Using Cryoballoon Ablation as Initial Treatment for Persistent Atrial Fibrillation (Cryo-InitialAF)

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.

Study Overview

• Status: Completed
• Conditions: Arrhythmias, Cardiac; Atrial Fibrillation, Persistent
• Intervention / Treatment: Drug: Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone; Device: cryoballoon ablation

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.

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Provincial Hospital
  • Guangdong
    • Dongguan, Guangdong, China, 523018
      • Dongguan People's Hospital
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-sen Memorial Hospital
    • Guangzhou, Guangdong, China, 511466
      • The First Affiliated Hospital,Sun Yat-sen University
  • Guizhou
    • Guiyang, Guizhou, China, 561113
      • The Affiliated Hospital of Guizhou Medical University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University
    • Nantong, Jiangsu, China, 226019
      • Affiliated Hospital of Nantong University
    • Taizhou, Jiangsu, China, 225300
      • Jiangsu Taizhou People's Hospital
    • Xuzhou, Jiangsu, China, 221009
      • Xuzhou Central Hospital
  • Shangdong
    • Jinan, Shangdong, China, 250012
      • Qilu Hospital of Shandong University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Ruijin Hospital
    • Shanghai, Shanghai Municipality, China, 200072
      • Shanghai Tenth People's Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • "West China School of Medicine /West China Hospital of Sichuan University "
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300211
      • The Second Hospital of Tianjin Medical University
    • Tianjin, Tianjin Municipality, China, 300022
      • Tianjin Chest Hospital
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830054
      • The First Affiliated Hospital of Xinjiang Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Drug treatment group; receive class I or class III AAD to restore or maintain sinus rhythm.	Drug: Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone; Class I or III antiarrhythmic drug, including sotalol
Experimental: cryoballoon ablation group; receive cryoballoon ablation to restore sinus rhythm.	Device: cryoballoon ablation; Pulmonary vein isolation by cryoballoon ablation using Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters (23mm and 28mm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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（Dynamic ECG requires a minimum of 30 seconds, while a 12-lead ECG requires at least 10 seconds.）.	Randomization to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Arrhythmia recurrence during blanking period	atrial tachycardia recurrence rate during the blanking period	3 months
time to first time cardiovascular hospitalization (month)	time to first time cardiovascular hospitalization after treatment (month)	one year
Rate of serious procedure-related and serious cryoablation system-related reported adverse events	Rate of serious procedure-related and serious cryoablation system-related reported adverse events through 12 months after the index ablation procedure	one year

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: Li-qun Wu, MD,PhD, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): August 23, 2025
• Study Completion (Actual): August 23, 2025

Study Registration Dates

• First Submitted: June 17, 2021
• First Submitted That Met QC Criteria: June 20, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2026
• Last Update Submitted That Met QC Criteria: August 17, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: atrial fibrillation; cryoablation; pulmonary vein isolation; Anti-Arrhythmic Agents
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Arrhythmias, Cardiac; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amines; Alcohols; Amino Alcohols; Ethanolamines; Benzofurans; Dronedarone; Amiodarone; Sotalol
• Other Study ID Numbers: Cryo-initial-AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No