Evaluating early pulmonary vein isolation for elderly patients with atrial fibrillation

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 study investigates the effectiveness of early pulmonary vein isolation (PVI) compared to conventional treatment in patients over 75 years old diagnosed with atrial fibrillation. The trial aims to determine if PVI can provide better outcomes in terms of rhythm control while minimizing the side effects associated with antiarrhythmic medications. Participants will be randomly assigned to receive either the PVI procedure or standard care with antiarrhythmic drugs. The study focuses on a population that may benefit from a less invasive and more effective treatment option for managing atrial fibrillation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Man or woman aged 75 and over.
* Paroxysmal AF or early recurrent or persistent paroxysmal AF first diagnosed less than 12 months ago.
* Patient who consented to participate in the study.
* Patient affiliated to a social security system.

Exclusion Criteria:

* Indication of cardiac pacing or defibrillation at baseline.
* History of valve replacement, atrial occlusion or exclusion.
* History of AF ablation.
* Contraindication to anticoagulation or an invasive procedure.
* Significant heart disease (structural with alteration of LVEF \<35%, congenital heart disease, hypertrophic heart disease with wall of more than 15 mm, revascularized coronary syndrome less than 3 months old).
* Stroke less than 6 months old.
* Uncontrolled dysthyroidism.
* Chronic renal failure (CKD - eGFR \<30 µMol/L).
* Patient under curatorship, guardianship, safeguard of justice.
* Life expectancy less than 24 months.
* Participation in another therapeutic trial likely to impact the study evaluation criteria.
* Severe cognitive impairment noted in history.
* Lack of understanding of the study.

Where it's running

• Nantes University Hospital
  Nantes, Loire Atlantique, France Recruiting

Study contacts

• Principal investigator: Jean-Baptiste Gourraud, MD — Nantes University Hospital
• Study coordinator: Jean-Baptiste Gourraud, MD
• Email: JeanBaptiste.GOURRAUD@chu-nantes.fr
• Phone: 0240165143

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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.