NCT06232798Completed
A Dual Energy Catheter (PFA and RFA) and a PFA Catheter for the Treatment of PeAF
A Single-Center, Exploratory Clinical Study Combining Radiofrequency and Pulsed Field Ablation for Persistent Atrial Fibrillation Based on Columbus™ 3D EP Navigation System
Source: ClinicalTrials.gov · Last updated 21 May 2025
Brief summary (registry, in English)
The goal of this clinical trial is to treatment of patients with persistent atrial fibrillation with PFA/RFA. 10 patients will be treated by PFA/RFA catheter or PFA catheter only. Participants will followed 1、3 month after catheter ablation
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 18 Jan 2024
- Start date
- 11 Jan 2024
- Primary completion date
- 10 Sept 2024
- Lead sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
- Diseases
- Atrial fibrillation
- NCT number
- NCT06232798
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 11 Jan 2024 to the primary completion date, 10 Sept 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
- 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 3-month period following enrollment
Other
- Patients with combined atrial tachycardia and atypical atrial flutter
- Anterior and posterior left atrial diameter ≥ 55mm
Who the study is looking for
- Aged 18-75 years old;
- Documented symptomatic persistent atrial fibrillation, defined as persistent atrial fibrillation lasting more than 7 days and less than 1 year;
- Ineffective or intolerable after treatment with at least one Class I or Class III antiarrhythmic drug;
- 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 |
|---|---|---|---|
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.