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

Recruiting

• Conditions: Atrioventricular Synchrony by the Micra AV

• Registration Number: NCT05953558
• Lead Sponsor: Paris Sudden Death Expertise Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-06-21
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-17
• Last Update Submitted: 2023-07-17
• Study First Posted: 2023-07-20
• Last Update Posted: 2023-07-20
• Primary Completion: 2023-11-01
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• All patients who underwent Micra AV implantation

Exclusion Criteria

• Refusal of consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Risk factors of a compromised quality of life	Through study completion, an average of 3 years	Identify the risk factors associated with impaired quality of life in patients with Micra AV
Assessment of the quality of life in permanent atrioventricular block and normal sinus function subgroup	Through study completion, an average of 3 years	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.

Trial Locations

Locations (1)

Paris Cardiovascular Research Centre (AV-CESAR Investigators); 🇫🇷 Paris, France