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 Type
OBSERVATIONAL
Enrollment
1,000
The first 1000 patients implanted by the device in France
Paris Cardiovascular Research Centre (AV-CESAR Investigators)
Paris, France
RECRUITINGProfile 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)
Time frame: 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
Time frame: Through study completion, an average of 3 years
Early and late device-related complications
Rate of inhospital and late complications related to Micra AV
Time frame: Through study completion, an average of 3 years
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.
Time frame: 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
Time frame: Through study completion, an average of 3 years
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