RecruitingNot ApplicableNCT06165510

Convergent Ablation Plus Left Atrial Appendage Isolation for the Treatment of Persistent Atrial Fibrillation

Sponsor

Barts & The London NHS Trust

Enrollment

48 participants

Start Date

Aug 2, 2024

Study Type

INTERVENTIONAL

Conditions

Atrial Arrhythmia Persistent Atrial Fibrillation Atrial Fibrillation, Persistent Atrium; Fibrillation

Summary

A randomised controlled clinical trial to assess efficacy of convergent ablation with the LARIAT procedure, as compared to standard endocardial catheter ablation in patients with long-standing persistent atrial fibrillation (AF).

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

Age \> 18 years; \< 80 years
Persistent AF \> 1-year duration
Left atrium size \< 6cm
Pts should be able to provide written informed consent.

Exclusion Criteria8

Subjects currently enrolled in another investigational study except in case of observational registry with no associated treatments.
Subject has a reversible cause of AF or transient AF
Subject is absent of LAA or if the LAA is previously surgically ligated
Subject has had previous cardiac surgery or abdominal surgery.
Subject has contraindication to anticoagulation.
Patients with hypertrophic cardiomyopathy.
Patients with significant valve disease.
Subject has had previous catheter or surgical ablation

Interventions

DEVICEEpicardial AF ablation using AtriCure EPi-Sense-AF Guided Coagulation System with Left Atrial Appendage Exclusion using the AtriCure LARIAT Suture Delivery Device.

2 stage procedure - minimally-invasive epicardial ablation with left atrial appendage exclusion using LARIAT procedure via a subxiphoid incision. This is then combined with endocardial radiofrequency catheter ablation in a separate staged procedure.

PROCEDUREStandard Endocardial Catheter Ablation

Standard percutaneous endocardial catheter ablation of atrial fibrillation