Persistent Atrial FibrillationPFA，RFA，PeAFNCT06232798
A Dual Energy Catheter (PFA and RFA) and a PFA Catheter for the Treatment of PeAF
A study testing a dual energy catheter (RF and PFA) or PFA catheter only will be to treat PeAF,Cardiac Pulsed Electric Field Ablation Catheter and catheter ablation in people with Persistent Atrial Fibrillation, run by Shanghai MicroPort EP MedTech Co., Ltd. at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- a dual energy catheter (RF and PFA) or PFA catheter only will be to treat PeAF,Cardiac Pulsed Electric Field Ablation Catheter and catheter ablation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- 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.
Who cannot join
- 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%
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- a dual energy catheter (RF and PFA) or PFA catheter only will be to treat PeAF,Cardiac Pulsed Electric Field Ablation Catheter, catheter ablation
- 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.
a dual energy catheter (RF and PFA) or PFA catheter only will be to treat PeAF,Cardiac Pulsed Electric Field Ablation CatheterOther
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 ablationOther
Also called operation
catheter ablation
| Study group | Role | What they receive |
|---|---|---|
| A prospective, singlecenter, single-arm clinical study | Experimental | Not described Receives: Other: a dual energy catheter (RF and PFA) or PFA catheter only will be to treat PeAF,Cardiac Pulsed Electric Field Ablation Catheter; Other: catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate success rate
Refers to the proportion of the number of subjects electrically isolated in each AF patient after surgery to the total number of subjects enrolled.
Measured: 1 Day of catheter ablation
Secondary outcomes (1)
Ablation success at 3-month after the catheter ablation
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start11 Jan 2024
- Primary completion10 Sep 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies 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
- Model description
- A prospective, singelcenter, single-arm clinical study to evaluate the safety and efficacy of PFA/RF catheter or PFA catheter for the treatment of persistent atrial fibrillation
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232798
- Sponsor's protocol ID
- 775046
- Acronym
- PFA，RFA，PeAF
- Status last verified
- May 2025
- First submitted
- 18 Jan 2024
- Last updated
- 21 May 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 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Exploratory Clinical Study Combining Radiofrequency and Pulsed Field Ablation for Persistent Atrial Fibrillation Based on Columbus™ 3D EP Navigation System
- ClinicalTrials.gov ID
- NCT06232798
- Acronym / sponsor ID
- PFA，RFA，PeAF / 775046
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- PFA, PeAF, PFA/RF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 31 Jan 2024 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, singelcenter, single-arm clinical study to evaluate the safety and efficacy of PFA/RF catheter or PFA catheter for the treatment of persistent atrial fibrillation
| Arm | Type | Receives |
|---|---|---|
| A prospective, singlecenter, single-arm clinical study | Experimental | Other: a dual energy catheter (RF and PFA) or PFA catheter only will be to treat PeAF,Cardiac Pulsed Electric Field Ablation Catheter, Other: catheter ablation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| a dual energy catheter (RF and PFA) or PFA catheter only will be to treat PeAF,Cardiac Pulsed Electric Field Ablation CatheterThis 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. | Other | A prospective, singlecenter, single-arm clinical study |
| catheter ablationAlso: operationcatheter ablation | Other | A prospective, singlecenter, single-arm clinical study |
Primary outcome
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 secondary outcome
Ablation success at 3-month after the catheter ablation
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a dual energy catheter (RF and PFA) or PFA catheter only will be to treat PeAF,Cardiac Pulsed Electric Field Ablation Catheter and catheter ablation in people with Persistent Atrial Fibrillation, 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 4 inclusion and 16 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: finished, as of the sponsor's last update on 21 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate success rate (time frame: 1 Day of catheter ablation). 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 21 May 2025.