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
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Procedure: Cryoballoon-based PVI Drug: Anti-Arrhythmic Drug Therapy||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||303 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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
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
|Principal Investigator:||Jason Andrade, M.D.||University of British Columbia|