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Convergent Ablation Plus Left Atrial Appendage Isolation for the Treatment of Persistent Atrial Fibrillation (CLIP-AF)

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ClinicalTrials.gov Identifier: NCT06165510
Recruitment Status : Not yet recruiting
First Posted : December 11, 2023
Last Update Posted : December 11, 2023
Sponsor:
Collaborator:
AtriCure, Inc.
Information provided by (Responsible Party):
Barts & The London NHS Trust

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).

Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Atrial Fibrillation, Persistent Atrium; Fibrillation Atrial Arrhythmia 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Clinical study with 1:1 recruitment in each arm - Convergent AF Ablation with LARIAT procedure versus endocardial catheter ablation.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Convergent Ablation Plus Left Atrial Appendage Isolation for the Treatment of Persistent Atrial Fibrillation
Estimated Study Start Date : January 2024
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Convergent AF Ablation with Left Atrial Appendage Exclusion

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.
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.

Procedure: Standard Endocardial Catheter Ablation
Standard percutaneous endocardial catheter ablation of atrial fibrillation

Active Comparator: Standard Endocardial Catheter Ablation
Standard Endocardial Catheter Ablation
Procedure: Standard Endocardial Catheter Ablation
Standard percutaneous endocardial catheter ablation of atrial fibrillation




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06165510


Contacts
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Contact: Syed Ahsan 020 7377 7000 syedahsan@nhs.net
Contact: Shahana Hussain 020 7377 7000 shahana.hussain2@nhs.net

Locations
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United Kingdom
St Bartholomew's Hospital
London, United Kingdom, EC1A 4AS
Sponsors and Collaborators
Barts & The London NHS Trust
AtriCure, Inc.
Investigators
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Principal Investigator: Syed Ahsan Consultant Cardiologist and Electrophysiologist, Barts Health NHS Trust
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Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT06165510    
Other Study ID Numbers: 320553
First Posted: December 11, 2023    Key Record Dates
Last Update Posted: December 11, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Barts & The London NHS Trust:
Catheter ablation
Convergent procedure
Left atrial appendage
Hybrid ablation
Cardiac arrhythmias
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes