Paroxysmal Atrial Fibrillation (PAF)Balloon cryoabNCT07036068
A Clinical Study on the Use of a Domestically Produced Cryoablation System Combined With Balloon Cryoablation Technology for the Treatment of Paroxysmal Atrial Fibrillation
A study testing IceMagic™ CryoAblation Catheter in people with Paroxysmal Atrial Fibrillation (PAF), run by Shanghai MicroPort EP MedTech Co., Ltd. at 1 site in China.
Trial summary
To validate the safety and efficacy of balloon cryoablation technology and the accompanying disposable intracardiac mapping electrode catheter and adjustable guide sheath for the treatment of paroxysmal atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation (PAF)
- What is being tested?
- IceMagic™ CryoAblation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age between 18 and 80 years old, male or non-pregnant female.
- Confirmed diagnosis of paroxysmal atrial fibrillation requiring cryoablation surgery.
- Fully understands the treatment plan and voluntarily signs the informed consent form, willing to undergo the examinations, surgery, and follow-up required by the plan.
Who cannot join
- Patients who have undergone atrial fibrillation ablation surgery
- Reproductive-age patients who cannot use effective contraception within 12 months of enrolment
- Left atrial size ≥50 mm, left ventricular ejection fraction ≤40%
- Left atrial thrombus
- Patients who have undergone atrial septal defect repair surgery or atrial myxoma
- Patients with cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack)
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- Patients with cardiovascular events within the past 3 months (including acute myocardial infarction, coronary artery intervention or bypass surgery, artificial valve replacement or repair, or atrial or ventricular incision)
- Patients with acute or severe systemic infection
- Patients with severe liver or kidney disease
- Patients with a significant tendency to bleed or haematological disorders
- Patients with malignant tumours or end-stage diseases
- Patients deemed ineligible for this trial by the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Kaijun K Cui, PhD, 028-60660000, hxjj@cd120.com
About this study
To validate the safety and efficacy of balloon cryoablation technology and the accompanying disposable intracardiac mapping electrode catheter and adjustable guide sheath for the treatment of paroxysmal atrial fibrillation.
- Conditions
- Paroxysmal Atrial Fibrillation (PAF)
- Being tested
- IceMagic™ CryoAblation Catheter
- Keywords
- PFA, PeAF, PFA/RF
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IceMagic™ CryoAblation CatheterDevice
IceMagic™ CryoAblation Catheter is available in two diameters: 23 mm and 28 mm. Each diameter has two types of balloon outer surfaces: with or without multi-channel tissue temperature measurement function. The catheter length is 140 cm, and the tube diameter is 10.5 F. Doctors can choose according to the size of the target pulmonary vein.
| Study group | Role | What they receive |
|---|---|---|
| Single-centre, post-marketing study | Experimental | This study aims to evaluate the safety and efficacy of using a domestically produced cardiac cryoablation system to treat paroxysmal atrial fibrillation. Receives: Device: IceMagic™ CryoAblation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-month follow-up success rate after surgery
Postoperative 3-month treatment success rate: Specifically refers to the proportion of participants who, during the 3-month follow-up period post-surgery (after the washout period), did not experience any episodes of atrial fibrillation/atrial flutter/atrial tachycardia lasting ≥30 seconds, as confirmed by electrocardiogram (ECG), Holter monitoring, or equivalent rhythm monitoring methods (including single-lead ECG), without the use of Class I or Class III antiarrhythmic drugs, relative to the total number of enrolled participants.
Measured: Three months after surgery
Secondary outcomes (1)
Immediate ablation success rate
This refers to the proportion of subjects who achieved electrical isolation after surgery among the total number of patients enrolled in the study. The verification method involves waiting for 20 minutes after successful pulmonary vein electrical isolation and then reconfirming pulmonary vein conduction block.
Measured: On the 1 day of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start31 Aug 2025 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial Fibrillation (PAF)Studies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Gao Henggan, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036068
- Sponsor's protocol ID
- West China Hospital（Sichuan）
- Acronym
- Balloon cryoab
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Use of a Domestically Produced Cryoablation System Combined With Balloon Cryoablation Technology for the Treatment of Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07036068
- Acronym / sponsor ID
- Balloon cryoab / West China Hospital（Sichuan）
- Conditions
- Paroxysmal Atrial Fibrillation (PAF)
- Keywords
- PFA, PeAF, PFA/RF
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2025 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Jun 2025 (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.
To validate the safety and efficacy of balloon cryoablation technology and the accompanying disposable intracardiac mapping electrode catheter and adjustable guide sheath for the treatment of paroxysmal atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-centre, post-marketing study | Experimental | Device: IceMagic™ CryoAblation CatheterThis study aims to evaluate the safety and efficacy of using a domestically produced cardiac cryoablation system to treat paroxysmal atrial fibrillation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient age between 18 and 80 years old, male or non-pregnant female.
- Confirmed diagnosis of paroxysmal atrial fibrillation requiring cryoablation surgery.
- Fully understands the treatment plan and voluntarily signs the informed consent form, willing to undergo the examinations, surgery, and follow-up required by the plan.
Key exclusion criteria (12 listed)
- Patients who have undergone atrial fibrillation ablation surgery
- Reproductive-age patients who cannot use effective contraception within 12 months of enrolment
- Left atrial size ≥50 mm, left ventricular ejection fraction ≤40%
- Left atrial thrombus
- Patients who have undergone atrial septal defect repair surgery or atrial myxoma
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 |
|---|---|---|
| IceMagic™ CryoAblation CatheterIceMagic™ CryoAblation Catheter is available in two diameters: 23 mm and 28 mm. Each diameter has two types of balloon outer surfaces: with or without multi-channel tissue temperature measurement function. The catheter length is 140 cm, and the tube diameter is 10.5 F. Doctors can choose according to the size of the target pulmonary vein. | Device | Single-centre, post-marketing study |
Primary outcome
Three-month follow-up success rate after surgery
Time frame: Three months after surgery
Postoperative 3-month treatment success rate: Specifically refers to the proportion of participants who, during the 3-month follow-up period post-surgery (after the washout period), did not experience any episodes of atrial fibrillation/atrial flutter/atrial tachycardia lasting ≥30 seconds, as confirmed by electrocardiogram (ECG), Holter monitoring, or equivalent rhythm monitoring methods (including single-lead ECG), without the use of Class I or Class III antiarrhythmic drugs, relative to the total number of enrolled participants.
1 secondary outcome
Immediate ablation success rate
Time frame: On the 1 day of the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IceMagic™ CryoAblation Catheter in people with Paroxysmal Atrial Fibrillation (PAF), run by Shanghai MicroPort EP MedTech Co., Ltd. at 1 site 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 3 inclusion and 12 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: opening soon, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaijun K Cui, PhD (028-60660000, hxjj@cd120.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three-month follow-up success rate after surgery (time frame: Three months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2025.