Arrhythmias, Cardiac Clinical Trial
— Cryo-InitialAFOfficial title:
Using Cryoballoon Ablation as Initial Treatment for Patients With Persistent Atrial Fibrillation Comparing to Anti-arrhythmic Drugs
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.
Status | Recruiting |
Enrollment | 286 |
Est. completion date | January 2026 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | "West China School of Medicine /West China Hospital of Sichuan University " | Chengdu | Sichuan |
China | Dongguan People's Hospital | Dongguan | Guangdong |
China | Fujian Provincial Hospital | Fuzhou | Fujian |
China | Sun Yat-sen Memorial Hospital | Guangzhou | Guangdong |
China | The First Affiliated Hospital,Sun Yat-sen University | Guangzhou | Guangdong |
China | The Affiliated Hospital Of Guizhou Medical University | Guiyang | Guizhou |
China | Qilu Hospital Of Shandong University | Jinan | Shangdong |
China | Nanjing Drum Tower hospital | Nanjing | Jiangsu |
China | Zhongda Hospital Southeast University | Nanjing | Jiangsu |
China | Affiliated Hospital Of Nantong University | Nantong | Jiangsu |
China | Ruijin Hospital | Shanghai | Shanghai |
China | Shanghai Tenth People's Hospital | Shanghai | Shanghai |
China | Jiangsu Taizhou People's Hospital | Taizhou | Jiangsu |
China | The Second Hospital Of Tianjin Medical University | Tianjin | Tianjin |
China | Tianjin Chest Hospital | Tianjin | Tianjin |
China | The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang |
China | Xuzhou Central Hospital | Xuzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Ruijin Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment success at 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. | Randomization to 12 months | |
Primary | Rate of serious adverse events | Rate of serious procedure-related and serious cryoablation system-related reported adverse events through 12 months after the index ablation procedure | Randomization to 12 months | |
Secondary | Quality of life changes at 12 months measured by AFEQT | 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) | one year | |
Secondary | Quality of life changes at 12 months measured by SF-12 | 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) | one year | |
Secondary | Arrhythmia recurrence during blanking period | atrial tachycardia recurrence rate during the blanking period | 3 months | |
Secondary | time to first time cardiovascular hospitalization (month) | time to first time cardiovascular hospitalization after treatment (month) | one year |
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