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

NCT06165510 | Recruiting DMC FDA Device

• 1 other identifier: 320553
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Catheter ablation; Convergent procedure; Left atrial appendage; Hybrid ablation; Cardiac arrhythmias

Outcome Measures

Primary Outcomes (4)

• Demonstrate trial feasibility with regards to recruitment rate

  Recruitment rate to the Convergent Procedure (with LARIAT) and radiofrequency ablation in the cohort of patients with our specific inclusion criteria will be measured.

  24 months

• A composite of major adverse events (MAE) and complications occurring within 30 days post procedure will be measured.

  Primary safety endpoint was a composite of major adverse events (MAE) and complications occurring within 30 days post procedure. Any of the following endpoints counted as a MAE: death, stroke/transient ischaemic attack, myocardial infarction, pericarditis requiring pericardiocentesis or prolongation of hospital stay or readmission, cardiac perforation/tamponade, bleeding at vascular access site requiring intervention, pneumothorax requiring intervention (after removal of chest drain, symptomatic pulmonary vein stenosis \> 70%, permanent phrenic nerve paralysis, atrio-oesophageal fistula, major vascular complications and infection at surgical or puncture site requiring surgical intervention.

  30 days post procedure

• 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)

  Recurrence of any atrial arrhythmia \> 30 seconds on or off class I / III medications

  Measured from the end of a 3 month blanking period to 12 months post procedure

• Measure improvement in symptoms following convergent ablation

  Measure change in quality of life through the European Heart Rhythm Association (EHRA) patient survey which categorises patients symptoms during physical activity in 4 categories. The higher the class, the greater the severity of symptoms with Class 1 indication no symptoms and Class 4 indicating disabling symptoms with discontinuation of normal daily activity.

  12 months

Secondary Outcomes (3)

• Measure improvement in symptoms following convergent ablation.

  12 months

• Changes in baseline left ventricular ejection fraction (LVEF) in patients with severe left ventricular systolic dysfunction (EF <35%) will be measured.

  12 months

• Measure improvement in NYHA (New York Heart Association) class in patients with NYHA class III to IV following convergent AF ablation.

  12 months

Study Arms (2)

Convergent AF Ablation with Left Atrial Appendage Exclusion

EXPERIMENTAL

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

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

Standard Endocardial Catheter Ablation

ACTIVE COMPARATOR

Standard Endocardial Catheter Ablation

Procedure: Standard Endocardial Catheter Ablation

Interventions

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

Convergent AF Ablation with Left Atrial Appendage Exclusion

Standard Endocardial Catheter Ablation PROCEDURE

Standard percutaneous endocardial catheter ablation of atrial fibrillation

Convergent AF Ablation with Left Atrial Appendage Exclusion; Standard Endocardial Catheter Ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• AtriCure, Inc.: collaborator

Study Sites (1)

St Bartholomew's Hospital

London, EC1A 4AS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Study Officials

• Syed Ahsan

  Consultant Cardiologist and Electrophysiologist, Barts Health NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Syed Ahsan

CONTACT

020 7377 7000; syedahsan@nhs.net

Shahana Hussain

CONTACT

020 7377 7000; shahana.hussain2@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical study with 1:1 recruitment in each arm - Convergent AF Ablation with LARIAT procedure versus endocardial catheter ablation.

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: December 11, 2023
• Study Start: August 2, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)