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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation, Persistent; Persistent Atrial Fibrillation; Atrial Arrhythmia; Atrium; Fibrillation
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Syed Ahsan; Phone Number: 020 7377 7000; Email: syedahsan@nhs.net
• Study Contact Backup: Name: Shahana Hussain; Phone Number: 020 7377 7000; Email: shahana.hussain2@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom, EC1A 4AS
    • St Bartholomew's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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	Procedure: Standard Endocardial Catheter Ablation; Standard percutaneous endocardial catheter ablation of atrial fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure improvement in symptoms following convergent ablation.	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.	12 months
Changes in baseline left ventricular ejection fraction (LVEF) in patients with severe left ventricular systolic dysfunction (EF <35%) will be measured.	Assessment of LVEF via transthoracic echocardiogram at baseline and transthoracic echocardiogram at 12 months post procedure.	12 months
Measure improvement in NYHA (New York Heart Association) class in patients with NYHA class III to IV following convergent AF ablation.	Assessment of heart failure symptoms and functional status via clinic review at baseline and 12 months post-procedure.	12 months

Collaborators and Investigators

• Sponsor: Barts & The London NHS Trust
• Collaborators: AtriCure, Inc.
• Investigators: Principal Investigator: Syed Ahsan, Consultant Cardiologist and Electrophysiologist, Barts Health NHS Trust

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Estimated): December 11, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Hybrid ablation; Left atrial appendage; Catheter ablation; Cardiac arrhythmias; Convergent procedure
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: 320553

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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