Recruiting NCT05411614
Hybrid Ablation of Atrial Fibrillation in Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AtriCure EPi-Sense-AF Guided Coagulation System +/- Atriclip, Endocardial Catheter Ablation.
- Who it may be relevant to
- Registry conditions: Persistent Atrial Fibrillation, Atrial Fibrillation, Persistent, Atrial Arrhythmia, Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomised Controlled Trial Comparing Convergent Hybrid Ablation to Catheter Ablation in Patients With Persistent Atrial Fibrillation and Heart Failure
Overview
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) and Heart Failure
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 and heart failure.
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).
Interventions
- Device AtriCure EPi-Sense-AF Guided Coagulation System +/- Atriclip
Minimally-invasive epicardial ablation +/- left atrial appendage exclusion using an epicardial clip, combined with endocardial radiofrequency catheter ablation - Device Endocardial Catheter Ablation
Standard percutaneous endocardial catheter ablation of atrial fibrillation
Primary outcome measures
- Freedom from persistent atrial arrhythmia after a single procedure (either the completed hybrid ablation or catheter ablation) off Class I or III medications [Time frame: Measured from the end of a 3-month blanking period at 12 and 24 months]
Secondary outcome measures (9)
- Safety Endpoint [Time frame: Measured as early (within 30- days) and late (> 30 days) after each procedure or part of procedure]
- Freedom from any atrial arrhythmia lasting > 30 seconds after a single completed procedure on class I/III medications [Time frame: Measured from the end of a 3- month blanking period at 12 and 24 months]
- Freedom from atrial arrhythmias after any redo procedures (on or off class I or III medications) [Time frame: Measured from the end of a 3- month blanking period at 12 and 24 months]
- To assess left ventricular structural remodelling and change in ventricular function in response to either procedure [Time frame: Pre-procedure and at 12 and 24 months post-procedure]
- To assess left atrial remodelling in response to either technique. [Time frame: Pre-procedure and up to 12 and 24 months post-procedure]
- To evaluate the effects of the interventions on the patient's symptoms and quality of life (EHRA Score) [Time frame: Pre-procedure and at 12 and 24 months post-procedure]
- To evaluate the effects of the interventions on the patient's symptoms and quality of life (NYHA Class). [Time frame: Pre-procedure and at 12 and 24 months post-procedure]
- To evaluate the effects of the interventions on the patient's quality of life (EQ5D) [Time frame: Pre-procedure and at 12 and 24 months post-procedure]
- To evaluate the effects of the interventions on the patient's quality of life (AFEQT) [Time frame: Pre-procedure and at 12 and 24 months post-procedure]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Persistent or Long-standing Persistent AF
- Dilated left atrium (at least moderately dilated)
- Suitable for either procedure
- LVEF < 50%
Exclusion criteria
- Not yet optimised from a medical or lifestyle perspective for AF or heart failure
- 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 the 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, breastfeeding, 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United Kingdom · 7 centers
- Ashford & St Peters Hospital NHS Trust — Chertsey
- Epsom General Hospital — Epsom
- Cromwell Hospital — London
- Royal Surrey County Hospital — London
- St Anthonys Hospital — London
- St Georges at Kingston Hospital — London
- St Georges University of London — London
Publications
- Ahmed O, Behr ER, White S, Momin A, Kaba RA MBChB, FRCP. Convergent Hybrid Ablation Versus Catheter Ablation in Patients With Persistent Atrial Fibrillation and Heart Failure: HALT AF Study Protocol and Rationale for a Multicenter Randomized Controlled Trial. J Am Heart Assoc. 2026 Jun 2;15(11):e047774. doi: 10.1161/JAHA.125.047774. Epub 2026 May 29. PMID 42216292
Identifiers
NCT: NCT05411614 · 2021.0137