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Can a freezing balloon beat drugs for persistent AF?

NCT ID NCT04942834

Disease control Sponsor: Ruijin Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial tests whether using cryoballoon ablation as the first treatment for persistent atrial fibrillation (AF) is more effective and safer than starting with anti-arrhythmic drugs. Adults aged 18-75 with symptomatic persistent AF and a structurally normal heart are eligible. Participants are randomly assigned to receive either cryoballoon ablation or drug therapy, and the study tracks freedom from AF recurrence and quality of life over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cryoballoon ablation (a procedure using a balloon cooled to freeze heart tissue) compared with anti-arrhythmic drugs (propafenone, sotalol, dronedarone, amiodarone)
What this could lead to
If cryoballoon ablation works better than drugs as a first treatment, it could become a preferred option for persistent AF, potentially reducing the need for long-term medication and improving quality of life.
What could go wrong
This is a single-center trial, and results may not apply to all patients. Ablation carries risks like bleeding, infection, or heart damage, and AF may still return.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

320 people

The number who actually took part.

Started

Oct 2021

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac atrial fibrillation cardiac rhythm disease persistent atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arrhythmias, cardiac Atrial fibrillation, persistent

Contacts and locations

Locations

  • "West China School of Medicine /West China Hospital of Sichuan University "

    Chengdu, Sichuan, 610041, China

  • Affiliated Hospital Of Nantong University

    Nantong, Jiangsu, 226019, China

  • Dongguan People's Hospital

    Dongguan, Guangdong, 523018, China

  • Fujian Provincial Hospital

    Fuzhou, Fujian, 350001, China

  • Jiangsu Taizhou People's Hospital

    Taizhou, Jiangsu, 225300, China

  • Nanjing Drum Tower hospital

    Nanjing, Jiangsu, 210008, China

  • Qilu Hospital Of Shandong University

    Jinan, Shangdong, 250012, China

  • Ruijin Hospital

    Shanghai, Shanghai Municipality, 200025, China

  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai Municipality, 200072, China

  • Sun Yat-sen Memorial Hospital

    Guangzhou, Guangdong, 510120, China

  • The Affiliated Hospital Of Guizhou Medical University

    Guiyang, Guizhou, 561113, China

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054, China

  • The First Affiliated Hospital,Sun Yat-sen University

    Guangzhou, Guangdong, 511466, China

  • The Second Hospital Of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211, China

  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality, 300022, China

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221009, China

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009, China

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