Overview

This trial is active, not recruiting.

Condition atrial fibrillation
Treatments pulmonary vein isolation (pvi), pulmonary vein isolation + linear lesions, pharmacological substrate modification
Sponsor Liverpool Heart and Chest Hospital NHS Foundation Trust
Start date September 2011
End date November 2014
Trial size 130 participants
Trial identifier NCT01445925, LHCH901

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Patients will undergo pulmonary venous isolation plus pharmacological substrate modification
pulmonary vein isolation (pvi)
Using a 4mm irrigated tip radiofrequency ablation catheter a series of lesions >2 mm outside pulmonary vein (PV) ostia will be made to encircle and electrically isolate the pulmonary veins in two ipsilateral pairs (wide area circumferential ablation, WACA). A 20-pole PV mapping catheter will be used to confirm electrical isolation. If the patient is in atrial fibrillation at this stage, sinus rhythm would be restored with electrical cardioversion and PVI would be confirmed in sinus rhythm
pharmacological substrate modification
at least 6 weeks therapy with oral amiodarone prior to the ablation procedure and 6 weeks post.
(Experimental)
Patients will undergo pulmonary venous isolation plus both pharmacological and interventional substrate modification
pulmonary vein isolation + linear lesions
Using a 4mm irrigated tip radiofrequency ablation catheter a series of lesions >2 mm outside PV ostia will be made to encircle and electrically isolate the pulmonary veins in two ipsilateral pairs (wide area circumferential ablation, WACA)34. A 20-pole PV mapping catheter will be used to confirm electrical isolation. Once PVI has been achieved, patients will go onto to receive additional linear ablation lesions. These will include a left atrial roof line, mitral isthmus line, (including ablation inside the coronary sinus if necessary), and ablation on the cavotricuspid isthmus. If the patient is in atrial fibrillation at this stage, the acute end-point would be signal obliteration at the ablated area. Once sinus rhythm is restored with electrical cardioversion, PVI would be confirmed in sinus rhythm and conduction block across the LA roof line, Mitral line and CTI will then be verified with appropriate pacing manoeuvres.
pharmacological substrate modification
at least 6 weeks therapy with oral amiodarone prior to the ablation procedure and 6 weeks post.

Primary Outcomes

Measure
Freedom from atrial fibrillation/ atrial tachycardia at 6 months following a single procedure.
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Substrate Modification With Ablation and Antiarrhythmic Drugs in Non-Paroxysmal Atrial Fibrillation
Principal investigator Dhiraj Gupta, MD DM MRCP
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Liverpool Heart and Chest Hospital NHS Foundation Trust.