AUGMENTED WIDE AREA CIRCUMFERENTIAL CATHETER ABLATION FOR REDUCTION OF ATRIAL FIBRILLATION RECURRENCE - A RANDOMIZED CLINICAL TRIAL (The AWARE Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 411
- Locations
- 21
- Primary Endpoint
- Time to First Recurrence of any ECG documented AF, AFl or AT
Study Overview
Brief Summary
Atrial fibrillation (AF) is an abnormal heart rhythm in which the top chambers of the heart beat very fast. AF catheter ablation is a known technique to convert heart rhythm from AF to normal rhythm. The technique sends out electrical energy through a catheter (long thin round solid tubes) to destroy the heart tissues in a focused area where AF is starting. This technique is practiced at many hospitals, including the Heart Institute, and is not experimental.
The AWARE study will compare two techniques of AF catheter ablation:
- Ablation of tissues in wide circular bands around the opening of the pulmonary veins (bring blood back from lungs) in the left upper chamber of the heart. A medicine called adenosine will be given to unmask any incompletely ablated area. Additional ablations will be given if required. This is standard procedure.
- Same as above but adenosine will not be used. Instead, additional ablation of a second circular band of tissues around the opening of the pulmonary veins will be given. This additional ablation is not standard procedure and is considered experimental.
The Investigators are testing if adding more ablation sites will help maintain normal heart rhythm and reduce the rate of return to AF. The study will compare the occurrence of medical events and complications between the two groups.
Identical supplies and equipment used in both techniques have been approved by Health Canada. Adenosine is currently approved by Health Canada for the treatment and diagnosis of arrhythmias.
396 participants from study sites across Canada will be randomly assigned "similar to flipping a coin" to treatment group 1 or group 2.
After the ablation, participants will have study follow-up at 3, 6 and 12 months. All participant's will be followed for a minimum of 12 months.
Detailed Description
Clinical relevance:
The problem of PV reconnection and recurrent AF after catheter ablation for paroxysmal AF is one of the important challenges faced by treating physicians.
Rationale:
The understanding of the role contact force plays in adequate lesion formation during catheter ablation and the fact that this may reduce pulmonary vein (PV) reconnection and AF recurrence is an exciting advance in the field of catheter ablation for AF. A few small clinical trials have demonstrated the safety and feasibility of contact force guided catheter ablation in reducing PV reconnection and AF recurrence. There is a clear need for well designed and adequately powered clinical trials to evaluate the effectiveness of this new strategy. The investigators have developed a novel "augmented" CF guided augmented ablation strategy and will test this against the current clinical gold standard ablation technique.
Objective:
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
- •Age ≥18 years
- •Subjects must have symptomatic Paroxysmal AF that is refractory to at least one class I or Class III antiarrhythmic medication OR be intolerant of antiarrhythmic medications OR prefer not to trial antiarrhythmic medications
- •At least one episode of AF documented on 12-lead ECG, Holter monitor or Loop recorder.
- •Subjects must be able to provide informed consent
Exclusion Criteria
- •Subjects with persistent or permanent AF
- •History of previous catheter or surgical ablation for AF
- •Presence of known intracardiac thrombus
- •Subjects with contraindication to systemic oral anticoagulation therapy, including a history of Heparin Induced Thrombocytopenia
- •Subjects with reversible causes of AF
- •Subjects with significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation)
- •Subjects with known adverse reaction to adenosine
- •Subjects with congenital heart disease
- •Subjects that are pregnant
Arms & Interventions
Augmented- WACA
Augmented- wide area circumferential catheter ablation for atrial fibrillation
Intervention: Augmented- wide area circumferential ablation procedure (Procedure)
WACA
Wide area circumferential catheter ablation procedure for atrial fibrillation
Intervention: Wide area circumferential catheter ablation (Procedure)
Outcomes
Primary Outcomes
Time to First Recurrence of any ECG documented AF, AFl or AT
Time Frame: between days 91 and 364 after catheter ablation
Time to first recurrence of any ECG documented AF, AFl or AT (symptomatic or asymptomatic) occurring between days 91 and 364 after catheter ablation in the absence of Class I or III antiarrhythmic drug therapy.
Secondary Outcomes
- Quality of Life measurement using (EQ-5 and Canadian Cardiovascular Society-Severity of AF scales)(from randomization to day 364)
- Total radiation exposure during the procedure(day of the ablation procedure)
- emergency department visits or hospitalizations(from randomization to day 364)
- procedure related complications(from ablation to day 364)
- Total procedure duration(day of the ablation procedure)
- The need for repeat catheter ablation procedure(days 91 and 364 after catheter ablation)
- ECG documented AF(during the first 90 days after catheter ablation)
- Health Economic Analysis(from randomization to day 364)