The Impact of "First-Line" Rhythm Therapy on AF Progression

• Status: Active, not recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The PROGRESSIVE-AF Trial is a national, multi-center randomized controlled trial comparing early ("first-line") catheter-based pulmonary vein isolation (PVI) using cryothermal energy to first-line anti-arrhythmic drug therapy. The aim of the trial is to evaluate if the initial treatment choice (ablation vs. pharmacotherapy) influences AF disease progression, as measured by continuous cardiac monitoring. The outcomes of interest are disease progression, quality of life, and healthcare utilisation. The targeted population consists of healthy patients with symptomatic paroxysmal AF without clinically significant heart diseases aged between 18 and 75 years. This study represents a new research project leveraging the existing EARLY-AF randomised clinical trial infrastructure to examine the novel endpoints of: 1) disease progression ("time to first episode of persistent AF"), 2) progressive AF burden ("% time in AF"), 3) Quality of Life, and 4) healthcare utilisation at 36 months of follow-up.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborators: Medtronic; Ottawa Heart Institute Research Corporation
• Treatments: Anti-Arrhythmia Agents

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