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

Sponsor: Barts & The London NHS Trust

NCT ID: NCT06165510

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Epicardial AF ablation using AtriCure EPi-Sense-AF Guided Coagulation System with Left Atrial Appendage Exclusion using the AtriCure LARIAT Suture Delivery Device. (device), Standard Endocardial Catheter Ablation (procedure)
How long the study runs
Study runs about 27 months (dates as stated)
About the drug or intervention
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. · Standard Endocardial Catheter Ablation — procedure: Standard percutaneous endocardial catheter ablation of atrial fibrillation
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 80 Years
Who
All
Number of participants
48
Started
2024-08-02
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for persistent atrial fibrillation
  • • NA - 48 participants
  • • 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)

Who can take part?

  • • Ages 18 Years to 80 Years
  • • Diagnosed with persistent atrial fibrillation

Where?

  • • London - St Bartholomew's Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

More detail

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.

Persistent Atrial FibrillationAtrial Fibrillation, PersistentAtrium; FibrillationAtrial Arrhythmia

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 80 Years
  • Who can join: All genders

What the study is looking for

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

Who cannot take part

  • ✗Subjects currently enrolled in another investigational study except in case of observational registry with no...
  • ✗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 heart surgery or abdominal surgery.
  • ✗Subject has safety concern to anticoagulation.
See the full 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

Where Is This Study? (1 UK site)

St Bartholomew's Hospital

London EC1A 4AS, United Kingdom

Recruiting
Site contact (verified)
Syed AhsanPrincipal Investigator

How to Get in Touch

Syed Ahsan

Sponsor contact

CONTACT

020 7377 7000 syedahsan@nhs.net

Shahana Hussain

Sponsor contact

CONTACT

020 7377 7000 shahana.hussain2@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2026-06