Hybrid AbLaTion of Atrial Fibrillation

Not Applicable

Recruiting

• Conditions: Persistent Atrial Fibrillation; Atrial Fibrillation, Persistent; Atrial Arrhythmia; Atrial Fibrillation
• Interventions: Device: Endocardial Catheter Ablation; Device: AtriCure EPi-Sense-AF Guided Coagulation System +/- Atriclip

• Registration Number: NCT05411614
• Lead Sponsor: St. George's Hospital, London

Brief Summary

A randomised controlled trial to assess the efficacy of staged hybrid ablation when compared with standard catheter ablation in patients with non-paroxysmal atrial fibrillation (AF)

Detailed Description

The objective of this randomized study is to evaluate the safety and efficacy of Convergent hybrid ablation when compared to standard catheter ablation in patients with non-paroxysmal AF.

Patients will be randomised in a 1:1 ratio. The primary efficacy endpoint will be freedom from persistent atrial arrhythmia (measured from the end of a 3-month blanking period up to 24 months (12 and 24 months).

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-06-06
• Study First Posted: 2022-06-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Primary Completion: 2025-05
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age ≥ 18 years
• Persistent or Long-standing Persistent AF
• Dilated left atrium
• Suitable for either procedure

Exclusion Criteria

• Unable to provide written consent
• Previous open-heart surgery
• Active infection, oesophageal ulcer stricture or oesophageal varices
• Prior catheter ablation of atrial fibrillation (prior ablation for atrial flutter / supraventricular tachycardia or ventricular arrhythmia acceptable)
• Contraindication to anticoagulation, or active thrombus in left atrium despite therapeutic anticoagulation
• Severe valvular heart disease
• Unstable coronary artery disease
• Uncontrolled ventricular arrhythmia
• Heart attack or stroke within the last 90 days
• Pregnant, breast-feeding, or women of childbearing age who plan to get pregnant within six months
• Severe concomitant condition or presence of an implanted device that would preclude the patient from undergoing trial procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Endocardial Catheter Ablation	Endocardial Catheter Ablation	Standard endocardial catheter ablation
Convergent Hybrid Ablation with Left Atrial Appendage Exclusion	AtriCure EPi-Sense-AF Guided Coagulation System +/- Atriclip	Staged Convergent Hybrid Ablation Procedure Stage 1 - Minimally-Invasive Surgical Epicardial Ablation Procedure +/- concomitant LAA exclusion. Stage 2 - Endocardial Catheter Ablation
Convergent Hybrid Ablation with Left Atrial Appendage Exclusion	Endocardial Catheter Ablation	Staged Convergent Hybrid Ablation Procedure Stage 1 - Minimally-Invasive Surgical Epicardial Ablation Procedure +/- concomitant LAA exclusion. Stage 2 - Endocardial Catheter Ablation

Primary Outcome Measures

Name	Time	Method
Freedom from persistent atrial arrhythmia after a single procedure (either the completed hybrid ablation or catheter ablation) off Class I or III medications	Measured from the end of a 3-month blanking period at 12 and 24 months	Recurrence of persistent atrial arrhythmia during follow-up months).

Secondary Outcome Measures

Name	Time	Method
To assess left ventricular structural remodelling and change in ventricular function in response to either procedure	Pre-procedure and at 12 and 24 months post-procedure	Left ventricular ejection fraction as recorded on transthoracic echocardiography (TTE)
To evaluate the effects of the interventions on the patient's quality of life (EQ5D)	Pre-procedure and at 12 and 24 months post-procedure	Change in EuroQol Quality of life Score (EQ5D)
Safety Endpoint	Measured as early (within 30- days) and late (> 30 days) after each procedure or part of procedure	Safety endpoint of severe and non-severe complications as defined in the protocol
Freedom from any atrial arrhythmia lasting > 30 seconds after a single completed procedure on class I/III medications	Measured from the end of a 3- month blanking period at 12 and 24 months	Recurrence of any atrial arrhythmia \> 30 seconds on or off class I / III medications, considering any repeat ablation procedures
Freedom from atrial arrhythmias after any redo procedures (on or off class I or III medications)	Measured from the end of a 3- month blanking period at 12 and 24 months	Recurrence of any atrial arrhythmia \> 30 seconds on or off class I / III medications, considering any repeat ablation procedures
To evaluate the effects of the interventions on the patient's quality of life (AFEQT)	Pre-procedure and at 12 and 24 months post-procedure	Change in Atrial Fibrillation Effect on Quality of Life Score (AFEQT)
To assess left atrial remodelling in response to either technique.	Pre-procedure andat 12 and 24 months post-procedure	Left atrial size on Echocardiography
To evaluate the effects of the interventions on the patient's symptoms and quality of life (EHRA Score)	Pre-procedure and at 12 and 24 months post-procedure	Change in European Heart Rhythm Association (EHRA) AF Symptom score
To evaluate the effects of the interventions on the patient's symptoms and quality of life (NYHA Class).	Pre-procedure and at 12 and 24 months post-procedure	Change in New York Heart Association (NYHA) class

Trial Locations

Locations (1)

St Georges University of London; 🇬🇧 London, United Kingdom