Persistent Atrial FibrillationHALT AFNCT05411614
Hybrid Ablation of Atrial Fibrillation in Heart Failure
A study testing AtriCure EPi-Sense-AF Guided Coagulation System +/- Atriclip and Endocardial Catheter Ablation in people with Persistent Atrial Fibrillation and Atrial Fibrillation, Persistent, run by St. George's Hospital, London at 7 sites in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation, Atrial Fibrillation, Persistent, Atrial Arrhythmia
- What is being tested?
- AtriCure EPi-Sense-AF Guided Coagulation System +/- Atriclip and Endocardial Catheter Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 25 Jun 2022to Oct 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Persistent or Long-standing Persistent AF
- Dilated left atrium (at least moderately dilated)
- Suitable for either procedure
- LVEF < 50%
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United Kingdom7 sites, 5 recruiting
- Recruiting
Ashford & St Peters Hospital NHS Trust
Chertsey
O Ahmed, 01932723988, omarahmed@nhs.net
- Recruiting
Epsom General Hospital
Epsom
Y Daryani, 01372 735735, yousef.darini@nhs.net
- Active, not recruiting
Cromwell Hospital
London
- Recruiting
Royal Surrey County Hospital
London
Zia Zuberi, +441483571122, rsch.cardiologyqueries@nhs.net
- Active, not recruiting
St Anthonys Hospital
London
- Recruiting
St Georges at Kingston Hospital
London
Magdi Saba, 020 8546 7711, m2109536@sgul.ac.uk
- Recruiting
St Georges University of London
London
Rosie Jacobs, researchgovernance@sgul.ac.uk
About this study
Official title: A Randomised Controlled Trial Comparing Convergent Hybrid Ablation to Catheter Ablation in Patients With Persistent Atrial Fibrillation and Heart Failure
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
Read the 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).
- Conditions
- Persistent Atrial Fibrillation, Atrial Fibrillation, Persistent, Atrial Arrhythmia, Atrial Fibrillation, Heart Failure, Left Ventricular (LV) Systolic Dysfunction
- Being tested
- AtriCure EPi-Sense-AF Guided Coagulation System +/- Atriclip, Endocardial Catheter Ablation
- Medical subject headings
- Atrial Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtriCure EPi-Sense-AF Guided Coagulation System +/- AtriclipDevice
Also called Convergent Hybrid Epicardial Endocardial Ablation plus/minus left atrial appendage exclusion
Minimally-invasive epicardial ablation +/- left atrial appendage exclusion using an epicardial clip, combined with endocardial radiofrequency catheter ablation
Endocardial Catheter AblationDevice
Also called Percutaneous Catheter Ablation
Standard percutaneous endocardial catheter ablation of atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| Convergent Hybrid Ablation +/- Left Atrial Appendage Exclusion | Experimental | Staged Convergent Hybrid Ablation Procedure
Stage 1 - Minimally-Invasive Surgical Epicardial Ablation Procedure +/- concomitant LAA exclusion.
Stage 2 - Endocardial Catheter Ablation Receives: Device: AtriCure EPi-Sense-AF Guided Coagulation System +/- Atriclip; Device: Endocardial Catheter Ablation |
| Standard Endocardial Catheter Ablation | Active comparator | Standard endocardial catheter ablation Receives: Device: Endocardial Catheter Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured from the end of a 3-month blanking period at 12 and 24 months
Secondary outcomes (9)
Safety Endpoint
Safety endpoint of severe and non-severe complications as defined in the protocol
Measured: 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
Recurrence of any atrial arrhythmia > 30 seconds on or off class I / III medications, considering any repeat ablation procedures
Measured: 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)
Recurrence of any atrial arrhythmia > 30 seconds on or off class I / III medications, considering any repeat ablation procedures
Measured: 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
Left ventricular ejection fraction as recorded on transthoracic echocardiography (TTE)
Measured: Pre-procedure and at 12 and 24 months post-procedure
To assess left atrial remodelling in response to either technique.
Left atrial dimensions/function on Echocardiography
Measured: 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)
Change in European Heart Rhythm Association (EHRA) AF Symptom score
Measured: 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).
Change in New York Heart Association (NYHA) class
Measured: 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)
Change in EuroQol Quality of life Score (EQ5D)
Measured: 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)
Change in Atrial Fibrillation Effect on Quality of Life Score (AFEQT)
Measured: Pre-procedure and at 12 and 24 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start25 Jun 2022
- Primary completionMay 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical study. 1:1 randomised. Convergent Hybrid Ablation Procedure versus standalone endocardial catheter ablation).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. George's Hospital, London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riyaz Kaba, St. George's Hospital, London
- Investigators
- Riyaz A Kaba, Principal investigator, St Georges Hospital NHS TrustOmar Ahmed, Principal investigator, St Georges Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411614
- Sponsor's protocol ID
- 2021.0137
- Acronym
- HALT AF
- Status last verified
- Nov 2025
- First submitted
- 20 May 2022
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 42216292