Using Cryoballoon Ablation as Initial Treatment for Persistent Atrial Fibrillation
NCT ID: NCT04942834
Last Updated: 2024-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
286 participants
INTERVENTIONAL
2021-10-01
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Drug treatment group
receive class I or class III AAD to restore or maintain sinus rhythm.
Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone
Class I or III antiarrhythmic drug, including sotalol
cryoballoon ablation group
receive cryoballoon ablation to restore sinus rhythm.
cryoballoon ablation
Pulmonary vein isolation by cryoballoon ablation using Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters (23mm and 28mm)
Interventions
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Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone
Class I or III antiarrhythmic drug, including sotalol
cryoballoon ablation
Pulmonary vein isolation by cryoballoon ablation using Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters (23mm and 28mm)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Principal Investigators
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Li-qun Wu, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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Fujian Provincial Hospital
Fuzhou, Fujian, China
Dongguan People's Hospital
Dongguan, Guangdong, 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
Nanjing Drum Tower hospital
Nanjing, Jiangsu, 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
Qilu Hospital Of Shandong University
Jinan, Shangdong, China
Ruijin Hospital
Shanghai, Shanghai Municipality, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
"West China School of Medicine /West China Hospital of Sichuan University "
Chengdu, Sichuan, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
The Second Hospital Of Tianjin Medical University
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Cryo-initial-AF
Identifier Type: -
Identifier Source: org_study_id
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