Status:

RECRUITING

Hybrid Ablation of Atrial Fibrillation in Heart Failure

Lead Sponsor:

St. George's Hospital, London

Conditions:

Persistent Atrial Fibrillation

Atrial Fibrillation, Persistent

Eligibility:

All Genders

18+ years

Phase:

NA

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

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 fai...

Eligibility Criteria

Inclusion

  • Age ≥ 18 years
  • Persistent or Long-standing Persistent AF
  • Dilated left atrium (at least moderately dilated)
  • Suitable for either procedure
  • LVEF \< 50%

Exclusion

  • 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

Key Trial Info

Start Date :

June 25 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2027

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT05411614

Start Date

June 25 2022

End Date

October 1 2027

Last Update

November 28 2025

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Ashford & St Peters Hospital NHS Trust

Chertsey, United Kingdom

2

Epsom General Hospital

Epsom, United Kingdom

3

Cromwell Hospital

London, United Kingdom

4

Royal Surrey County Hospital

London, United Kingdom