hôpital privé Clairval - Marseille; Hôpital Privé de Parly II - Le Chesnay; Institut Jacques Cartier - Massy; Hôpital Privé Les Franciscaines; Médipôle Lyon-Villeurbanne; Hopital Prive Saint Martin - Bordeaux; Clinique de la Sauvegarde - Lyon; Hôpital Privé de Lille Métropole; CHU de Fort de France - Martinique
• Investigators: Principal Investigator: Eloi Marijon, MD,PhD, Paris Sudden Death Expertise Center; Principal Investigator: Fawzi Kerkouri, MD, University hospital of Brest

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Quality of life; Complications; Effectiveness; SF36 questionnaire; Pacemaker syndrome; Dual chamber pacemaker upgrade
• Other Study ID Numbers: 2023-A00023-42 Protocole

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes