NCT05618340Completed
3-Dimensional Mapping System: The PULSTAR Study
Pulsed Field Ablation Paroxysmal Atrial Fibrillation Using a Novel Spiral Catheter Integrated With a 3-Dimensional Mapping System: The PULSTAR Study
Source: ClinicalTrials.gov · Last updated 24 Jul 2025
Brief summary (registry, in English)
The purpose of this study is to verify the safety and efficacy of the cardiac pulse ablation system in paroxysmal atrial fibrillation to provide the basis for product registration and clinical application. The trial will be conducted at a clinical center with appropriate clinical cases, and paroxysmal atrial fibrillation ablation procedures will be performed by an authorized investigator using the trial product. The effectiveness and safety of the cardiac pulse ablation system in the treatment of paroxysmal atrial fibrillation will be verified by collecting the treatment success rate, immediate ablation success rate, procedure time and device use evaluation within 12 months after the procedure.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 149 (actual)
- First submitted
- 6 Nov 2022
- Start date
- Sept 2022
- Primary completion date
- Mar 2024
- Lead sponsor
- Shanghai Shangyang Medical Technology Co., Ltd.
- Diseases
- Atrial fibrillation
- NCT number
- NCT05618340
What you commit to
- Study type: Interventional
- Participants enrolled: 149
- From Sept 2022 to the primary completion date, Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have undergone left atrial surgery
- Previous atrial septal repair or atrial mucinous tumor
- Active implants (e.g. pacemakers, ICDs, etc.) in the body
- Patients who have participated or are participating in other clinical trials within 3 months prior to enrollment
Other illness
- Left atrial thrombosis
- NYHA class III-IV cardiac function \[Appendix 1\]
- Clear cerebrovascular disease within the last 6 months (including cerebral hemorrhage, stroke, transient ischemic attack)
- Cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy)
- Those with acute or severe systemic infections
- Patients with severe liver or kidney disease, malignant tumors or end-stage disease that, in the opinion of the investigator, may interfere with the treatment, evaluation and compliance of this trial
- Patients with significant bleeding tendency, hypercoagulable state and severe hematologic disorders
- Patients who have other conditions that the investigator considers inappropriate for participation in this trial.
Lab values
- Left ventricular ejection fraction (LVEF) ≤ 40%
Age
- Patients of childbearing age who are unable to use effective contraception during the 12-month period after enrollment
Other
- Anterior and posterior left atrial diameter ≥ 50 mm
Who the study is looking for
- ≥18 and ≤75 years of age.
- Paroxysmal atrial fibrillation diagnosed by electrocardiogram or Holter ECG (including single-lead ECG recorder, lasting≥30s) within 1 year prior to enrollment.
- Clinical diagnosis of paroxysmal atrial fibrillation.
- Symptomatic patients who are ineffective or intolerant to at least one antiarrhythmic medication; or patients who are willing to undergo ablation despite not being on medication.
- Fully understand the treatment protocol and voluntarily sign the informed consent form and be willing to undergo the tests, procedures and follow-ups required by the protocol.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| General Hospital of Northern Theater Command, No. 83 Wenhua Road, Shenhe District, Shenyang, Liaoning Province Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.