Clinical trial NCT01445925: Substrate Ablation and Remodelling in Non-paroxysmal Atrial Fibrillation (AF)
Official title: Substrate Modification With Ablation and Antiarrhythmic Drugs in Non-Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2011-10-04
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Non-paroxysmal AF when compared to that achieved with short-term peri-procedural anti-arrhythmic drug therapy alone.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Freedom from atrial fibrillation/ atrial tachycardia at 6 months following a single procedure.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: London
country: United Kingdom
facility: Royal Brompton and Harefield Hospitals NHS Trust
Study officials:
affiliation: Liverpool Heart and Chest Hospital
name: Dhiraj Gupta, MD DM MRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wynn GJ, DAS M, Bonnett LJ, Hall MCS, Snowdon RL, Waktare JEP, Modi S, Todd DM, Gupta D. A novel marker to predict early recurrence after atrial fibrillation ablation: the ablation effectiveness quotient. J Cardiovasc Electrophysiol. 2015 Apr;26(4):397-403. doi: 10.1111/jce.12618. Epub 2015 Feb 25.