Convergent Ablation Plus Left Atrial Appendage Isolation for the Treatment of Persistent Atrial Fibrillation
NCT ID: NCT06165510
Last Updated: 2025-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
48 participants
INTERVENTIONAL
2024-08-02
2026-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Convergent AF Ablation with Left Atrial Appendage Exclusion
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
Epicardial 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.
Standard Endocardial Catheter Ablation
Standard percutaneous endocardial catheter ablation of atrial fibrillation
Standard Endocardial Catheter Ablation
Standard Endocardial Catheter Ablation
Standard Endocardial Catheter Ablation
Standard percutaneous endocardial catheter ablation of atrial fibrillation
Interventions
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Epicardial 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.
Standard Endocardial Catheter Ablation
Standard percutaneous endocardial catheter ablation of atrial fibrillation
Eligibility Criteria
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Inclusion Criteria
* Persistent AF \> 1-year duration
* Left atrium size \< 6cm
* Pts should be able to provide written informed consent.
Exclusion Criteria
* 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
18 Years
80 Years
ALL
Yes
Sponsors
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AtriCure, Inc.
INDUSTRY
Barts & The London NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Syed Ahsan
Role: PRINCIPAL_INVESTIGATOR
Consultant Cardiologist and Electrophysiologist, Barts Health NHS Trust
Locations
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St Bartholomew's Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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320553
Identifier Type: -
Identifier Source: org_study_id
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