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

Condition(s) studied

Investigational drug(s) / intervention(s)

Patients implanted with Micra AV: The first 1000 patients implanted by the device in France

Study 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. 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.

Eligibility

Primary outcome measure(s)

• Profile of patients implanted with Micra AV — 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 — 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 — Through study completion, an average of 3 years
  Rate of inhospital and late complications related to Micra AV

Trial sites (1)

More Paris Sudden Death Expertise Center trials in France