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NCT Number: NCT06165510

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

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).

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Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Arrhythmia Atrial Fibrillation Atrial Fibrillation, Persistent Atrium; Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Bartholomew's Hospital

London, EC1A 4AS, United Kingdom

Location status: Recruiting

Location contact

Nikolaos Papageorgiou

SUB_INVESTIGATOR

Syed Ahsan

CONTACT

[email protected]

020 7377 7000

Syed Ahsan

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard Endocardial Catheter Ablation

Procedure

Standard percutaneous endocardial catheter ablation of atrial fibrillation

Primary outcomes

  1. Demonstrate trial feasibility with regards to recruitment rate

    Time frame: 24 months

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

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

    Time frame: 30 days post procedure

    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.

  3. 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)

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

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

  4. Measure improvement in symptoms following convergent ablation

    Time frame: 12 months

    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.

Secondary outcomes

  1. Measure improvement in symptoms following convergent ablation.

    Time frame: 12 months

    To measure improvement in quality of life assessment measured through the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire) to be performed at baseline, 6 months and 12 months post procedure. This survey employs the use of 20 questions regarding symptoms, effect on daily activities, treatment concerns and treatment satisfaction to generate a score from 0 - 100. The lower the score, the more severe the disability with score 0 indicating complete disability and score 100 indicating no disability or limitation in daily activities.

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

    Time frame: 12 months

    Assessment of LVEF via transthoracic echocardiogram at baseline and transthoracic echocardiogram at 12 months post procedure.

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

    Time frame: 12 months

    Assessment of heart failure symptoms and functional status via clinic review at baseline and 12 months post-procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Shahana Hussain

CONTACT

[email protected]

020 7377 7000

Syed Ahsan

CONTACT

[email protected]

020 7377 7000

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Collaborators

  • AtriCure, Inc.

Registry information

Acronym: CLIP-AF

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2023
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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