Using Cryoballoon Ablation as Initial Treatment for Persistent Atrial Fibrillation

Arrhythmias, Cardiac Clinical Trial

— Cryo-InitialAF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04942834
• Other study ID #: Cryo-initial-AF
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: January 2026

Study information

• Verified date: August 2023
• Source: Ruijin Hospital
• Contact: Li-qun Wu, MD,PhD
• Phone: +8613801621534
• Email: wuliqun89[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Atrial Fibrillation, Persistent

Intervention

Drug:
• Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone
Class I or III antiarrhythmic drug, including sotalol

Device:
• cryoballoon ablation
Pulmonary vein isolation by cryoballoon ablation using Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters (23mm and 28mm)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

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