French Cohort Evaluating the effectiveneSs of Atrioventricular Synchrony by the micRa AV
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patients implanted with Micra AV.
- Who it may be relevant to
- Registry conditions: Atrioventricular Synchrony by the Micra AV. Basic parameters: 18 years — 110 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cohorte Française Des Patients Implantés de Micra AV
Overview
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.
Interventions
- Device Patients implanted with Micra AV
The first 1000 patients implanted by the device in France
Primary outcome measures
- Profile of patients implanted with Micra AV [Time frame: Through study completion, an average of 3 years]
- Follow-up occurrence of upgrading to a dual-chamber pacemaker [Time frame: Through study completion, an average of 3 years]
- Early and late device-related complications [Time frame: Through study completion, an average of 3 years]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- All patients who underwent Micra AV implantation
Exclusion criteria
- Refusal of consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Paris Cardiovascular Research Centre (AV-CESAR Investigators) — Paris
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, PMID 42159009
Identifiers
NCT: NCT05953558 · 2023-A00023-42 Protocole