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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Results: The expected results include: 1. an improvement in the rate of patients with no atrial arrhythmias recurrence in patients undergoing endo-epicardial ablation; 2. a lower AF burden in patients undergoing endo-epicardial ablation who have had recurrence; 3. To know the degree of atrial fibrosis associated with the success/failure of each technique; 4. To know the degree of fibrosis that both techniques produce; 5. To know the degree of ventricular function associated with the success/failure of each technique; 6. To know the degree of potentially lost atrial function; 7. To Compare the safety of both techniques

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Patients between the ages of 18 and 75, both inclusive, at the time of the consent date.

• Patients with persistent atrial fibrillation refractory to at least one antiarrhythmic drug (Class I or III).

• Signature of written informed consent.

Locations
Other Locations
Spain
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Contact Information
Primary
Manuel Castellà, MD PhD
mcaste@clinic.cat
+34932275515
Backup
Laia Hernández, MSc
lahernandez@clinic.cat
+34932275733
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 80
Treatments
Experimental: PLAI (Partial Left Atrial Isolation)
Partial electrical isolation of the left atrium endo-epicardially (pulmonary veins, posterior wall and left atrial appendage) and left atrial appendage isolation using Atriclip (Atricure, Mason OH, USA) in a single procedure in patients with persistent atrial fibrillation.
Active_comparator: CA (Catheter Ablation)
Conventional catheter ablation of persistent atrial fibrillation.
Related Therapeutic Areas
Sponsors
Leads: Hospital Clinic of Barcelona

This content was sourced from clinicaltrials.gov