NCT05411614

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
recruiting

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

Study Progress73%
Jun 2022Oct 2027

First Submitted

Initial submission to the registry

May 20, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 9, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

June 25, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Expected
Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

3.9 years

First QC Date

May 20, 2022

Last Update Submit

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

EXPERIMENTAL

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

Device: AtriCure EPi-Sense-AF Guided Coagulation System +/- AtriclipDevice: Endocardial Catheter Ablation

Standard Endocardial Catheter Ablation

ACTIVE COMPARATOR

Standard endocardial catheter ablation

Device: Endocardial Catheter Ablation

Interventions

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

Also known as: Convergent Hybrid Epicardial Endocardial Ablation plus/minus left atrial appendage exclusion
Convergent Hybrid Ablation +/- Left Atrial Appendage Exclusion

Standard percutaneous endocardial catheter ablation of atrial fibrillation

Also known as: Percutaneous Catheter Ablation
Convergent Hybrid Ablation +/- Left Atrial Appendage ExclusionStandard Endocardial Catheter Ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

Epsom General Hospital

Epsom, United Kingdom

RECRUITING

Cromwell Hospital

London, United Kingdom

ACTIVE NOT RECRUITING

Royal Surrey County Hospital

London, United Kingdom

RECRUITING

St Anthonys Hospital

London, United Kingdom

ACTIVE NOT RECRUITING

St Georges at Kingston Hospital

London, United Kingdom

RECRUITING

St Georges University of London

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationHeart Failure

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Riyaz A Kaba

    St Georges Hospital NHS Trust

    PRINCIPAL INVESTIGATOR
  • Omar Ahmed

    St Georges Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Clinical study. 1:1 randomised. Convergent Hybrid Ablation Procedure versus standalone endocardial catheter ablation).
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

Locations