Clincosm LogoSign in Get a demo

HALT-AF: Hybrid AbLaTion of Atrial Fibrillation

Sponsor
St. George's Hospital, London (Other)
Overall Status
Recruiting
CT.gov ID
NCT05411614
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
65
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Device: AtriCure EPi-Sense-AF Guided Coagulation System +/- Atriclip
  • Device: Endocardial Catheter Ablation
 N/A

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.

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Clinical study. 1:1 randomised. Convergent Hybrid Ablation Procedure versus standalone endocardial catheter ablation).Clinical study. 1:1 randomised. Convergent Hybrid Ablation Procedure versus standalone endocardial catheter ablation).
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomised Controlled Trial Comparing Hybrid Convergent Ablation to Standard Catheter Ablation in Patients With Non-Paroxysmal Atrial Fibrillation
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
Oct 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Convergent Hybrid Ablation with Left Atrial Appendage Exclusion

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

Device: AtriCure EPi-Sense-AF Guided Coagulation System +/- Atriclip
Minimally-invasive epicardial ablation with left atrial appendage exclusion using an epicardial clip, combined with endocardial radiofrequency catheter ablation
Other Names:
  • Convergent Hybrid Epicardial Endocardial Ablation Procedure with concomitant left atrial appendage exclusion

    • Device: Endocardial Catheter Ablation
    Standard percutaneous endocardial catheter ablation of atrial fibrillation
    Other Names:
  • Percutaneous Catheter Ablation

    		•
    Active Comparator: Standard Endocardial Catheter Ablation

    Standard endocardial catheter ablation

    Device: Endocardial Catheter Ablation
    Standard percutaneous endocardial catheter ablation of atrial fibrillation
    Other Names:
  • Percutaneous Catheter Ablation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Freedom from persistent atrial arrhythmia after a single procedure (either the completed hybrid ablation or catheter ablation) off Class I or III medications [Measured from the end of a 3-month blanking period up to 24 months]

      Recurrence of persistent atrial arrhythmia during follow-up months).

    Secondary Outcome Measures

    1. Safety Endpoint [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 [Measured from the end of a 3- month blanking period up to 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) [Measured from the end of a 3- month blanking period up to 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 [Pre-procedure and up to 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. [Pre-procedure and up to 24 months post-procedure]

      Left atrial size on Echocardiography

    6. To evaluate the effects of the interventions on the patient's symptoms and quality of life. [Pre-procedure and up to 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. [Pre-procedure and up to 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. [Pre-procedure and up to 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. [Pre-procedure and up to 24 months post-procedure]

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

    10. To evaluate Quality Adjusted Life Years (QALYs) accrued during the trial period. [12- and 24-months post-intervention]

      Analysis from Quality of Life scores

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St Georges University of London London United Kingdom

    Sponsors and Collaborators

    • St. George's Hospital, London

    Investigators

    • Principal Investigator: Riyaz A Kaba, St Georges Hospital NHS Trust
    • Principal Investigator: Omar Ahmed, St Georges Hospital NHS Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Riyaz Kaba, Consultant in Cardiology and Cardiac Electropysiology, St. George's Hospital, London
    ClinicalTrials.gov Identifier:
    NCT05411614
    Other Study ID Numbers:
    • 2021.0137
    First Posted:
    Jun 9, 2022
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of Jun 9, 2022