Monitoring the safety and effectiveness of leadless pacemakers in France
France LEADLESS, A Safety and Effectiveness Monitoring in France for AVEIR VR LP and AVEIR AR LP
This study is testing if new leadless pacemakers are safe and effective for patients who need heart rhythm support, making the process easier and more comfortable for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | French Cardiology Society Academic / other |
| Locations | 1 site (La Tronche) |
| Trial ID | NCT06262295 on ClinicalTrials.gov |
What this trial studies
This observational national registry, known as France LEADLESS, aims to confirm the safety and efficacy of the AVEIR VR LP and AVEIR AR LP leadless pacemaker systems in patients requiring VVI(R) or AAI(R) pacemakers. The study involves both retrospective and prospective data collection from multiple centers across France, allowing for comprehensive follow-up of all patients implanted with these devices. By eliminating the need for traditional surgical procedures, this approach seeks to enhance patient comfort and reduce complications associated with conventional pacemakers.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who have been implanted with an AVEIR VR LP or AR LP device.
Not a fit: Patients under 18 years of age or those who refuse to participate in the study will not benefit.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and comfort for patients receiving leadless pacemakers.
How similar studies have performed: Previous studies on leadless pacemakers have shown promising results, indicating a potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patient has been or will be implanted with device AVEIR VR LP and/or device AVEIR AR LP * Patient over 18 years old * Patient informed of the nature of the study, agrees to participate in the study Exclusion Criteria: * Patient under 18 years of age * Patient refusing to participate in the study
Where this trial is running
La Tronche
- Chu de Grenoble - Hopital Michallon — La Tronche, France (Recruiting)
Study contacts
- Principal investigator: Pascal DEFAYE — CHU Grenoble Alpes
- Study coordinator: Pascal DEFAYE
- Email: PDefaye@chu-grenoble.fr
- Phone: (0)4 76 76 50 48
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.