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

Sponsor
Hospital Clinic of Barcelona
Study ID
NCT05723536
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Partial Left Atrial Isolation — PROCEDURE
    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.
  • Catheter Ablation — PROCEDURE
    Catheter Ablation of Atrial Fibrillation

Study Details

In patients with symptomatic atrial fibrillation (AF), current clinical guidelines recommend ablation for rhythm control. While percutaneous ablation has good results in patients with paroxysmal AF, it is not clear which is the best technique in patients with persistent or long-standing persistent AF. Our group performed the first randomized study of thoracoscopic epicardial ablation vs. endocardial catheter ablation (FAST Trial), which showed better results for epicardial ablation but with a higher rate of complications. Hybrid epicardial and endocardial ablation strategies have recently been described sequentially, showing better results in patients with persistent AF, but 40% of patients are still refractory to ablation. Our study aims to compare the conventional strategy (catheter ablation) with partial electrical isolation of the left atrium endo-epicardially (pulmonary veins, posterior wall and left atrial appendage) in a single procedure in the group of patients most refractory to ablation. Likewise, using magnetic resonance imaging and echocardiography to analyze the atrial remodeling factors that can predict the success and failure of both therapies. Methodology: A 1:1 randomized clinical trial in patients with persistent and long-standing persistent AF in two groups: conventional ablation vs. partial endo-epicardial isolation. Prior to ablation, cardioversion will be performed and functionality and atrial size will be verified by echocardiography and delayed-enhancement magnetic resonance imaging (MRI) will detect the degree of fibrosis and atrial remodeling. During the ablation procedure, a continuous rhythm recording device will be implanted. Likewise, at three months the MRI will be repeated to detect post-ablation fibrosis. At six months the echocardiography will be performed to assess atrial function and size. Main Expected 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

Key Dates

Start date
Apr 1, 2023
Status verified
Feb 2023
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Absence of atrial arrhythmia [ Time Frame: 3-12 months post-surgery ]

Central Contacts

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