Paroxysmal Atrial Fibrillation (PAF)NCT07862972
Cryoballoon Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation
An observational study of Paroxysmal Atrial Fibrillation (PAF), run by Shenyang Northern Hospital at 1 site in China.
Trial summary
This post-marketing, multi-center, prospective, single-arm, observational study will be conducted across 3 clinical sites in China and enroll no more than 50 patients with paroxysmal atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation (PAF)
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2026to 30 Oct 2027
- Phase
- Observational
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
Study population: Patients (aged 18-75 years) was documented paroxysmal atrial fibrillation (PAF), eligible for AF catheter ablation, and scheduled to undergo a cryoballoon-based pulmonary vein isolation.
Who may be able to join
- Aged 18-75 years.
- Documented paroxysmal atrial fibrillation (PAF), eligible for AF catheter ablation, and scheduled to undergo a cryoballoon-based pulmonary vein isolation.
- Willing and able to complete all protocol-required study visits and assessments.
- Ability to understand the study procedures and provide written informed consent.
Who cannot join
- Prior AF ablation (catheter-based), left atrial maze procedure, or any other pulmonary vein/left atrial intervention;
- Left atrial (LA) diameter >55 mm, or severe valvular heart disease requiring surgical intervention;
- Left ventricular ejection fraction < 40%;
- Stroke, transient ischemic attack (TIA), acute coronary syndrome (ACS), Myocardial infarction (MI), Any cardiac surgical or percutaneous cardiac procedure within the last three months;
- Left atrial/left atrial appendage thrombus;
- Severe liver and/or renal insufficiency;
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- With bleeding tendency, contraindication for anticoagulation, or inability to tolerate oral anticoagulant therapy.
- Pregnant or breastfeeding women;
- with cryoglobulinemia;
- Hypersensitivity reactions to contrast media;
- Any factor that, in the investigator's judgment, renders the patient unsuitable for participation (such as mental illness, or inability to complete follow-up, etc.).
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
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110000
Yaling Han, +86-24-23922184, cardiology@163.com
Zulu Wang, wangzulu62@126.com
About this study
Official title: Assessment of Pulmonary Vein Isolation Using the Cryoballoon in Paroxysmal Atrial Fibrillation: A Multi-center, Prospective Observational Clinical Study
This post-marketing, multi-center, prospective, single-arm, observational study will be conducted across 3 clinical sites in China and enroll no more than 50 patients with paroxysmal atrial fibrillation. After clinical site initiation, each study site was permitted to enroll up to 2 roll-in cases to allow operators to familiarize themselves with the Nordica® cryoballoon and standardize procedural techniques. A competitive enrollment method will be adopted to recruit up to 50 patients with paroxysmal atrial fibrillation. The Nordica® cryoballoon will be employed for pulmonary vein isolation during the procedure. A 6-month follow-up assessment is scheduled at the following time points: the index hospitalization period (days 0-3), and post-procedure follow-up time points at 30 days, 3 months, and 6 months.
Read the detailed description
Cryoballoon ablation has become an initial therapy for patients with paroxysmal atrial fibrillation, owing to its advantages of procedural standardization, high intraoperative comfort, reliable pulmonary vein isolation, and favorable safety profile. The Nordica® balloon features a single-layer design, offering superior compliance compared to double-layer balloons. This facilitates transmural pulmonary vein isolation (PVI) and reduces the likelihood of segmental ablation and adjacent tissue injury. The balloon maintains an internal pressure of 3 psi or 5 psi with high leak resistance, a design that prevents displacement caused by sudden pressure spikes during ablation and minimizes failures in pulmonary vein isolation due to inadequate contact. Furthermore, the compliant design of the Nordica® balloon conforms better to pulmonary vein anatomy, enabling easy occlusion of the pulmonary veins without the need for additional pushing force. It has been approved for pulmonary vein isolation in this patient population. Previous studies have demonstrated the safety and efficacy of the Nordica® cryoballoon in the treatment of paroxysmal atrial fibrillation. Nevertheless, there is still a lack of multi-center, prospective real-world evidence on the long-term effectiveness, safety, procedural efficiency, and health economic value of the Nordica® cryoballoon in routine clinical practice Therefore, we aim to conduct a multi-center, prospective, single-arm, observational real-world study to assess the post-marketing safety, effectiveness, procedural efficiency, and health economic outcomes of the Nordica® cryoballoon for pulmonary vein isolation in patients with paroxysmal atrial fibrillation, with the goal of developing high-quality, evidence-based guidelines to inform its standardized use in clinical practice.
- Conditions
- Paroxysmal Atrial Fibrillation (PAF)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AF catheter ablation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of 30-day postoperative complications
Including any of the following adverse events：
- Death (including all-cause mortality and cardiovascular death)；
- Stroke/ transient ischemic attack;
- Pericardial tamponade / Pericardial Effusion (need drainage or surgical removal)；
- major vascular complications / major bleeding events (resulting in death, blood transfusion, prolonged hospitalization, or surgical/interventional treatment)； 5) major vascular complications (requires repair, intervention, or blood transfusion); 6) Symptomatic pulmonary vein stenosis (requires intervention/ surgery); 7) atrioesophageal fistula/ esophageal injury;
8）persistent phrenic nerve injury (persisting beyond 7 days following the index procedure); 9）Severe arrhythmia (requires cardioversion/emergency drug treatment)
Measured: Within 30 days postoperatively
Incidence of freedom from atrial arrhythmia at 6 months postoperatively
Defined as the proportion of subjects free from any documented atrial tachyarrhythmia - including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) lasting ≥30 seconds - occurring. These episodes must be confirmed by 12-lead electrocardiogram (ECG) and seven-day Holter monitoring following a 6-month period post-ablation.
Measured: At 6 months postoperatively
Secondary outcomes (4)
Acute success rate of pulmonary vein isolation
Defined as the proportion of subjects with confirmed complete isolation of all pulmonary veins.
Measured: Intraoperative
The extended major safety endpoints, minor adverse events, and other medical device adverse event or procedure-related adverse event
- Transient phrenic nerve palsy (requiring brief intervention therapy, recovered prior to discharge);
- Minor vascular access complications (without intervention/ surgery);
- Minor bleeding (without transfusion, surgical/interventional treatment);
- Asymptomatic pulmonary vein stenosis (without intervention);
- Non-serious cardiovascular and pulmonary medical device and/or procedure-related adverse events;
- medical device related adverse events (e.g., mild vascular irritation related to catheter manipulation; device performance anomaly without serious clinical sequelae)
Measured: Intraoperative/within 30 days postoperatively/at 6 months postoperatively
Procedure efficiency
Will be described using (mean, median, and distribution): total procedure room time, procedure time, pulmonary vein isolation time, left atrial dwell time, the length of hospital stay (LOS), ablation time, the number of ablation applications, time to isolation (TTI), and fluoroscopy time, fluoroscopy dose.
Measured: Intraoperative
Health economics
Will be described using (mean and distribution): direct medical costs of subjects (procedure cost, device cost, examination costs, medication costs, hospitalization costs, etc.).
Measured: From enrollment to the end of treatment at 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Oct 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Chest Hospital, The First Hospital of Jilin University
- Responsible party
- Principal investigator, Han Yaling, Shenyang Northern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862972
- Sponsor's protocol ID
- SNPPMC-0018
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No