Monitoring the safety and effectiveness of leadless pacemakers in France

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Evaluating tricuspid regurgitation progression in pacemaker patients

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.