Objective Randomised Blinded Investigation of Therapeutic Ablation Versus Cardioversion for Persistent Atrial Fibrillation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Persistent Atrial Fibrillation
- Sponsor
- Barts & The London NHS Trust
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Recurrence of Persistent AF (of AF Episode Lasting > 7 Days).
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
The main aim of the research is to investigate whether patients undergoing pulmonary vein isolation with cryoablation for atrial fibrillation (AF) will have lower rates of AF recurrence than those treated by DC cardioversion without an ablation procedure. The objectives of the Pilot Study are to validate the key study logistics with a view to optimising methods to be used in the main study.
Detailed Description
After adequate stroke prevention (e.g. anticoagulation) and rate control, the optimum strategy for patients who continue to be symptomatic with persistent AF has not been established. Cardioversion with antiarrhythmic medication is commonly used as a first-line rhythm control strategy despite very high recurrence rates of the index arrhythmia and high serious complications associated with this strategy. Further treatment options, such as catheter ablation or implantation of a pacemaker and ablation of the atrioventricular (AV) node, are considered once AF recurs. The benefits of first-line ablation in patients presenting with persistent AF has not been tested. We seek to perform a blinded, randomised trial comparing an electrical cardioversion-led strategy with a pulmonary-vein isolation strategy for the treatment of persistent atrial fibrillation. No blinded randomised controlled trial comparing early-ablation strategies to cardioversion-led strategies has been performed. The rationale for blinding where possible in clinical trials is well established. The recently published ORBITA trial performed a blinded, multicentre randomised trial of percutaneous coronary intervention (PCI) in stable angina compared to a placebo procedure. This trial demonstrated that the efficacy of invasive procedures can be assessed with a placebo procedure and that this type of trial remains necessary. Knowledge of treatment assignment influences physician behaviour, drug recommendations and encourages bias in outcome reporting. The treatment effect size and the effects of confounding factors will be exaggerated and thus limit the interpretation of the true patient experienced outcomes either strategy. In a comparison of surgical procedures, a sham-control arm represents the gold standard of blinding. A systematic review of placebo-controlled surgical trials found no evidence of harm to participants assigned to the placebo group. For a procedure whose primary purpose is to give sustained symptomatic relief, definitive quantification of the true placebo-controlled effect size of AF ablation is necessary. There is a need to clarify the relationship between patient reported symptoms and the arrhythmia itself. Patient reported symptoms may not always be related to the severity of the arrhythmia or quality of life. No bias-resistant blinded, randomised, trial has yet been performed seeking to measure the benefits of AF ablation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who meet the following inclusion criteria will be eligible for the study;
- •Ability to give informed consent
- •Age 18-80 years
- •Persistent AF (atrial fibrillation lasting \> 7days) of total continuous duration \<2 years as documented in medical notes.
- •Patients being considered for cardioversion.
Exclusion Criteria
- •Patients who meet the following exclusion criteria will be ineligible for study participation;
- •Creatinine clearance (eGFR) \< 30mls/min
- •Contraindication or unable to take anticoagulation
- •Known contraindication to or unable to tolerate amiodarone
- •Uncontrolled hypertension
- •Contraindication to catheter ablation
- •BMI \> 35
Outcomes
Primary Outcomes
Recurrence of Persistent AF (of AF Episode Lasting > 7 Days).
Time Frame: Within 12 months following the procedure
Data on epsiodes of Atrial Fibrillation (rate, duration) will be provided by the loop recorder, and downloaded via a home monitoring system
Secondary Outcomes
- Bleeding Events(Within 7 days of the procedure)
- Death(Within 12 months of study recruitment)
- Rates of Subject Hospital Re-admission(Within 12 months following the procedure)
- Procedural Complications(At the time of the procedure)
- Rates of Repeat Procedures(within 12 months following the procedure)
- Clinical Success of Procedure(Within 12 months following the procedure)
- Change in Quality of Life Measures (Using Short Form-12 Survey)(Between baseline and 12 months after procedure)
- Change in Quality of Life Measures (AF-PROMS)(between baseline and 12 months after procedure)