Atrial Fibrillation, PersistentCryo-InitialAFNCT04942834
Using Cryoballoon Ablation as Initial Treatment for Persistent Atrial Fibrillation
A study testing Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone and cryoballoon ablation in people with Atrial Fibrillation, Persistent and Arrhythmias, Cardiac, run by Ruijin Hospital at 17 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Persistent, Arrhythmias, Cardiac
- What is being tested?
- Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone and cryoballoon ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 17 sitesChina
- Study dates
- 1 Oct 2021to 23 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
"West China School of Medicine /West China Hospital of Sichuan University "
Chengdu, Sichuan, 610041
Dongguan People's Hospital
Dongguan, Guangdong, 523018
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510120
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, 511466
The Affiliated Hospital Of Guizhou Medical University
Guiyang, Guizhou, 561113
Qilu Hospital Of Shandong University
Jinan, Shangdong, 250012
Nanjing Drum Tower hospital
Nanjing, Jiangsu, 210008
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
Affiliated Hospital Of Nantong University
Nantong, Jiangsu, 226019
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Jiangsu Taizhou People's Hospital
Taizhou, Jiangsu, 225300
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300022
The Second Hospital Of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009
About this study
Official title: 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.
Read the 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.
- Being tested
- Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone, cryoballoon ablation
- Keywords
- cryoablation, pulmonary vein isolation, atrial fibrillation, Anti-Arrhythmic Agents
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and AmiodaroneDrug
Class I or III antiarrhythmic drug, including sotalol
cryoballoon ablationDevice
Pulmonary vein isolation by cryoballoon ablation using Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters (23mm and 28mm)
| Study group | Role | What they receive |
|---|---|---|
| Drug treatment group | Active comparator | receive class I or class III AAD to restore or maintain sinus rhythm. Receives: Drug: Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone |
| cryoballoon ablation group | Experimental | receive cryoballoon ablation to restore sinus rhythm. Receives: Device: cryoballoon ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.）.
Measured: Randomization to 12 months
Secondary outcomes (5)
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)
Measured: 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)
Measured: one year
Arrhythmia recurrence during blanking period
atrial tachycardia recurrence rate during the blanking period
Measured: 3 months
time to first time cardiovascular hospitalization (month)
time to first time cardiovascular hospitalization after treatment (month)
Measured: 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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Oct 2021
- Primary completion23 Aug 2025
- Study completion23 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation, PersistentStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-qun Wu, MD,PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942834
- Sponsor's protocol ID
- Cryo-initial-AF
- Acronym
- Cryo-InitialAF
- Status last verified
- Jul 2025
- First submitted
- 17 Jun 2021
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ling T, Lin Y, Bao Y, Chen L, Xu W, Tang B, Xu J, Zhong J, Li W, Ruan Z, Lu Q, Guo S, Wang J, Han B, Tang K, Liu T, Zeng R, He J, Zhi H, Lin C, Wei Y, Wu Z, Zhang N, Jin Q, Yu Y, Wu L. Cryoballoon ablation vs. antiarrhythmic drug therapy as initial treatment for persistent atrial fibrillation: the multicentre randomized CEPAF trial. Europace. 2026 Sep 2;28(9):euag230. doi: 10.1093/europace/euag230.
PubMed 42677894
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Cryoballoon Ablation as Initial Treatment for Patients With Persistent Atrial Fibrillation Comparing to Anti-arrhythmic Drugs
- ClinicalTrials.gov ID
- NCT04942834
- Acronym / sponsor ID
- Cryo-InitialAF / Cryo-initial-AF
- Keywords
- cryoablation, pulmonary vein isolation, atrial fibrillation, Anti-Arrhythmic Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 23 Aug 2025 (actual)
- Study completion
- 23 Aug 2025 (actual)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug treatment group | Active comparator | Drug: Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodaronereceive class I or class III AAD to restore or maintain sinus rhythm. |
| cryoballoon ablation group | Experimental | Device: cryoballoon ablationreceive cryoballoon ablation to restore sinus rhythm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and AmiodaroneClass I or III antiarrhythmic drug, including sotalol | Drug | Drug treatment group |
| cryoballoon ablationPulmonary vein isolation by cryoballoon ablation using Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters (23mm and 28mm) | Device | cryoballoon ablation group |
Primary outcome
Treatment success at 12 months
Time frame: Randomization to 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.）.
5 secondary outcomes
Quality of life changes at 12 months measured by AFEQT
Time frame: one year
Quality of life changes at 12 months measured by SF-12
Time frame: one year
Arrhythmia recurrence during blanking period
Time frame: 3 months
time to first time cardiovascular hospitalization (month)
Time frame: one year
Rate of serious procedure-related and serious cryoablation system-related reported adverse events
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Derived from this study: PubMed 42677894Ling T, Lin Y, Bao Y, Chen L, Xu W, Tang B, Xu J, Zhong J, Li W, Ruan Z, Lu Q, Guo S, Wang J, Han B, Tang K, Liu T, Zeng R, He J, Zhi H, Lin C, Wei Y, Wu Z, Zhang N, Jin Q, Yu Y, Wu L. Cryoballoon ablation vs. antiarrhythmic drug therapy as initial treatment for persistent atrial fibrillation: the multicentre randomized CEPAF trial. Europace. 2026 Sep 2;28(9):euag230. doi: 10.1093/europace/euag230.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-qun Wu, MD,PhD principal investigator
Ruijin Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone and cryoballoon ablation in people with Atrial Fibrillation, Persistent and Arrhythmias, Cardiac, run by Ruijin Hospital at 17 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success at 12 months (time frame: Randomization to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04942834, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.