Convergent Ablation Plus Left Atrial Appendage Isolation for the Treatment of Persistent Atrial Fibrillation (CLIP-AF)

Barts & The London NHS Trust

Status: Enrolling

Conditions: Atrial Fibrillation, Persistent; Persistent Atrial Fibrillation; Atrial Arrhythmia; Atrium; Fibrillation

Treatments: Device: Epicardial AF ablation using AtriCure EPi-Sense-AF Guided Coagulation System with Left Atrial Appendage Exclusion using the AtriCure LARIAT Suture Delivery Device.; Procedure: Standard Endocardial Catheter Ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06165510

320553

Details and patient eligibility

About

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).

Full description

Atrial Fibrillation is the commonest arrhythmia and is a major cause of morbidity and mortality, often causative in ischaemic strokes and compounded by heart failure. Treatment options are limited for persistent long-standing AF (PeAF), with pulmonary vein isolation by endocardial ablation being insufficient and further additive endocardial lesions with repeated ablations yield mixed results resultant in further atrial arrhythmias. Currently success rates for catheter ablation are moderate at 40 to 70% in a single procedure.

If this was improved, patient quality of life and readmission rates would significantly improve as well as a reduction in anti-arrhythmic drug use.

The Convergent procedure - is a two stage minimally invasive hybrid approach. The first stage employs surgical ablation to the posterior wall of the left atrium in combination with the LARIAT procedure to isolate the left atrium appendage (LAA). The second stage involves endocardial catheter ablation to confirm the surgical ablation lesions, and perform further endocardial catheter ablation to leverage both epicardial and endocardial lesions to create durable, transmural lesions.

Patients with long-standing persistent AF will be randomised in a 1:1 ratio to either the Convergent ablation with the LARIAT procedure or the standard endocardial catheter ablation.

This feasibility study would assess recruitment to the trial, safety and efficacy of the Convergent procedure, in combination with a left atrial appendage system.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Convergent AF Ablation with Left Atrial Appendage Exclusion

Experimental group

Description:

Two Staged Convergent AF Ablation Procedure Stage 1 - Minimally Invasive Surgical Epicardial Ablation Procedure with concomitant LAA exclusion (LARIAT procedure) Stage 2 - Percutaneous Endocardial Catheter Ablation

Treatment:

Procedure: Standard Endocardial Catheter Ablation

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

Standard Endocardial Catheter Ablation

Active Comparator group

Description:

Standard Endocardial Catheter Ablation

Treatment:

Procedure: Standard Endocardial Catheter Ablation