Clinical trial NCT06165510: Convergent Ablation Plus Left Atrial Appendage Isolation for the Treatment of Persistent Atrial Fibrillation
Official title: Convergent Ablation Plus Left Atrial Appendage Isolation for the Treatment of Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Persistent Atrial Fibrillation
Atrial Fibrillation, Persistent
Atrium; Fibrillation
Atrial Arrhythmia
Keywords: Catheter ablation
Convergent procedure
Left atrial appendage
Hybrid ablation
Cardiac arrhythmias
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: AtriCure, Inc.
First posted: 2023-12-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical study with 1:1 recruitment in each arm - Convergent AF Ablation with LARIAT procedure versus endocardial catheter ablation.
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Demonstrate trial feasibility with regards to recruitment rate
timeFrame: 24 months
measure: A composite of major adverse events (MAE) and complications occurring within 30 days post procedure will be measured.
timeFrame: 30 days post procedure
measure: Success or failure at 12 months of persistent AF patients to be free of: Atrial arrhythmia (classed as documentation of atrial fibrillation, atrial flutter or atrial tachycardia lasting for more than 30 seconds)
timeFrame: Measured from the end of a 3 month blanking period to 12 months post procedure
measure: Measure improvement in symptoms following convergent ablation
timeFrame: 12 months
Secondary outcomes:
measure: Measure improvement in symptoms following convergent ablation.
timeFrame: 12 months
measure: Changes in baseline left ventricular ejection fraction (LVEF) in patients with severe left ventricular systolic dysfunction (EF <35%) will be measured.
timeFrame: 12 months
measure: Measure improvement in NYHA (New York Heart Association) class in patients with NYHA class III to IV following convergent AF ablation.
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
Study officials:
affiliation: Consultant Cardiologist and Electrophysiologist, Barts Health NHS Trust
name: Syed Ahsan
role: PRINCIPAL_INVESTIGATOR
References: