Using Cryoballoon Ablation as Initial Treatment for Patients With Persistent Atrial Fibrillation Comparing to Anti-arrhythmic Drugs
Overview
- Phase
- Not Applicable
- Intervention
- Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone
- Conditions
- Atrial Fibrillation, Persistent
- Sponsor
- Ruijin Hospital
- Enrollment
- 286
- Locations
- 17
- Primary Endpoint
- Treatment success at 12 months
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This study is to assess the effectiveness and safety of using cryoballoon ablation comparing with anti-arrhythmic drug therapy as initial treatment for naive patients with persistent atrial fibrillation.
Detailed Description
Subjects with persistent atrial fibrillation with no history of treatment with anti-arrhythmic drugs are randomized 1:1 to either an anti-arrhythmic drug or pulmonary vein isolation using the cryoballoon catheter.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Documentation of symptomatic persistent AF: Defined as having a continuous episode lasting longer than 7 days but less than 1 year documented by consecutive ECG recordings OR Defined as having a continuous episode lasting longer than 7 days but less than 1 year documented by an ECG recording and one doctor note indicating patient had symptoms consistent with AF
- •Age 18 -75 years old
- •Structurally normal heart with LVEF ≥50%, interventricular septum thickness ≤ 12 mm, and left atrial diameter \<46 mm (short axis) as obtained by transthoracic echocardiography. •
- •Normal ECG parameters when measured in sinus rhythm (QRS width ≤120 ms in a 12-channel surface ECG, QTc interval \<440 ms, and PQ interval ≤210 ms).
Exclusion Criteria
- •History of AF treatment with class I or III antiarrhythmic drug, including sotalol, with the intention to prevent an AF recurrence. However, patients pretreated with above AAD for less than 7 days with the intention to convert an AF episode are allowed.
- •left atrial ablation or surgical procedure (including left atrial appendage closures)
- •Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months
- •Presence of any pulmonary vein stents
- •Presence of any pre-existing pulmonary vein stenosis
- •Pre-existing hemidiaphragmatic paralysis
- •Presence of any cardiac valve prosthesis
- •+3 and +4 mitral valve regurgitation or stenosis
- •Any cardiac surgery, myocardial infarction, percutaneous coronary intervention (PCI) / percutaneous transluminal coronary angioplasty (PTCA) or coronary artery stenting which occurred during the 3 month interval preceding e consent date
- •Unstable angina
Arms & Interventions
Drug treatment group
receive class I or class III AAD to restore or maintain sinus rhythm.
Intervention: Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone
cryoballoon ablation group
receive cryoballoon ablation to restore sinus rhythm.
Intervention: cryoballoon ablation
Outcomes
Primary Outcomes
Treatment success at 12 months
Time Frame: Randomization to 12 months
Treatment success at 12 months after antiarrhythmic drug (AAD) initiation or ablation utilizing cryoballoon catheter measured by freedom from AF recurrence following a 3-month period after the index ablation or AAD initiation.
Rate of serious adverse events
Time Frame: Randomization to 12 months
Rate of serious procedure-related and serious cryoablation system-related reported adverse events through 12 months after the index ablation procedure
Secondary Outcomes
- Quality of life changes at 12 months measured by AFEQT(one year)
- time to first time cardiovascular hospitalization (month)(one year)
- Quality of life changes at 12 months measured by SF-12(one year)
- Arrhythmia recurrence during blanking period(3 months)