Persistent Atrial FibrillationNCT06671197
Study on the Ablation of Persistent Atrial Fibrillation Using Pulsed Electric Fields Under Different Surgical Procedures
An observational study of Persistent Atrial Fibrillation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Atrial fibrillation (AF) is one of the most common arrhythmias in clinical practice, and there are more than 20 million AF patients in my country. Currently, rhythm control has become the main treatment option for AF, but there is still controversy over the best ablation procedure, especially whether other auxiliary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Pulmonary vein isolation and Pulmonary vein isolation+posterior left atrial wall line+superior vena cava isolation
- Type of treatment
- Medical device
- How many people
- 436 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2025to 31 Mar 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1.18 years old and above, regardless of gender; 2.Patients with symptomatic drug-refractory persistent atrial fibrillation (diagnosis time exceeding ≤ 3 years); 3.Agree to participate in the study and be able and willing to comply with all follow-up requirements
Who may be able to join
- 18 years old and above, regardless of gender;
- Patients with symptomatic drug-refractory persistent atrial fibrillation (diagnosis time exceeding ≤ 3 years);
- Agree to participate in the study and be able and willing to comply with all follow-up requirements;-
Who cannot join
- Left ventricular ejection fraction (LVEF) ≤ 35%
- Left atrial diameter (echocardiography) ≥ 55mm
- Patients with a definite thrombus in the left atrium or a definite thrombus in the heart before surgery
- Patients with cardiac function classification (NYHA) III-IV
- Patients with second-degree (type II) or third-degree atrioventricular block
- Persons with obvious congenital heart defects (such as atrial septal defect or severe pulmonary vein stenosis, but excluding patent foramen ovale)
Show all 19Show fewer
- Patients with prosthetic valve implantation
- Patients with implanted cardiac pacemaker or cardiac defibrillator (ICD)
- Diagnosed with hypertrophic cardiomyopathy, chronic obstructive pulmonary disease, myxoma
- Patients with preoperatively known symptomatic carotid stenosis
- Patients with untreated or controlled hyperthyroidism or hypothyroidism
- Patients with systemically active infections
- Patients with renal failure who have significant bleeding tendency or are undergoing hemodialysis
- Patients with myocardial infarction or any cardiac intervention/open surgery within 3 months
- Patients who have had a stroke or transient ischemic attack within 6 months
- Patients with obvious contraindications to interventional surgery and who are judged by the investigator to be unable to undergo ablation surgery
- Women who are pregnant or breastfeeding or who have a family planning during the study period
- Patients who have participated in clinical trials of other drugs or medical devices within 3 months
- Patients considered inappropriate by the investigator to participate in this clinical trial -
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
Sichuan Jinjiang Electronic Medical Device Technology Co., Ltd
Chengdu, Sichuan
XINlin Yang, 15258090991, 15258090991@163.com
About this study
Official title: Multicenter Randomized Controlled Study on Efficacy and Safety of Pulmonary Vein Isolation,Left Atrial Posterior Wall Ablation and Superior Vena Cava Isolation Using Pulsed Field Ablation for Persistent Atrial Fibrillation
Atrial fibrillation (AF) is one of the most common arrhythmias in clinical practice, and there are more than 20 million AF patients in my country. Currently, rhythm control has become the main treatment option for AF, but there is still controversy over the best ablation procedure, especially whether other auxiliary ablation lines need to be added. Based on the existing clinical evidence, the durability and permeability of ablation damage are the main reasons for the differences. Pulsed electric field is a new ablation energy source based on the principle of cell electroporation. It has the characteristics of damage safety and permeability, so it is expected to solve the above dilemma. The study was divided into PVI (PVI-only) group according to the ratio of 1: 1, PVI + PWI + SVCI (posterior left atrial wall isolation and superior vena cava isolation) group. Through one-year follow-up of two groups of patients, the role of left atrial posterior wall and superior vena cava in the maintenance mechanism of persistent atrial fibrillation was explored, and the safety and effectiveness of domestic pulse ablation system were verified, which provided intellectual support for further medical and engineering integration
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Pulmonary vein isolation, Pulmonary vein isolation+posterior left atrial wall line+superior vena cava isolation
- Keywords
- Pulsed Field Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolationDevice
Pulsed field ablation
Pulmonary vein isolation+posterior left atrial wall line+superior vena cava isolationDevice
Pulsed field ablation
| Study group | Role | What they receive |
|---|---|---|
| PVI-only | Not described Receives: Device: Pulmonary vein isolation | |
| PVI + PWI + SVCI | posterior left atrial wall isolation and superior vena cava isolation Receives: Device: Pulmonary vein isolation+posterior left atrial wall line+superior vena cava isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical success rate
Surgical success rate: Except for the blank period, there was no recurrence of atrial arrhythmia ≥30s within 12 months after surgery.
Measured: 12 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start31 Mar 2025 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 436 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671197
- Sponsor's protocol ID
- 20240926
- Status last verified
- Mar 2025
- First submitted
- 27 Sep 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Study on Efficacy and Safety of Pulmonary Vein Isolation,Left Atrial Posterior Wall Ablation and Superior Vena Cava Isolation Using Pulsed Field Ablation for Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06671197
- Acronym / sponsor ID
- 20240926
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Pulsed Field Ablation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 436 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 31 Mar 2025 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 4 Nov 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.
Atrial fibrillation (AF) is one of the most common arrhythmias in clinical practice, and there are more than 20 million AF patients in my country. Currently, rhythm control has become the main treatment option for AF, but there is still controversy over the best ablation procedure, especially whether other auxiliary ablation lines need to be added. Based on the existing clinical evidence, the durability and permeability of ablation damage are the main reasons for the differences. Pulsed electric field is a new ablation energy source based on the principle of cell electroporation. It has the characteristics of damage safety and permeability, so it is expected to solve the above dilemma. The study was divided into PVI (PVI-only) group according to the ratio of 1: 1, PVI + PWI + SVCI (posterior left atrial wall isolation and superior vena cava isolation) group. Through one-year follow-up of two groups of patients, the role of left atrial posterior wall and superior vena cava in the maintenance mechanism of persistent atrial fibrillation was explored, and the safety and effectiveness of domestic pulse ablation system were verified, which provided intellectual support for further medical and engineering integration
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI-only | – | Device: Pulmonary vein isolation |
| PVI + PWI + SVCI | – | Device: Pulmonary vein isolation+posterior left atrial wall line+superior vena cava isolationposterior left atrial wall isolation and superior vena cava isolation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1.18 years old and above, regardless of gender; 2.Patients with symptomatic drug-refractory persistent atrial fibrillation (diagnosis time exceeding ≤ 3 years); 3.Agree to participate in the study and be able and willing to comply with all follow-up requirements
Key inclusion criteria (3 listed)
- 18 years old and above, regardless of gender;
- Patients with symptomatic drug-refractory persistent atrial fibrillation (diagnosis time exceeding ≤ 3 years);
- Agree to participate in the study and be able and willing to comply with all follow-up requirements;-
Key exclusion criteria (19 listed)
- Left ventricular ejection fraction (LVEF) ≤ 35%
- Left atrial diameter (echocardiography) ≥ 55mm
- Patients with a definite thrombus in the left atrium or a definite thrombus in the heart before surgery
- Patients with cardiac function classification (NYHA) III-IV
- Patients with second-degree (type II) or third-degree atrioventricular block
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 |
|---|---|---|
| Pulmonary vein isolationPulsed field ablation | Device | PVI-only |
| Pulmonary vein isolation+posterior left atrial wall line+superior vena cava isolationPulsed field ablation | Device | PVI + PWI + SVCI |
Primary outcome
Surgical success rate
Time frame: 12 months after surgery.
Surgical success rate: Except for the blank period, there was no recurrence of atrial arrhythmia ≥30s within 12 months after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Atrial Fibrillation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 3 inclusion and 19 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: opening soon, as of the sponsor's last update on 14 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youqi FAN, Chief physician (+86 13867482684, fanyq@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical success rate (time frame: 12 months after surgery.). 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 14 Mar 2025.