Paris Cardiovascular Research Centre (AV-CESAR Investigators)
Paris, 75015, France
Location status: Recruiting
Location contact
Eloi Marijon, MD, PHD
CONTACT
Fawzi Kerkouri, MD
CONTACT
Recruiting
NCT Number: NCT05953558
French Cohort Evaluating the effectiveneSs of Atrioventricular Synchrony by the 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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–110 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- All patients who underwent Micra AV implantation
Exclusion criteria
- Refusal of consent
Treatment and study plan
Patients implanted with Micra AV
DeviceThe first 1000 patients implanted by the device in France
Primary outcomes
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Profile of patients implanted with Micra AV
Time frame: 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)
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Follow-up occurrence of upgrading to a dual-chamber pacemaker
Time frame: Through study completion, an average of 3 years
Rate of pacemaker syndrome and requirement of dual-chamber pacemaker upgrade
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Early and late device-related complications
Time frame: Through study completion, an average of 3 years
Rate of inhospital and late complications related to Micra AV
Secondary outcomes
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Assessment of the quality of life in permanent atrioventricular block and normal sinus function subgroup
Time frame: 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.
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Risk factors of a compromised quality of life
Time frame: Through study completion, an average of 3 years
Identify the risk factors associated with impaired quality of life in patients with Micra AV
Study contacts
Contact information is provided by the study sponsor or research team.
Eloi Marijon, MD,PhD
CONTACT
Fawzi Kerkouri, MD
CONTACT
Sponsors and collaborators
Lead sponsor
Paris Sudden Death Expertise Center
Other
Collaborators
- Bichat Hospital
- CHU de Fort de France - Martinique
- CHU de Lille
- CHU de Reims
- CHU de Rouen - Accueil
- CHU de Tours
- Central Hospital, Nancy, France
- Centre Cardio-Thoracique de Monaco
- Centre Hospitalier Annecy Genevois
- Centre Hospitalier Régional Metz-Thionville
- Centre Hospitalier Régional et Universitaire de Brest
- Centre Hospitalier Universitaire Dijon
- Centre Hospitalier Universitaire de Besancon
- Centre Hospitalier Universitaire, Amiens
- Centre Hospitalier de Lens
- Clinique Pasteur Toulouse
- Clinique Saint Augustin - Bordeaux
- Clinique Saint Pierre - Perpignan
- Clinique Saint-Gatien - Tours
- Clinique de la Sauvegarde
- Clinique du Millenaire
- European Georges Pompidou Hospital
- Henri Mondor University Hospital
- Hopital Prive Saint Martin - Bordeaux
- Hospices Civils de Lyon
- Hospital Ambroise Paré Paris
- Hospital St. Joseph, Marseille, France
- Hôpital Privé Les Franciscaines
- Hôpital Privé de Lille Métropole
- Hôpital Privé de Parly II - Le Chesnay
- Hôpital de la Timone
- Hôpital privé Clairval - Marseille
- Infirmerie Protestante Lyon
- Institut Jacques Cartier - Massy
- Institut Mutualiste Montsouris
- Institute Arnault Tzanck, France
- Médipôle Lyon-Villeurbanne
- Nantes University Hospital
- Poitiers University Hospital
- Rennes University Hospital
- Universite de La Reunion
- University Hospital of Saint-Etienne
- University Hospital, Angers
- University Hospital, Bordeaux
- University Hospital, Caen
- University Hospital, Clermont-Ferrand
- University Hospital, Grenoble
- University Hospital, Limoges
- University Hospital, Montpellier
- University Hospital, Strasbourg, France
- University Hospital, Toulouse
Registry information
Official study title
Cohorte Française Des Patients Implantés de Micra AV
Acronym: AV-CESAR
Important dates
- Study start
- 2023
- Primary completion
- 2023
- Study completion
- 2027
- First posted
- Jul 20, 2023
- Registry last updated
- Jul 20, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.