Skip to main content
Clinical Trials/NCT01445925
NCT01445925UnknownNot Applicable

Substrate Modification With Ablation and Antiarrhythmic Drugs in Non-Paroxysmal Atrial Fibrillation

Liverpool Heart and Chest Hospital NHS Foundation Trust2 sites in 1 country130 target enrollmentStarted: September 2011Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Enrollment
130
Locations
2
Primary Endpoint
Freedom from atrial fibrillation/ atrial tachycardia at 6 months following a single procedure.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Pulmonary vein isolation

Active Comparator

Patients will undergo pulmonary venous isolation plus pharmacological substrate modification

Intervention: Pulmonary vein isolation (PVI) (Procedure)

Pulmonary vein isolation

Active Comparator

Patients will undergo pulmonary venous isolation plus pharmacological substrate modification

Intervention: Pharmacological Substrate modification (Drug)

Pulmonary vein isolation + Linear Lesions

Experimental

Patients will undergo pulmonary venous isolation plus both pharmacological and interventional substrate modification

Intervention: Pulmonary vein isolation + linear lesions (Procedure)

Pulmonary vein isolation + Linear Lesions

Experimental

Patients will undergo pulmonary venous isolation plus both pharmacological and interventional substrate modification

Intervention: Pharmacological Substrate modification (Drug)

Outcomes

Primary Outcomes

Freedom from atrial fibrillation/ atrial tachycardia at 6 months following a single procedure.

Time Frame: 12 months

Defined as \>30 sec of AF/ atrial tachycardia identified on ECG or ambulatory ECG monitoring following a 3 month blanking period.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dhiraj Gupta

Consultant Cardiologist

Liverpool Heart and Chest Hospital NHS Foundation Trust

Study Sites (2)

Loading locations...

Similar Trials