Using Cryoballoon Ablation as Initial Treatment for Persistent Atrial Fibrillation
- Conditions
- Atrial Fibrillation, PersistentArrhythmias, Cardiac
- Interventions
- Drug: Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and AmiodaroneDevice: cryoballoon ablation
- Registration Number
- NCT04942834
- Lead Sponsor
- Ruijin Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 286
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Drug treatment group Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone receive class I or class III AAD to restore or maintain sinus rhythm. cryoballoon ablation group cryoballoon ablation receive cryoballoon ablation to restore sinus rhythm.
- Primary Outcome Measures
Name Time Method 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.
Rate of serious adverse events 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 Outcome Measures
Name Time Method 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)
time to first time cardiovascular hospitalization (month) one year time to first time cardiovascular hospitalization after treatment (month)
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
Trial Locations
- Locations (17)
The Second Hospital Of Tianjin Medical University
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Ürümqi, Xinjiang, China
The Affiliated Hospital Of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
Sun Yat-sen Memorial Hospital
🇨🇳Guangzhou, Guangdong, China
Dongguan People's Hospital
🇨🇳Dongguan, Guangdong, China
Fujian Provincial Hospital
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital,Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Nanjing Drum Tower hospital
🇨🇳Nanjing, Jiangsu, China
Shanghai Tenth People's Hospital
🇨🇳Shanghai, Shanghai, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
Affiliated Hospital Of Nantong University
🇨🇳Nantong, Jiangsu, China
Jiangsu Taizhou People's Hospital
🇨🇳Taizhou, Jiangsu, China
Xuzhou Central Hospital
🇨🇳Xuzhou, Jiangsu, China
Ruijin Hospital
🇨🇳Shanghai, Shanghai, China
"West China School of Medicine /West China Hospital of Sichuan University "
🇨🇳Chengdu, Sichuan, China
Tianjin Chest Hospital
🇨🇳Tianjin, Tianjin, China
Qilu Hospital Of Shandong University
🇨🇳Jinan, Shangdong, China