Status:
UNKNOWN
Substrate Ablation and Remodelling in Non-paroxysmal Atrial Fibrillation (AF)
Lead Sponsor:
Liverpool Heart and Chest Hospital NHS Foundation Trust
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigators hypothesise that modification of the Atrial Fibrillation (AF) substrate by radiofrequency ablation would improve single procedure success rates for Radio Frequency Ablation (RFA) for...
Eligibility Criteria
Inclusion
- Ongoing symptoms (European Heart Rhythm Association Class 2 or above) in spite of treatment with rate control medication
- Non-paroxysmal atrial fibrillation, as pre-classified as
- Persistent AF: AF requiring Electrical/ Chemical cardioversion or that lasting \>7 days. These patients may be in AF or in sinus Rhythm at the time of their initial assessment and/ or at the time of their ablation.
- Continuous Persistent AF: These patients are persistently in AF with or without antiarrhythmic drug therapy, as confirmed on a 24 hour Holter. They may have undergone previous cardioversion(s).
- Sustained Paroxysmal AF with underlying substrate: Patients with Individual AF episode(s) lasting \>12 hours but less than 7 days plus one or more of the following:
- Age \>65 years 21
- Individual AF episode(s) lasting \>24 hours
- Significant left atrial dilatation of \>45 mm on Echo (Parasternal Long Axis view)
- Obesity (Body Mass Index \>30), and/ or history suggestive of sleep apnoea
- Diabetes Mellitus requiring hypoglycaemic drugs and/or Insulin
Exclusion
- Inability or unwillingness to receive oral anticoagulation with warfarin
- Previous Ablation procedure for AF
- Unwillingness or inability to complete the required follow up arrangements
- Presence of long standing persistent AF with continuous AF longer than 12 months. This includes patients in whom sinus rhythm may have been maintained following electrical cardioversion for a period of less than 1 week at a stretch.
- Documented typical atrial flutter
- Prior prosthetic mitral valve replacement or severe structural cardiac abnormality
- Contraindications and/ or prior intolerance to both Amiodarone and Flecainide.
- Reversible cause for atrial fibrillation
- Known hypertrophic or infiltrative cardiomyopathy
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2014
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01445925
Start Date
September 1 2011
End Date
November 1 2014
Last Update
August 22 2013
Active Locations (2)
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1
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom, L14 3PE
2
Royal Brompton and Harefield Hospitals NHS Trust
London, United Kingdom