Atrioventricular Synchrony by the Micra AVAV-CESARNCT05953558
French Cohort Evaluating the effectiveneSs of Atrioventricular Synchrony by the micRa AV
An observational study of Atrioventricular Synchrony by the Micra AV, run by Paris Sudden Death Expertise Center at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Atrioventricular Synchrony by the Micra AV
- What is being tested?
- Patients implanted with Micra AV
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2023to 31 Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The first 1000 patients implanted with Micra AV in France since May 29, 2020
Who may be able to join
- All patients who underwent Micra AV implantation
Who cannot join
- Refusal of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Paris Cardiovascular Research Centre (AV-CESAR Investigators)
Paris, 75015
Eloi Marijon, MD, PHD, +33662833848, eloi.marijon@inserm.fr
Fawzi Kerkouri, MD, +33767149558, eecmcfawzikerkouri@gmail.com
About this study
Official title: 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.
- Being tested
- Patients implanted with Micra AV
- Keywords
- Pacemaker syndrome, Dual chamber pacemaker upgrade, Quality of life, SF36 questionnaire, Effectiveness, Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients implanted with Micra AVDevice
The first 1000 patients implanted by the device in France
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Through study completion, an average of 3 years
Early and late device-related complications
Rate of inhospital and late complications related to Micra AV
Measured: Through study completion, an average of 3 years
Secondary outcomes (2)
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.
Measured: 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
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 May 2023
- Primary completion1 Nov 2023 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrioventricular Synchrony by the Micra AVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Paris Sudden Death Expertise Center
- Sponsor type
- University, hospital or other
- Collaborators
- CHU de Tours, European Georges Pompidou Hospital, Hôpital privé Clairval - Marseille, Clinique Pasteur Toulouse, University Hospital, Bordeaux, Infirmerie Protestante Lyon, Institut Jacques Cartier - Massy, University Hospital, Grenoble, Hôpital de la Timone, University Hospital, Toulouse, Hopital Prive Saint Martin - Bordeaux, Hospices Civils de Lyon, CHU de Rouen - Accueil, University Hospital, Caen, Médipôle Lyon-Villeurbanne, Hospital Ambroise Paré Paris, Clinique Saint Augustin - Bordeaux, Rennes University Hospital, Clinique de la Sauvegarde, University Hospital of Saint-Etienne, Hôpital Privé de Parly II - Le Chesnay, Institut Mutualiste Montsouris, Centre Hospitalier Universitaire, Amiens, University Hospital, Clermont-Ferrand, Centre Hospitalier Régional et Universitaire de Brest, Poitiers University Hospital, Clinique Saint-Gatien - Tours, CHU de Reims, Centre Hospitalier Universitaire de Besancon, Centre Hospitalier Universitaire Dijon, Hôpital Privé de Lille Métropole, University Hospital, Montpellier, University Hospital, Strasbourg, France, Nantes University Hospital, Centre Cardio-Thoracique de Monaco, Hospital St. Joseph, Marseille, France, Centre Hospitalier Régional Metz-Thionville, Centre Hospitalier Annecy Genevois, Clinique du Millenaire, University Hospital, Limoges, Clinique Saint Pierre - Perpignan, Bichat Hospital, Universite de La Reunion, CHU de Lille, Institute Arnault Tzanck, France, Hôpital Privé Les Franciscaines, CHU de Fort de France - Martinique, Henri Mondor University Hospital, University Hospital, Angers, Centre Hospitalier de Lens, Central Hospital, Nancy, France
- Responsible party
- Sponsor
- Investigators
- Eloi Marijon, MD,PhD, Principal investigator, Paris Sudden Death Expertise CenterFawzi Kerkouri, MD, Principal investigator, University hospital of Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953558
- Sponsor's protocol ID
- 2023-A00023-42 Protocole
- Acronym
- AV-CESAR
- Status last verified
- Jul 2023
- First submitted
- 21 Jun 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Kerkouri F, Clementy N, Defaye P, Ait Said M, Andorin A, Anselme F, Aoudjeghout W, Badoz M, Behar N, Benhenda N, Ben Kilani M, Bodin A, Bordachar P, Bouzeman A, Citerne O, Deharo JC, Dommerc C, Echivard M, Extramiana F, Fauchier L, Garcia R, Gitenay E, Guenancia C, Guy-Moyat B, Jacon P, Jesel L, Juin C, Khoueiry Z, Kubala M, Leclercq C, Mansourati V, Marquie C, Mechulan A, Mondoly P, Narayanan K, Ollitrault P, Pasquie JL, Peret A, Poty H, Sebag F, Villejoubert O, Waintraub X, Waldmann V, Boveda S, Mansourati J, Marijon E; AV-CESAR Investigators. One-Year Outcomes of the First 1000 Patients Implanted With the Medtronic Micra AV Leadless Pacing System in France: The AV-CESAR Cohort Study. Circ Arrhythm Electrophysiol. 2026 Jun;19(6):e014850. doi: 10.1161/CIRCEP.126.014850. Epub 2026 May 20.
PubMed 42159009
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohorte Française Des Patients Implantés de Micra AV
- ClinicalTrials.gov ID
- NCT05953558
- Acronym / sponsor ID
- AV-CESAR / 2023-A00023-42 Protocole
- Keywords
- Pacemaker syndrome, Dual chamber pacemaker upgrade, Quality of life, SF36 questionnaire, Effectiveness, Complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Paris Sudden Death Expertise CenterUniversity, hospital or other
- Collaborators
- CHU de Tours, European Georges Pompidou Hospital, Hôpital privé Clairval - Marseille, Clinique Pasteur Toulouse, University Hospital, Bordeaux, Infirmerie Protestante Lyon, Institut Jacques Cartier - Massy, University Hospital, Grenoble, Hôpital de la Timone, University Hospital, Toulouse, Hopital Prive Saint Martin - Bordeaux, Hospices Civils de Lyon, CHU de Rouen - Accueil, University Hospital, Caen, Médipôle Lyon-Villeurbanne, Hospital Ambroise Paré Paris, Clinique Saint Augustin - Bordeaux, Rennes University Hospital, Clinique de la Sauvegarde, University Hospital of Saint-Etienne, Hôpital Privé de Parly II - Le Chesnay, Institut Mutualiste Montsouris, Centre Hospitalier Universitaire, Amiens, University Hospital, Clermont-Ferrand, Centre Hospitalier Régional et Universitaire de Brest, Poitiers University Hospital, Clinique Saint-Gatien - Tours, CHU de Reims, Centre Hospitalier Universitaire de Besancon, Centre Hospitalier Universitaire Dijon, Hôpital Privé de Lille Métropole, University Hospital, Montpellier, University Hospital, Strasbourg, France, Nantes University Hospital, Centre Cardio-Thoracique de Monaco, Hospital St. Joseph, Marseille, France, Centre Hospitalier Régional Metz-Thionville, Centre Hospitalier Annecy Genevois, Clinique du Millenaire, University Hospital, Limoges, Clinique Saint Pierre - Perpignan, Bichat Hospital, Universite de La Reunion, CHU de Lille, Institute Arnault Tzanck, France, Hôpital Privé Les Franciscaines, CHU de Fort de France - Martinique, Henri Mondor University Hospital, University Hospital, Angers, Centre Hospitalier de Lens, Central Hospital, Nancy, France
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The first 1000 patients implanted with Micra AV in France since May 29, 2020
Key inclusion criteria (1 listed)
- All patients who underwent Micra AV implantation
Key exclusion criteria (1 listed)
- Refusal of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients implanted with Micra AVThe first 1000 patients implanted by the device in France | Device | – |
Primary outcome
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)
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
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
2 secondary outcomes
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
Risk factors of a compromised quality of life
Time frame: Through study completion, an average of 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Derived from this study: PubMed 42159009Kerkouri F, Clementy N, Defaye P, Ait Said M, Andorin A, Anselme F, Aoudjeghout W, Badoz M, Behar N, Benhenda N, Ben Kilani M, Bodin A, Bordachar P, Bouzeman A, Citerne O, Deharo JC, Dommerc C, Echivard M, Extramiana F, Fauchier L, Garcia R, Gitenay E, Guenancia C, Guy-Moyat B, Jacon P, Jesel L, Juin C, Khoueiry Z, Kubala M, Leclercq C, Mansourati V, Marquie C, Mechulan A, Mondoly P, Narayanan K, Ollitrault P, Pasquie JL, Peret A, Poty H, Sebag F, Villejoubert O, Waintraub X, Waldmann V, Boveda S, Mansourati J, Marijon E; AV-CESAR Investigators. One-Year Outcomes of the First 1000 Patients Implanted With the Medtronic Micra AV Leadless Pacing System in France: The AV-CESAR Cohort Study. Circ Arrhythm Electrophysiol. 2026 Jun;19(6):e014850. doi: 10.1161/CIRCEP.126.014850. Epub 2026 May 20.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eloi Marijon, MD,PhD principal investigator
Paris Sudden Death Expertise Center
Fawzi Kerkouri, MD principal investigator
University hospital of Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrioventricular Synchrony by the Micra AV, run by Paris Sudden Death Expertise Center at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eloi Marijon, MD,PhD (+33662833848, eloi.marijon@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profile of patients implanted with Micra AV (time frame: Through study completion, an average of 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05953558, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.