Using Cryoballoon Ablation as Initial Treatment for Persistent Atrial Fibrillation

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital
• Treatments: Amiodarone; Anti-Arrhythmia Agents; Dronedarone; Propafenone; Sotalol

Criteria

Inclusion Criteria:

• Documentation of symptomatic persistent AF: Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by consecutive ECG recordings OR Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by an ECG recording and one doctor note indicating patient had symptoms consistent with AF

• Age 18 or older (or older than 18 if required by local law)

• 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