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NCT Number: NCT05411614

Hybrid Ablation of Atrial Fibrillation in 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

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Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Arrhythmia Atrial Fibrillation Atrial Fibrillation, Persistent Cardiovascular Diseases Heart Diseases Heart Failure Left Ventricular (LV) Systolic Dysfunction Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ashford & St Peters Hospital NHS Trust, Chertsey, United Kingdom

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Minimally-invasive epicardial ablation +/- left atrial appendage exclusion using an epicardial clip, combined with endocardial radiofrequency catheter ablation

Other names: Convergent Hybrid Epicardial Endocardial Ablation plus/minus left atrial appendage exclusion

Endocardial Catheter Ablation

Device

Standard percutaneous endocardial catheter ablation of atrial fibrillation

Other names: Percutaneous Catheter Ablation

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

    Time frame: 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 outcomes

  1. Safety Endpoint

    Time frame: 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

  2. 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

    Recurrence of any atrial arrhythmia > 30 seconds on or off class I / III medications, considering any repeat ablation procedures

  3. 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

    Recurrence of any atrial arrhythmia > 30 seconds on or off class I / III medications, considering any repeat ablation procedures

  4. 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

    Left ventricular ejection fraction as recorded on transthoracic echocardiography (TTE)

  5. To assess left atrial remodelling in response to either technique.

    Time frame: Pre-procedure and up to 12 and 24 months post-procedure

    Left atrial dimensions/function on Echocardiography

  6. 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

    Change in European Heart Rhythm Association (EHRA) AF Symptom score

  7. 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

    Change in New York Heart Association (NYHA) class

  8. 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

    Change in EuroQol Quality of life Score (EQ5D)

  9. 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

    Change in Atrial Fibrillation Effect on Quality of Life Score (AFEQT)

Study contacts

Contact information is provided by the study sponsor or research team.

Omar Ahmed

CONTACT

[email protected]

020 8725 4571

Riyaz A Kaba

CONTACT

[email protected]

020 8725 4571

Sponsors and collaborators

Lead sponsor

St. George's Hospital, London

Other

Registry information

Official study title

A Randomised Controlled Trial Comparing Convergent Hybrid Ablation to Catheter Ablation in Patients With Persistent Atrial Fibrillation and Heart Failure

Acronym: HALT AF

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jun 9, 2022
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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