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

Sponsor

Paris Sudden Death Expertise Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05953558

Collaborator

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

1,000

Enrollment

Location

Anticipated Duration (Months)

17.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrioventricular Synchrony by the Micra AV	Device: Patients implanted with Micra AV

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Cohorte Française Des Patients Implantés de Micra AV

Actual Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 31, 2027

Outcome Measures

Primary Outcome Measures

Profile of patients implanted with Micra AV [Through study completion, an average of 3 years]
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)
Follow-up occurrence of upgrading to a dual-chamber pacemaker [Through study completion, an average of 3 years]
Rate of pacemaker syndrome and requirement of dual-chamber pacemaker upgrade
Early and late device-related complications [Through study completion, an average of 3 years]
Rate of inhospital and late complications related to Micra AV

Secondary Outcome Measures

Assessment of the quality of life in permanent atrioventricular block and normal sinus function subgroup [Through study completion, an average of 3 years]
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.
Risk factors of a compromised quality of life [Through study completion, an average of 3 years]
Identify the risk factors associated with impaired quality of life in patients with Micra AV

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 110 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients who underwent Micra AV implantation

Exclusion Criteria:

Refusal of consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Paris Cardiovascular Research Centre (AV-CESAR Investigators)	Paris		France	75015

Investigators

Principal Investigator: Eloi Marijon, MD,PhD, Paris Sudden Death Expertise Center
Principal Investigator: Fawzi Kerkouri, MD, University hospital of Brest

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Paris Sudden Death Expertise Center

ClinicalTrials.gov Identifier:

NCT05953558

Other Study ID Numbers:

2023-A00023-42 Protocole

First Posted:

Jul 20, 2023

Last Update Posted:

Jul 20, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Paris Sudden Death Expertise Center

Pacemaker syndrome

Dual chamber pacemaker upgrade

Study Results

No Results Posted as of Jul 20, 2023