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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 : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

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:

  1. 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.
  2. 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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 396 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. emergency department visits or hospitalizations [ Time Frame: from randomization to day 364 ]
    The need for emergency department visits or hospitalizations

  4. 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.

  5. Quality of Life [ Time Frame: from randomization to day 364 ]
    Quality of Life (EQ-5 and Canadian Cardiovascular Society-Severity of AF scales)

  6. Total procedure duration [ Time Frame: day of the ablation procedure ]
    total ablation procedure duration in minutes

  7. 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

  8. Health Economic Analysis [ Time Frame: from randomization to day 364 ]
    Health care related costs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years
  2. 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
  3. At least one episode of AF documented on 12-lead ECG, Holter monitor or Loop recorder.
  4. Subjects must be able to provide informed consent

Exclusion Criteria:

  1. Subjects with persistent or permanent AF
  2. History of previous catheter or surgical ablation for AF
  3. Presence of known intracardiac thrombus
  4. Subjects with contraindication to systemic oral anticoagulation therapy, including a history of Heparin Induced Thrombocytopenia
  5. Subjects with reversible causes of AF
  6. Subjects with significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation)
  7. Subjects with known adverse reaction to adenosine
  8. Subjects with congenital heart disease
  9. Subjects that are pregnant

Information from the National Library of Medicine

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


Contacts
Contact: Girish Nair, MD 613-696-7272 gnair@ottawaheart.ca
Contact: Karen MacDonald, BPE 613-696-7000 ext 17077 kmacdonald@ottawaheart.ca

Locations
Canada, Alberta
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. Not yet 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         
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Principal Investigator: Girish Nair, MD         
St. Michael"s Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Paul Angaran, MD         
Principal Investigator: Paul Angaran, MD         
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada
Contact: Sheldon Singh, MD         
Principal Investigator: Sheldon Singh, MD         
Canada, Quebec
McGill University Health Center Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Vidal Essebag, MD         
Principal Investigator: Martin L. Bernier, MD         
Institut universitaire de cardiologie et de pneumologie de Quebec Not yet recruiting
Quebec City, Quebec, Canada, G1V 4G5
Contact: Jean-Francois Sarrazin, MD         
Principal Investigator: Jean-Francois Sarrazin, MD         
Centre hospitalier universitaire de Sherbrooke (CHUS) Not yet recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Jean-Francois Roux, MD         
Principal Investigator: Jean-Francois Roux, MD         
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
Principal Investigator: Girish Nair, MD Ottawa Heart Institute Research Corporation

Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02150902     History of Changes
Other Study ID Numbers: IRIS 2771
201610PJT-376677 ( Other Grant/Funding Number: CIHR )
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018

Keywords provided by Ottawa Heart Institute Research Corporation:
Catheter ablation for atrial fibrillation
treatment for atrial fibrillation
comparison of catheter ablation techniques for atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes