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

NCT05723536 | Unknown Phase 3

• 1 other identifier: HCB/2022/1059
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation; Persistent Atrial Fibrillation; Arrythmia

Outcome Measures

Primary Outcomes (1)

• Absence of atrial arrhythmia

  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 Outcomes (3)

• 90% reduction in baseline AF burden

  3-12 months post-surgery

• Pre-procedure atrial remodeling

  3-months pre-surgery to 12 months post-surgery

• Post-procedure atrial remodeling

  3-12 months post-surgery

Study Arms (2)

PLAI (Partial Left Atrial Isolation)

EXPERIMENTAL

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

CA (Catheter Ablation)

ACTIVE COMPARATOR

Conventional catheter ablation of persistent atrial fibrillation.

Procedure: Catheter Ablation

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.

PLAI (Partial Left Atrial Isolation)

Catheter Ablation PROCEDURE

Catheter Ablation of Atrial Fibrillation

CA (Catheter Ablation)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Spain

RECRUITING

Related Publications (12)

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• Maesen B, Pison L, Vroomen M, Luermans JG, Vernooy K, Maessen JG, Crijns HJ, La Meir M. Three-year follow-up of hybrid ablation for atrial fibrillation. Eur J Cardiothorac Surg. 2018 Apr 1;53(suppl_1):i26-i32. doi: 10.1093/ejcts/ezy117.

  PMID: 29590387 BACKGROUND

• DeLurgio DB, Crossen KJ, Gill J, Blauth C, Oza SR, Magnano AR, Mostovych MA, Halkos ME, Tschopp DR, Kerendi F, Taigen TL, Shults CC, Shah MH, Rajendra AB, Osorio J, Silver JS, Hook BG, Gilligan DM, Calkins H. Hybrid Convergent Procedure for the Treatment of Persistent and Long-Standing Persistent Atrial Fibrillation: Results of CONVERGE Clinical Trial. Circ Arrhythm Electrophysiol. 2020 Dec;13(12):e009288. doi: 10.1161/CIRCEP.120.009288. Epub 2020 Nov 13.

  PMID: 33185144 BACKGROUND

• Yorgun H, Canpolat U, Kocyigit D, Coteli C, Evranos B, Aytemir K. Left atrial appendage isolation in addition to pulmonary vein isolation in persistent atrial fibrillation: one-year clinical outcome after cryoballoon-based ablation. Europace. 2017 May 1;19(5):758-768. doi: 10.1093/europace/eux005.

  PMID: 28340073 BACKGROUND

• Whitlock RP, Belley-Cote EP, Paparella D, Healey JS, Brady K, Sharma M, Reents W, Budera P, Baddour AJ, Fila P, Devereaux PJ, Bogachev-Prokophiev A, Boening A, Teoh KHT, Tagarakis GI, Slaughter MS, Royse AG, McGuinness S, Alings M, Punjabi PP, Mazer CD, Folkeringa RJ, Colli A, Avezum A, Nakamya J, Balasubramanian K, Vincent J, Voisine P, Lamy A, Yusuf S, Connolly SJ; LAAOS III Investigators. Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke. N Engl J Med. 2021 Jun 3;384(22):2081-2091. doi: 10.1056/NEJMoa2101897. Epub 2021 May 15.

  PMID: 33999547 BACKGROUND

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  PMID: 29971492 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Manuel Castellà, MD PhD

CONTACT

+34932275515; mcaste@clinic.cat

Laia Hernández, MSc

CONTACT

+34932275733; lahernandez@clinic.cat

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomized clinical trial in patients with persistent and long-standing persistent AF in two groups: conventional ablation vs partial endo-epicardial isolation.

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 10, 2023
• Study Start: April 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)