Hybrid Ablation of Atrial Fibrillation in Heart Failure
Recruiting · NCT05411614 · Interventional (participants receive a specific treatment) · Lead sponsor: St. George's Hospital, London
View the official record on ClinicalTrials.gov →Interventions studied
AtriCure EPi-Sense-AF Guided Coagulation System +/- AtriclipEndocardial Catheter Ablation
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
14 locations listed.
- Ashford & St Peters Hospital NHS Trust - Chertsey, United Kingdom
- Ashford & St Peters Hospital NHS Trust - Chertsey, United Kingdom
- Epsom General Hospital - Epsom, United Kingdom
- Epsom General Hospital - Epsom, United Kingdom
- Cromwell Hospital - London, United Kingdom
- Royal Surrey County Hospital - London, United Kingdom
- St Anthonys Hospital - London, United Kingdom
- St Georges at Kingston Hospital - London, United Kingdom
- St Georges University of London - London, United Kingdom
- Cromwell Hospital - London, United Kingdom
- Royal Surrey County Hospital - London, United Kingdom
- St Anthonys Hospital - London, United Kingdom
- St Georges at Kingston Hospital - London, United Kingdom
- St Georges University of London - London, United Kingdom