NCT06747091

ARIADNE Clinical Trial

Adjuvant Ablation for PeRsistent AtrIal FibrillAtion Using Dual ENergy LatticE Tip Catheter: ARIADNE-Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Stavros E Mountantonakis · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A prospective multi-arm parallel group randomized clinical trial to compare the efficacy of three ablation strategies in patients with persistent atrial fibrillation using using a lattice-tip catheter that can switch between RFA and PFA energy. The incremental benefit of posterior wall isolation (PWI) and mitral isthmus ablation may contribute to greater freedom from atrial fibrillation at twelve months.

Detailed description

This is a prospective randomized clinical trial. Patients will undergo catheter ablation for persistent AF using a lattice-tip catheter that can switch between RFA and PFA energy. Enrolled patients will be randomized to one of three ablation strategies: 1. Pulmonary vein isolation using PFA energy 2. Pulmonary vein isolation and posterior wall isolation using PFA energy 3. Pulmonary vein isolation and posterior wall isolation (PFA) and mitral isthmus ablation using RFA or PFA energy. Patients will receive an implantable loop recorder prior to, during or post index ablation procedure for continuous monitoring for clinical recurrence of AF/AT/AFL

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Catheter Ablation	This is a prospective randomized clinical trial. Patients will undergo catheter ablation for persistent AF using a lattice-tip catheter that can switch between RFA and PFA energy. Enrolled patients will be randomized to one of three ablation strategies:

Timeline

• Start date: 2025-03-18
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2024-12-24
• Last updated: 2025-09-15

Locations

3 sites across 1 country: United States