Hybrid AbLaTion of Atrial Fibrillation (HALT-AF)

St. George's Hospital, London

Status: Enrolling

Conditions: Atrial Fibrillation, Persistent; Atrial Fibrillation; Persistent Atrial Fibrillation; Atrial Arrhythmia

Treatments: Device: Endocardial Catheter Ablation; Device: AtriCure EPi-Sense-AF Guided Coagulation System +/- Atriclip

Study type: Interventional

Funder types: Other

Identifiers

NCT05411614

2021.0137

Details and patient eligibility

About

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)

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Convergent Hybrid Ablation with Left Atrial Appendage Exclusion

Experimental group

Description:

Staged Convergent Hybrid Ablation Procedure Stage 1 - Minimally-Invasive Surgical Epicardial Ablation Procedure +/- concomitant LAA exclusion. Stage 2 - Endocardial Catheter Ablation

Treatment:

Device: AtriCure EPi-Sense-AF Guided Coagulation System +/- Atriclip

Device: Endocardial Catheter Ablation

Standard Endocardial Catheter Ablation

Active Comparator group

Description:

Standard endocardial catheter ablation

Treatment:

Device: Endocardial Catheter Ablation