Evaluating early pulmonary vein isolation for elderly patients with atrial fibrillation

Prospective Multicenter Randomized and Controlled Study Evaluating the Benefit of Early Pulmonary Vein Isolation Compared to Usual Treatment in Patients Aged Over 75 Years and Presenting With Atrial Fibrillation

This study tests if an early procedure called pulmonary vein isolation can help older patients with atrial fibrillation feel better compared to standard treatment with medications.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 294 (estimated)
• Ages: 75 Years and up
• Sex: All
• Sponsor: Nantes University Hospital (other)
• Locations: 1 site (Nantes, Loire Atlantique)
• Trial ID: NCT06322017 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 75 and older with paroxysmal or early recurrent atrial fibrillation diagnosed within the last 12 months.

Not a fit: Patients with significant heart disease, recent strokes, or contraindications to anticoagulation or invasive procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved heart rhythm management and reduced complications for elderly patients with atrial fibrillation.

How similar studies have performed: While the use of pulmonary vein isolation has shown promise in younger populations, this specific approach in elderly patients is novel and has not been extensively tested in dedicated randomized studies.

Eligibility criteria

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 this trial is running

Nantes, Loire Atlantique

• 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

Conditions: Atrial Fibrillation, Atrial fibrillation, Pulmonary vein isolation, Elderly Conventional management, Frailty