A Dual Energy Catheter (PFA and RFA) and a PFA Catheter for the Treatment of PeAF (PFA，RFA，PeAF)
May 20, 2025 updated by: Shanghai MicroPort EP MedTech Co., Ltd.
A Single-Center, Exploratory Clinical Study Combining Radiofrequency and Pulsed Field Ablation for Persistent Atrial Fibrillation Based on Columbus™ 3D EP Navigation System
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
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- West China Hospital of Sichuan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who have undergone left atrial surgery
- Left atrial thrombosis
- Patients with combined atrial tachycardia and atypical atrial flutter
- Patients of childbearing age who are unable to use effective contraception during the 3-month period following enrollment
- Anterior and posterior left atrial diameter ≥ 55mm
- Left ventricular ejection fraction (LVEF) ≤ 40%
- Previous atrial septal repair or atrial mucinous tumor
- Active implants (e.g. pacemakers, ICDs, etc.) in the body
- 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 participated or are participating in other clinical trials within 3 months prior to enrollment
- Patients who have other conditions that the investigator considers inappropriate for participation in this trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A prospective, singlecenter, single-arm clinical study
|
This study will be used two catheters, the contact force sensing catheter able to deliver both RF and PFA energy, this catheter provides both the radiofrequency (RF) energy and pulsed field ablation (PFA) energy to the catheter through the toggling of the two energy sources on the generator monitor.
Another catheter is PFA catheter only.
catheter ablation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Immediate success rate
Time Frame: 1 Day of catheter ablation
|
Refers to the proportion of the number of subjects electrically isolated in each AF patient after surgery to the total number of subjects enrolled.
|
1 Day of catheter ablation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ablation success at 3-month after the catheter ablation
Time Frame: 3 months
|
Ablation success is defined as no recurrence with no anti-arrhythmic drugs by taking history of symptoms from the patient and by Holter 24 Hours.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 11, 2024
Primary Completion (Actual)
September 10, 2024
Study Completion (Actual)
April 30, 2025
Study Registration Dates
First Submitted
January 18, 2024
First Submitted That Met QC Criteria
January 30, 2024
First Posted (Actual)
January 31, 2024
Study Record Updates
Last Update Posted (Actual)
May 21, 2025
Last Update Submitted That Met QC Criteria
May 20, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 775046
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.