Hybrid Ablation of Atrial Fibrillation in Heart Failure
HALT AF
A Randomised Controlled Trial Comparing Convergent Hybrid Ablation to Catheter Ablation in Patients With Persistent Atrial Fibrillation and Heart Failure
1 other identifier
interventional
120
1 country
7
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) and Heart Failure
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2022
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2022
CompletedFirst Posted
Study publicly available on registry
June 9, 2022
CompletedStudy Start
First participant enrolled
June 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
ExpectedNovember 28, 2025
November 1, 2025
3.9 years
May 20, 2022
November 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Freedom from persistent atrial arrhythmia after a single procedure (either the completed hybrid ablation or catheter ablation) off Class I or III medications
Recurrence of persistent atrial arrhythmia during follow-up months).
Measured from the end of a 3-month blanking period at 12 and 24 months
Secondary Outcomes (9)
Safety Endpoint
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
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)
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
Pre-procedure and at 12 and 24 months post-procedure
To assess left atrial remodelling in response to either technique.
Pre-procedure and up to 12 and 24 months post-procedure
- +4 more secondary outcomes
Study Arms (2)
Convergent Hybrid Ablation +/- Left Atrial Appendage Exclusion
EXPERIMENTALStaged Convergent Hybrid Ablation Procedure Stage 1 - Minimally-Invasive Surgical Epicardial Ablation Procedure +/- concomitant LAA exclusion. Stage 2 - Endocardial Catheter Ablation
Standard Endocardial Catheter Ablation
ACTIVE COMPARATORStandard endocardial catheter ablation
Interventions
Minimally-invasive epicardial ablation +/- left atrial appendage exclusion using an epicardial clip, combined with endocardial radiofrequency catheter ablation
Standard percutaneous endocardial catheter ablation of atrial fibrillation
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Persistent or Long-standing Persistent AF
- Dilated left atrium (at least moderately dilated)
- Suitable for either procedure
- LVEF \< 50%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Ashford & St Peters Hospital NHS Trust
Chertsey, United Kingdom
Epsom General Hospital
Epsom, United Kingdom
Cromwell Hospital
London, United Kingdom
Royal Surrey County Hospital
London, United Kingdom
St Anthonys Hospital
London, United Kingdom
St Georges at Kingston Hospital
London, United Kingdom
St Georges University of London
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Riyaz A Kaba
St Georges Hospital NHS Trust
- PRINCIPAL INVESTIGATOR
Omar Ahmed
St Georges Hospital NHS Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant in Cardiology and Cardiac Electropysiology
Study Record Dates
First Submitted
May 20, 2022
First Posted
June 9, 2022
Study Start
June 25, 2022
Primary Completion
May 1, 2026
Study Completion (Estimated)
October 1, 2027
Last Updated
November 28, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share