French Cohort Evaluating the effectiveneSs of Atrioventricular Synchrony by the micRa AV

Study Overview
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Brief Summary
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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.

Official Title
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Cohorte Française Des Patients Implantés de Micra AV

Conditions
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Atrioventricular Synchrony by the Micra AV

Intervention / Treatment
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* Device: Patients implanted with Micra AV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who underwent Micra AV implantation Exclusion Criteria: Refusal of consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Patients implanted with Micra AV|The first 1000 patients implanted by the device in France|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pacemaker syndrome, Dual chamber pacemaker upgrade, Quality of life, SF36 questionnaire, Effectiveness, Complications