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

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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Cryoballoon-based PVI Drug: Anti-Arrhythmic Drug Therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Aggressive Invasive Intervention for Atrial Fibrillation
Study Start Date : January 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Cryoballoon-based PVI
Sinus rhythm control via a pulmonary vein isolation (PVI) ("first-line") procedure utilizing the the Arctic Front Cryoballoon Procedure.
 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.
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Total arrhythmia burden [ Time Frame: 60 months ]
    Total arrhythmia burden (daily AF burden - hours/day; overall AF burden - % time in AF)

  3. 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).

  4. Economic Evaluation [ Time Frame: to end of follow up at 36 months for each patient ]
    Incremental cost effectiveness ratio (ICER) for ony QALY gain


Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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): NCT02825979


Locations
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Sponsors and Collaborators
Jason Andrade
Ottawa Heart Institute Research Corporation
Medtronic
Baylis Medical Company
Investigators
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Principal Investigator: Jason Andrade, M.D. University of British Columbia
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jason Andrade, MD, University of British Columbia
ClinicalTrials.gov Identifier: NCT02825979    
Other Study ID Numbers: H16-00617
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Sotalol
Flecainide
Dronedarone
Propafenone
Anti-Arrhythmia Agents
Adrenergic beta-Antagonists
 Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators