Comparing two methods for treating persistent atrial fibrillation

PLAI-AF Trial: Hybrid Endo-epicardial Partial Left Atrial Isolation vs. Endocardial Ablation in Patients With Persistent Atrial Fibrillation

This study is testing whether a new treatment method for persistent atrial fibrillation works better than the standard approach for patients who haven't found relief with medication.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hospital Clinic of Barcelona (Academic / other)
• Locations: 1 site (Barcelona)
• Trial ID: NCT05723536 on ClinicalTrials.gov

What this trial studies

This trial aims to evaluate the effectiveness of hybrid endo-epicardial partial left atrial isolation versus conventional endocardial catheter ablation in patients with persistent atrial fibrillation. The study is designed for patients who have not responded to at least one antiarrhythmic drug and seeks to determine which technique offers better outcomes in terms of rhythm control. By comparing these two approaches, the trial hopes to provide insights into the most effective treatment for this challenging condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with persistent atrial fibrillation that has not responded to at least one antiarrhythmic medication.

Not a fit: Patients with persistent atrial fibrillation lasting more than four years or those with significant heart conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with persistent atrial fibrillation, potentially reducing symptoms and improving quality of life.

How similar studies have performed: Previous studies have shown promising results with hybrid ablation techniques, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Patients between the ages of 18 and 75, both inclusive, at the time of the consent date.
2. Patients with persistent atrial fibrillation refractory to at least one antiarrhythmic drug (Class I or III).
3. Signature of written informed consent.

Exclusion Criteria:

1. Persistent atrial fibrillation of more than 4 years.
2. Moderate to severe valvular heart disease.
3. Severe atrial dilatation (left appendage AP diameter \> 55 mm or \> 50ml/m2).
4. Patients requiring concomitant cardiac surgery or with previous cardiac surgery.
5. Left ventricular ejection fraction \<40%.
6. History of pericarditis.
7. Previous stroke.
8. Presence of active infection or sepsis, esophageal ulcer stricture and/or esophageal varices.
9. Patients with renal dysfunction defined as GFR less than or equal to 40 ml/min/m2.
10. Contraindication for chronic anticoagulation.
11. Patients who have undergone prior left atrial catheter ablation for atrial fibrillation or who are receiving treatment for ventricular arrhythmia.
12. Patients with severe chronic obstructive pulmonary disease considered GOLD III.
13. Patients with active neoproliferative disease or other concomitant disease where the medical team considers that ablation places the patient at unacceptable risk.
14. Pregnant, lactating women.
15. Patients who have previously presented allergic reactions to gadolinium.
16. Patients with claustrophobia that makes it impossible to perform nuclear magnetic resonance.

Where this trial is running

Barcelona

• Hospital Clínic de Barcelona — Barcelona, Spain (Recruiting)

Study contacts

• Study coordinator: Manuel Castellà, MD PhD

Conditions Atrial Fibrillation; Persistent Atrial Fibrillation; Arrythmia