Augmented Wide Area Circumferential Catheter Ablation for Reduction of Atrial Fibrillation Recurrence (AWARE)
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|ClinicalTrials.gov Identifier: NCT02150902|
Recruitment Status : Recruiting
First Posted : May 30, 2014
Last Update Posted : September 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Procedure: Wide area circumferential catheter ablation Procedure: Augmented- wide area circumferential ablation procedure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||396 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||AUGMENTED WIDE AREA CIRCUMFERENTIAL CATHETER ABLATION FOR REDUCTION OF ATRIAL FIBRILLATION RECURRENCE - A RANDOMIZED CLINICAL TRIAL (The AWARE Trial)|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Augmented- WACA
Augmented- wide area circumferential catheter ablation for atrial fibrillation
Procedure: Augmented- wide area circumferential ablation procedure
Subjects in this group will have WACA performed as described for WACA. Following completion of the WACA procedure a second set of circumferential ablation lesions will be delivered around the first set of ablation lesions. The ablation catheter tip will be positioned at each of the ablation lesions along the first WACA line and then moved away (from the PV ostia) until healthy, non ablated tissue is recorded from the catheter tip. Energy will be delivered using CF and FTI data as described previously. Once the first WACA ablation line has been completely duplicated the procedure will be deemed complete. In case PV isolation is not achieved after the first WACA lesion set repeat electrophysiologic testing will be performed to determine whether the augmented-WACA procedure was successful in achieving PV isolation.
Other Name: Augmented WACA
Active Comparator: WACA
Wide area circumferential catheter ablation procedure for atrial fibrillation
Procedure: Wide area circumferential catheter ablation
All subjects in the control arm of the trial will undergo wide area circumferential catheter ablation (WACA; lesions delivered 1-2 cm away from the pulmonary vein ostium) around all four pulmonary veins to the endpoint of electrical isolation (demonstrated by entry and exit block using differential pacing). Catheter ablation will be performed using contact force (CF) and electroanatomical mapping system guidance (average CF >10g, FTI > 500 g-sec and minimum ablation duration >10 sec). Dormant pulmonary vein conduction will be tested using adenosine, after completion of the lesion set, and additional lesions will be delivered to eliminate dormant PV conduction.
Other Name: WACA
- 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.
- repeat catheter ablation procedure [ Time Frame: days 91 and 364 after catheter ablation ]The need for repeat catheter ablation procedure because of documented recurrence of symptomatic AF, AFl or AT
- ECG documented AF [ Time Frame: during the first 90 days after catheter ablation ]Incidence of any ECG documented AF (symptomatic or asymptomatic) during the first 90 days after catheter ablation
- emergency department visits or hospitalizations [ Time Frame: from randomization to day 364 ]The need for emergency department visits or hospitalizations
- procedure related complications [ Time Frame: from ablation to day 364 ]Composite safety endpoints- procedure related complications (Stroke, PV stenosis, Pericarditis, Cardiac perforation, Atrio-esophageal fistula, Major bleeding) and/or death.
- Quality of Life [ Time Frame: from randomization to day 364 ]Quality of Life (EQ-5 and Canadian Cardiovascular Society-Severity of AF scales)
- Total procedure duration [ Time Frame: day of the ablation procedure ]total ablation procedure duration in minutes
- Total radiation exposure during the procedure [ Time Frame: day of the ablation procedure ]Dose area product in McGy.cm2 and cumulative skin dose in mGv
- Health Economic Analysis [ Time Frame: from randomization to day 364 ]Health care related costs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02150902
|Contact: Girish Nair, MDfirstname.lastname@example.org|
|Contact: Karen MacDonald, BPE||613-696-7000 ext email@example.com|
|University of Calgary-Foothills Campus||Recruiting|
|Calgary, Alberta, Canada, T2N 4Z6|
|Contact: George Veenhuyzen, MD|
|Principal Investigator: George Veenhuyzen, MD|
|Canada, British Columbia|
|Victoria Cardiac Arrhythmia Trials Inc.||Recruiting|
|Victoria, British Columbia, Canada, V8T 1Z4|
|Contact: Laurence Sterns, MD|
|Principal Investigator: Laurence Sterns, MD|
|Canada, Nova Scotia|
|QE II Health Sciences Centre||Recruiting|
|Halifax, Nova Scotia, Canada, B3H 3A7|
|Contact: Ratika Parkash, MD|
|Principal Investigator: Ratika Parkash, MD|
|University of Ottawa Heart Institute||Recruiting|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Principal Investigator: Girish Nair, MD|
|St. Michael"s Hospital||Recruiting|
|Toronto, Ontario, Canada, M5B 1W8|
|Contact: Paul Angaran, MD|
|Principal Investigator: Paul Angaran, MD|
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada|
|Contact: Sheldon Singh, MD|
|Principal Investigator: Sheldon Singh, MD|
|McGill University Health Center||Recruiting|
|Montreal, Quebec, Canada, H3G 1A4|
|Contact: Vidal Essebag, MD|
|Principal Investigator: Martin L. Bernier, MD|
|CIUSSSNIM-Hopital du Sacre-Coeur de Montreal||Recruiting|
|Montreal, Quebec, Canada, H4J 1C5|
|Contact: Giuliano Becker, MD firstname.lastname@example.org|
|Principal Investigator: Giuliano Becker, MD|
|Institut universitaire de cardiologie et de pneumologie de Quebec||Recruiting|
|Quebec City, Quebec, Canada, G1V 4G5|
|Contact: Jean-Francois Sarrazin, MD|
|Principal Investigator: Jean-Francois Sarrazin, MD|
|Centre hospitalier universitaire de Sherbrooke (CHUS)||Recruiting|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Contact: Charles Dussault, MD|
|Principal Investigator: Charles Dussault, MD|
|Principal Investigator:||Girish Nair, MD||Ottawa Heart Institute Research Corporation|