Persistent Atrial FibrillationNCT07819175
Pulsed Field Ablation for the Treatment of Persistent Atrial Fibrillation: Pulmonary Vein Plus Superior Vena Cava Isolation Versus Pulmonary Vein Isolation Alone-A Prospective, Multicenter, Randomized Controlled Study
A study testing Pulsed Field Ablation - pulmonary vein isolation and Pulsed Field Ablation - Pulmonary Vein Isolation + Superior Vena Cava Isolation in people with Persistent Atrial Fibrillation, run by Ruijin Hospital at 1 site in China.
Trial summary
his study is for people aged 18 to 75 who have persistent atrial fibrillation (AFib) that has lasted less than one year and who are having their first catheter ablation procedure. Atrial fibrillation is a common heart rhythm problem. 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?
- Pulsed Field Ablation - pulmonary vein isolation and Pulsed Field Ablation - Pulmonary Vein Isolation + Superior Vena Cava Isolation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2026to Oct 2028
- Phase
- Interventional
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
- Persistent atrial fibrillation (AFib) duration < 1 year;
- Age 18-75 years;
- Willing to participate in this study, capable of understanding, and has signed the informed consent form; able to complete postoperative follow-up according to the protocol.
Who cannot join
- Significant cardiac dysfunction or structural abnormality: LVEF < 50% or left atrial anteroposterior diameter > 46 mm;
- Previous left atrial ablation or cardiac surgery (including left atrial appendage closure);
- Presence of permanent pacemaker, CRT, implantable cardiac monitor, or any type of ICD;
- Previous pulmonary vein stent, pulmonary vein stenosis, or superior vena cava stenosis;
- Previous unilateral phrenic nerve palsy;
- Any prosthetic heart valve or moderate-to-severe (grade 3-4) valvular regurgitation/stenosis;
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- Any cardiac surgery, myocardial infarction, PCI/PTCA, or coronary stent implantation within 3 months prior to signing informed consent;
- Unstable angina, NYHA class III/IV heart failure, primary pulmonary hypertension, rheumatic heart disease, or hypertrophic cardiomyopathy;
- Thrombocytosis/thrombocytopenia, any disease contraindicating long-term anticoagulation, active systemic infection;
- Atrial fibrillation due to reversible causes (e.g., hyperthyroidism);
- Stroke or TIA within 6 months prior to signing informed consent;
- Pregnant or lactating women;
- Life expectancy < 1 year;
- Currently participating in or expected to participate in another drug/device/biologic clinical trial during the study period;
- Intracardiac thrombus, drug or alcohol addiction, unwillingness or inability to complete follow-up;
- Severe renal insufficiency (eGFR < 30);
- Previous catheter ablation for atrial fibrillation;
- Primary severe sick sinus syndrome.
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
Ruijin Hostpial Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
About this study
his study is for people aged 18 to 75 who have persistent atrial fibrillation (AFib) that has lasted less than one year and who are having their first catheter ablation procedure.
Atrial fibrillation is a common heart rhythm problem. A standard treatment is a catheter procedure called pulmonary vein isolation (PVI), which uses energy to disconnect the pulmonary veins from the rest of the heart. However, in persistent AFib, the heart rhythm often returns after PVI alone.
Read more
Some people also have abnormal electrical signals coming from a large vein above the right atrium called the superior vena cava (SVC). This study tests whether adding SVC isolation (SVCI) to the standard PVI procedure works better than PVI alone.
The study will use pulsed field ablation (PFA), a newer non-heating technology that targets heart muscle cells and may cause less damage to nearby structures such as the food pipe and nerves.
About 340 participants will be enrolled from around 10 hospitals in China. Using a computer process, half will be assigned to PVI alone and half to PVI plus SVC isolation. Neither the doctor nor the participant will be blinded to the group assignment because the difference between the two procedures is visible.
All participants will be followed for 12 months after the procedure. The main question is: after a 3-month healing period, how many people stay free from AFib and other atrial rhythm problems for the remaining 9 months without needing more ablation or new rhythm medicines? The study also looks at safety, quality of life, hospital stays, and whether the heart rhythm returns.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Pulsed Field Ablation - pulmonary vein isolation, Pulsed Field Ablation - Pulmonary Vein Isolation + Superior Vena Cava Isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Field Ablation - pulmonary vein isolationDevice
Pulsed Field Ablation (PFA) using a commercially available pulsed field ablation catheter to perform pulmonary vein isolation (PVI). Ablation is performed sequentially at each pulmonary vein and the pulmonary vein antrum, with the procedural endpoint of durable bidirectional electrical isolation.
Pulsed Field Ablation - Pulmonary Vein Isolation + Superior Vena Cava IsolationDevice
Pulsed Field Ablation (PFA) using a commercially available pulsed field ablation catheter to perform pulmonary vein isolation (PVI) followed by electrophysiological assessment for superior vena cava (SVC) triggers and additional superior vena cava isolation (SVCI) at the SVC-right atrium junction.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Field Ablation with a catheter for Pulmonary Vein Isolation | Active comparator | Not described Receives: Device: Pulsed Field Ablation - pulmonary vein isolation |
| Pulsed Field Ablation with a catheter for Pulmonary Vein Isolation plus Superior Vena Cava Isolation | Experimental | Not described Receives: Device: Pulsed Field Ablation - Pulmonary Vein Isolation + Superior Vena Cava Isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success from 3 months after the ablation (after the blanking period) through the 12-month follow-up
Measured: 3 months after the ablation (after the blanking period) through the 12-month follow-up
Secondary outcomes (7)
Incidence of atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) during the 3-month blanking period after the index ablation
Measured: From the index ablation through 3 months after the index ablation
Time to first recurrence of atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL)
Measured: From the index ablation through 12 months after the index ablation
Change in quality of life from baseline, as assessed by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT)
Measured: From baseline through 12 months after the index ablation
Change in quality of life from baseline, as assessed by the Atrial Fibrillation Effect on 12-Item Short Form Health Survey (SF-12) scores
Measured: From baseline through 12 months after the index ablation
Incidence of cardiovascular-related rehospitalization
Measured: From the index ablation through 12 months after the index ablation
Proportion of participants undergoing repeat catheter ablation
Measured: From the index ablation through 12 months after the index ablation
Composite of perioperative complications and serious adverse events (SAEs) within 30 days after the index ablation
Measured: From the index ablation through 30 days after the index ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start8 Oct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (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 Ruijin HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WU LIQUN, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819175
- Sponsor's protocol ID
- PULSED-SVC Trial
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes