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

February 22, 2023 updated by: Hospital Clinic of Barcelona

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic De Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: 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.
Procedure: Catheter Ablation
Catheter Ablation of Atrial Fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absence of atrial arrhythmia
Time Frame: 3-12 months post-surgery
Success or failure to be free of atrial arrhythmias (AF/AT/AFL) in the absence of class I and III antiarrhythmic drugs, or with the same antiarrhythmic treatment prior to study inclusion, after the 3-month blank period, during 12 months after the procedure and measured by loop recorder.
3-12 months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
90% reduction in baseline AF burden
Time Frame: 3-12 months post-surgery
90% reduction in baseline AF burden in the absence of a new/increased dose of class I/III antiarrhythmic medication, as measured by implantable ECG recorder.
3-12 months post-surgery
Pre-procedure atrial remodeling
Time Frame: 3-months pre-surgery to 12 months post-surgery
Pre-procedure atrial remodelling by MRI measuring fibrosis grade. Pre-procedure atrial remodelling by echocardiogram measuring size and function. Both measurements are in relation to primary endpoint success/failure in both groups.
3-months pre-surgery to 12 months post-surgery
Post-procedure atrial remodeling
Time Frame: 3-12 months post-surgery
Post-procedure atrial remodelling by MRI measuring fibrosis grade. Post-procedure atrial remodelling by echocardiogram measuring size and function. Both measurements are in relation to primary endpoint success/failure in both groups.
3-12 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

February 2, 2023

First Submitted That Met QC Criteria

February 2, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB/2022/1059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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