Arrhythmias, Cardiac, Atrial Fibrillation, Persistent
Conditions
Keywords
cryoablation, pulmonary vein isolation, atrial fibrillation, Anti-Arrhythmic Agents
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.
Interventions
DRUGAntiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone
Class I or III antiarrhythmic drug, including sotalol
DEVICEcryoballoon ablation
Pulmonary vein isolation by cryoballoon ablation using Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters (23mm and 28mm)
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 * New York Heart Association (NYHA) Class II, III or IV congestive heart failure * Primary pulmonary hypertension * Rheumatic heart disease * Thrombocytosis, thrombocytopenia * Any condition contraindicating chronic anticoagulation * Active systemic infection * Hypertrophic cardiomyopathy * Cryoglobulinemia * Uncontrolled hyperthyroidism * Any cerebral ischemic event (strokes or transient ischemic attacks (TIAs)) which occurred during the 6 month interval preceding the consent date * Any woman known to be pregnant or breastfeeding. * Life expectancy less than one year * Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic * Active intracardiac thrombus * Known drug or alcohol dependency * Unwilling or unable to comply fully with study procedures and follow-up * Significant Chronic Kidney Disease-estimated Glomerular Filtration Rate(CKD-eGFR) \<30umol/L
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment success at 12 months | 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（Dynamic ECG requires a minimum of 30 seconds, while a 12-lead ECG requires at least 10 seconds.）. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life changes at 12 months measured by AFEQT | one year | The improvement in quality of life between baseline and 12 months after the index ablation procedure or AAD measured by AF Quality of Life Survey (AFEQT) |
| Quality of life changes at 12 months measured by SF-12 | one year | The improvement in quality of life between baseline and 12 months after the index ablation procedure or AAD measured by 12-Item Short Form Survey (SF-12) |
| Arrhythmia recurrence during blanking period | 3 months | atrial tachycardia recurrence rate during the blanking period |
| time to first time cardiovascular hospitalization (month) | one year | time to first time cardiovascular hospitalization after treatment (month) |
| Rate of serious procedure-related and serious cryoablation system-related reported adverse events | one year | Rate of serious procedure-related and serious cryoablation system-related reported adverse events through 12 months after the index ablation procedure |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORLi-qun Wu, MD,PhD
Ruijin Hospital
Outcome results
None listed