Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID06165510

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

Led by Barts & The London NHS Trust · Updated on 2026-05-20

48

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

Sponsors

B

Barts & The London NHS Trust

Lead Sponsor

A

AtriCure, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of a combined approach called the Convergent procedure with the LARIAT device compared to standard catheter ablation in patients with long-standing persistent atrial fibrillation (AF). This study focuses on improving treatment outcomes for persistent AF, which is a common heart rhythm disorder linked to stroke and heart failure. Current treatments have moderate success, so this trial aims to explore a new minimally invasive method that may enhance patient quality of life and reduce hospital readmissions. The Convergent procedure involves two stages: first, a minimally invasive surgical ablation targeting the back wall of the left atrium combined with isolating the left atrial appendage using the LARIAT device; second, a catheter ablation performed inside the heart to confirm and complete the lesion formation. Patients are randomly assigned to receive either this two-stage Convergent ablation with LARIAT or the standard endocardial catheter ablation treatment. Participants will be closely monitored for safety and treatment success, including tracking adverse events within 30 days and freedom from atrial arrhythmias over 12 months after a 3-month recovery period. Researchers will also assess symptom improvements, heart function changes, and heart failure status during the year following treatment. The study includes a recruitment feasibility assessment over 24 months and continues until October 2026.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years and under 80 years
  • Persistent atrial fibrillation lasting more than 1 year
  • Left atrium size less than 6 cm
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Currently enrolled in another investigational study except observational registries without treatments
  • Reversible or transient cause of atrial fibrillation
  • Absence of left atrial appendage or previous surgical ligation of the appendage
  • Previous cardiac or abdominal surgery
  • Contraindication to anticoagulation therapy
  • Hypertrophic cardiomyopathy
  • Significant valve disease
  • Previous catheter or surgical ablation for atrial fibrillation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Procedure day plus immediate recovery period

Participants undergo the assigned ablation procedure which may involve a two-stage minimally invasive epicardial ablation with left atrial appendage exclusion followed by endocardial catheter ablation, or standard endocardial catheter ablation.

1 to 2 visits depending on procedure stage

Follow-up

Duration - 12 months

Participants are monitored for safety, efficacy, and symptom improvement after the ablation procedure.

Regular follow-up visits during 12 months post procedure

Trial Site Locations

Total: 1 location

1

St Bartholomew's Hospital

London, United Kingdom, EC1A 4AS

Actively Recruiting

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Research Team

S

Syed Ahsan

S

Shahana Hussain

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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