Cryoballoon ablation for treating persistent atrial fibrillation

Using Cryoballoon Ablation as Initial Treatment for Patients With Persistent Atrial Fibrillation Comparing to Anti-arrhythmic Drugs

This study is testing whether a procedure called cryoballoon ablation works better than medication for treating people with persistent atrial fibrillation who haven't had treatment before.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 286 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Locations: 17 sites (Fuzhou, Fujian and 16 other locations)
• Trial ID: NCT04942834 on ClinicalTrials.gov

What this trial studies

This study assesses the effectiveness and safety of cryoballoon ablation compared to anti-arrhythmic drug therapy as the initial treatment for patients with persistent atrial fibrillation who have not previously received treatment. Participants will be randomized into two groups: one receiving anti-arrhythmic medications and the other undergoing pulmonary vein isolation using a cryoballoon catheter. The goal is to determine which approach provides better outcomes for managing this condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with symptomatic persistent atrial fibrillation and a structurally normal heart.

Not a fit: Patients with a history of treatment for atrial fibrillation using anti-arrhythmic drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective and safer option for patients with persistent atrial fibrillation.

How similar studies have performed: Other studies have shown promising results with cryoballoon ablation for atrial fibrillation, indicating that this approach is gaining acceptance in clinical practice.

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
* 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

Where this trial is running

Fuzhou, Fujian and 16 other locations

• Fujian Provincial Hospital — Fuzhou, Fujian, China (Recruiting)
• Dongguan People's Hospital — Dongguan, Guangdong, China (Recruiting)
• Sun Yat-sen Memorial Hospital — Guangzhou, Guangdong, China (Recruiting)
• The First Affiliated Hospital,Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• The Affiliated Hospital Of Guizhou Medical University — Guiyang, Guizhou, China (Recruiting)
• Nanjing Drum Tower hospital — Nanjing, Jiangsu, China (Recruiting)
• Zhongda Hospital Southeast University — Nanjing, Jiangsu, China (Recruiting)
• Affiliated Hospital Of Nantong University — Nantong, Jiangsu, China (Recruiting)
• Jiangsu Taizhou People's Hospital — Taizhou, Jiangsu, China (Recruiting)
• Xuzhou Central Hospital — Xuzhou, Jiangsu, China (Recruiting)
• Qilu Hospital Of Shandong University — Jinan, Shangdong, China (Recruiting)
• Ruijin Hospital — Shanghai, Shanghai, China (Recruiting)
• Shanghai Tenth People's Hospital — Shanghai, Shanghai, China (Recruiting)
• "West China School of Medicine /West China Hospital of Sichuan University " — Chengdu, Sichuan, China (Recruiting)
• Tianjin Chest Hospital — Tianjin, Tianjin, China (Recruiting)
• The Second Hospital Of Tianjin Medical University — Tianjin, Tianjin, China (Recruiting)
• The First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (Recruiting)

Study contacts

• Principal investigator: Li-qun Wu, MD,PhD — Ruijin Hospital
• Study coordinator: Li-qun Wu, MD,PhD

Conditions Atrial Fibrillation, Persistent; Arrhythmias, Cardiac; cryoablation; pulmonary vein isolation; atrial fibrillation; Anti-Arrhythmic Agents