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Early Aggressive Invasive Intervention for Atrial Fibrillation (EARLY-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02825979
Recruitment Status : Active, not recruiting
First Posted : July 7, 2016
Last Update Posted : April 21, 2020
Sponsor:
Collaborators:
Ottawa Heart Institute Research Corporation
Medtronic
Baylis Medical Company
Information provided by (Responsible Party):
Jason Andrade, University of British Columbia

Tracking Information
First Submitted Date  ICMJE May 18, 2016
First Posted Date  ICMJE July 7, 2016
Last Update Posted Date April 21, 2020
Study Start Date  ICMJE January 2017
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2016)
Time to recurrence of symptomatic or asymptomatic Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia [ Time Frame: Time to first recurrence between days 91 and 365 post randomization. ]
The single procedure success (in the absence of AAD) is defined as the time to first recurrence of symptomatic** or asymptomatic AF, atrial flutter, or atrial tachycardia (AF/AFL/AT) documented by 12-lead ECG, surface ECG rhythm strips, ambulatory ECG monitor, or on implantable loop recorder and lasting 120 seconds or longer as adjudicated by a blinded group of investigators between days 91 and 365 post randomization.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2018)
  • Time to recurrence of symptomatic AF/AFL/AT [ Time Frame: Time to first recurrence between day 0 and 365 post Ablation ]
    Time to first recurrence of symptomatic documented AF/AFL/AT between days 91 and 365 after ablation or a repeat ablation procedure between days 0 and 365 post ablation.
  • Total arrhythmia burden [ Time Frame: 60 months ]
    Total arrhythmia burden (daily AF burden - hours/day; overall AF burden - % time in AF)
  • Major complications of ablation, or significant adverse drug events (death, ventricular pro-arrhythmia, syncope, hypotension requiring hospitalisation, pacemaker insertion). [ Time Frame: Acute peri-procedural complications will be defined as occurring within 30 days of ablation, with delayed complications occurring 31-365 days after ablation. ]
    Events include events death, ventricular pro-arrhythmia, syncope, hypotension requiring hospitalisation, pacemaker insertion).
  • Economic Evaluation [ Time Frame: to end of follow up at 36 months for each patient ]
    Incremental cost effectiveness ratio (ICER) for ony QALY gain
Original Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2016)
  • Time to recurrence of symptomatic AF/AFL/AT [ Time Frame: Time to first recurrence between day 0 and 365 post Ablation ]
    Time to first recurrence of symptomatic documented AF/AFL/AT between days 91 and 365 after ablation or a repeat ablation procedure between days 0 and 365 post ablation.
  • Total arrhythmia burden [ Time Frame: 60 months ]
    Total arrhythmia burden (daily AF burden - hours/day; overall AF burden - % time in AF)
  • Major complications of ablation, or significant adverse drug events (death, ventricular pro-arrhythmia, syncope, hypotension requiring hospitalisation, pacemaker insertion). [ Time Frame: Acute peri-procedural complications will be defined as occurring within 30 days of ablation, with delayed complications occurring 31-365 days after ablation. ]
    Events include events death, ventricular pro-arrhythmia, syncope, hypotension requiring hospitalisation, pacemaker insertion).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Aggressive Invasive Intervention for Atrial Fibrillation
Official Title  ICMJE Early Aggressive Invasive Intervention for Atrial Fibrillation
Brief Summary The EARLY-AF study is centered on an evaluation of the impact of the early invasive management of Atrial Fibrillation. The primary goal of the study is to evaluate the clinical effectiveness of an early invasive approach. Specifically, the investigators are aiming to evaluate if PVI performed with the Arctic Front cryoballoon is superior to AAD as first-line therapy in preventing atrial arrhythmia recurrences (arrhythmia related symptoms, hospitalisations, and health care utilization).
Detailed Description

The EARLY-AF study is centered on an evaluation of the impact of the early invasive management of Atrial Fibrillation.

All patients will undergo a loop recorder implantation (REVEAL LINQ, Medtronic), also called an insertable cardiac monitor (ICM), at the time of study enrolment using standard clinical implant procedures.

The primary goal of the study is to evaluate the clinical effectiveness of an early invasive approach. Specifically, the investigators are aiming to evaluate if PVI performed with the Arctic Front cryoballoon is superior to AAD as first-line therapy in preventing atrial arrhythmia recurrences (arrhythmia related symptoms, hospitalisations, and health care utilization).

The secondary goal of the program is to evaluate the health related quality of life (HRQOL) impact associated with early invasive intervention, in comparison to primary AAD therapy. This analysis will be centered on an evaluation of generic and disease-specific HRQOL instruments in order to determine the impact of an early invasive approach. A secondary benefit is the derivation of a Quality Adjusted Life Years (QALYs) score, which can be used as a summary measure of health outcome and to inform subsequent healthcare resource allocation decisions.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • Procedure: Cryoballoon-based PVI
    Patients randomized to first-line cryoballoon (CB) ablation will have the pulmonary vein isolation procedure performed according to standard clinical practice using the Arctic Front Cryoballoon ablation catheter. No anti-arrhythmic drugs will be prescribed in this arm.
  • Drug: Anti-Arrhythmic Drug Therapy
    Antiarrhythmic drug therapy (Class I - flecainide, propafenone; Class III - sotalol, dronedarone) will prescribed and monitored based on local clinical practice, and according to guideline-suggested drug management for symptomatic patients with paroxysmal AF.
    Other Name: sotalol, flecainide, propafenone, dronedarone
Study Arms  ICMJE
  • Active Comparator: Cryoballoon-based PVI
    Sinus rhythm control via a pulmonary vein isolation (PVI) ("first-line") procedure utilizing the the Arctic Front Cryoballoon Procedure.
    Intervention: Procedure: Cryoballoon-based PVI
  • Active Comparator: Anti-Arrhythmic Drug Therapy
    Sinus rhythm control via the use of anti-arrhythmic drug (AAD) therapy ("first-line") based on local clinical practice, and according to guideline-suggested drug management for symptomatic patients with paroxysmal AF.
    Intervention: Drug: Anti-Arrhythmic Drug Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 29, 2019)
303
Original Estimated Enrollment  ICMJE
 (submitted: July 6, 2016)
298
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Non-permanent AF documented on a 12 lead ECG, Trans Telephonic Monitoring (TTM) or Holter monitor within the last 24 months
  • Age of 18 years or older on the date of consent
  • Candidate for ablation based on AF that is symptomatic
  • Informed Consent

Exclusion Criteria:

  • Regular (daily) use of a class 1 or 3 antiarrhythmic drug (pill-in-the-pocket AAD use is permitted) at sufficient therapeutic doses according to guidelines (flecainide >50 mg BID, sotalol >80 mg BID, propafenone >150 mg BID
  • Previous left atrial (LA) ablation or LA surgery
  • AF due to reversible cause (e.g. hyperthyroidism, cardiothoracic surgery)
  • Active Intracardiac Thrombus
  • Pre-existing pulmonary vein stenosis or PV stent
  • Pre-existing hemidiaphragmatic paralysis
  • Contraindication to anticoagulation or radiocontrast materials
  • Left atrial anteroposterior diameter greater than 5.5 cm by transthoracic echocardiography
  • Cardiac valve prosthesis
  • Clinically significant (moderately-severe, or severe) mitral valve regurgitation or stenosis
  • Myocardial infarction, PCI / PTCA, or coronary artery stenting during the 3-month period preceding the consent date
  • Cardiac surgery during the three-month interval preceding the consent date
  • Significant congenital heart defect (including atrial septal defects or PV abnormalities but not including PFO)
  • NYHA class III or IV congestive heart failure
  • Left ventricular ejection fraction (LVEF) less than 35%
  • Hypertrophic cardiomyopathy (septal or posterior wall thickness >1.5 cm)
  • Significant Chronic Kidney Disease (CKD - eGFR <30 µMol/L)
  • Uncontrolled hyperthyroidism
  • Cerebral ischemic event (strokes or TIAs) during the six-month interval preceding the consent date
  • Pregnancy
  • Life expectancy less than one (1) year
  • Currently participating or anticipated to participate in any other clinical trial of a drug, device or biologic that has the potential to interfere with the results of this study
  • Unwilling or unable to comply fully with study procedures and follow-up
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02825979
Other Study ID Numbers  ICMJE H16-00617
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Jason Andrade, University of British Columbia
Study Sponsor  ICMJE Jason Andrade
Collaborators  ICMJE
  • Ottawa Heart Institute Research Corporation
  • Medtronic
  • Baylis Medical Company
Investigators  ICMJE
Principal Investigator: Jason Andrade, M.D. University of British Columbia
PRS Account University of British Columbia
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP