Evaluating the effectiveness of the Micra AV pacemaker
Cohorte Française Des Patients Implantés de Micra AV
Paris Sudden Death Expertise Center · NCT05953558
This study is testing how well the Micra AV leadless pacemaker works for people with atrioventricular block to see if it improves their quality of life and heart function.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | Paris Sudden Death Expertise Center (other) |
| Locations | 1 site (Paris) |
| Trial ID | NCT05953558 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the real-world effectiveness of the Micra AV leadless pacemaker in patients with atrioventricular block. The Micra AV utilizes an embedded accelerometer to synchronize ventricular pacing with atrial contractions, potentially expanding its use beyond traditional indications. The study will involve the first 1000 patients implanted with the device in France, collecting data on outcomes such as quality of life and effectiveness. The findings will help determine the practical benefits of this innovative pacing technology in everyday clinical settings.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have undergone Micra AV implantation.
Not a fit: Patients who refuse consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality of life for patients with atrioventricular block by providing a safer and more effective pacing option.
How similar studies have performed: Previous randomized clinical trials have demonstrated the efficacy of the Micra AV, indicating a promising outlook for this observational study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients who underwent Micra AV implantation Exclusion Criteria: * Refusal of consent
Where this trial is running
Paris
- Paris Cardiovascular Research Centre (AV-CESAR Investigators) — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Eloi Marijon, MD,PhD — Paris Sudden Death Expertise Center
- Study coordinator: Eloi Marijon, MD,PhD
- Email: eloi.marijon@inserm.fr
- Phone: +33662833848
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrioventricular Synchrony by the Micra AV, Pacemaker syndrome, Dual chamber pacemaker upgrade, Quality of life, SF36 questionnaire, Effectiveness, Complications