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

September 8, 2026 updated by: WU LIQUN, Ruijin Hospital

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

340

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 Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Ruijin Hostpial Shanghai Jiaotong University School of Medicine

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:

  1. Persistent atrial fibrillation (AFib) duration < 1 year;
  2. Age 18-75 years;
  3. 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.

Exclusion Criteria:

  1. Significant cardiac dysfunction or structural abnormality: LVEF < 50% or left atrial anteroposterior diameter > 46 mm;
  2. Previous left atrial ablation or cardiac surgery (including left atrial appendage closure);
  3. Presence of permanent pacemaker, CRT, implantable cardiac monitor, or any type of ICD;
  4. Previous pulmonary vein stent, pulmonary vein stenosis, or superior vena cava stenosis;
  5. Previous unilateral phrenic nerve palsy;
  6. Any prosthetic heart valve or moderate-to-severe (grade 3-4) valvular regurgitation/stenosis;
  7. Any cardiac surgery, myocardial infarction, PCI/PTCA, or coronary stent implantation within 3 months prior to signing informed consent;
  8. Unstable angina, NYHA class III/IV heart failure, primary pulmonary hypertension, rheumatic heart disease, or hypertrophic cardiomyopathy;
  9. Thrombocytosis/thrombocytopenia, any disease contraindicating long-term anticoagulation, active systemic infection;
  10. Atrial fibrillation due to reversible causes (e.g., hyperthyroidism);
  11. Stroke or TIA within 6 months prior to signing informed consent;
  12. Pregnant or lactating women;
  13. Life expectancy < 1 year;
  14. Currently participating in or expected to participate in another drug/device/biologic clinical trial during the study period;
  15. Intracardiac thrombus, drug or alcohol addiction, unwillingness or inability to complete follow-up;
  16. Severe renal insufficiency (eGFR < 30);
  17. Previous catheter ablation for atrial fibrillation;
  18. Primary severe sick sinus syndrome.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pulsed Field Ablation with a catheter for Pulmonary Vein Isolation
Device: Pulsed Field Ablation - pulmonary vein isolation
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.
Experimental: Pulsed Field Ablation with a catheter for Pulmonary Vein Isolation plus Superior Vena Cava Isolation
Device: Pulsed Field Ablation - Pulmonary Vein Isolation + Superior Vena Cava Isolation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment success from 3 months after the ablation (after the blanking period) through the 12-month follow-up
Time Frame: 3 months after the ablation (after the blanking period) through the 12-month follow-up
3 months after the ablation (after the blanking period) through the 12-month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) during the 3-month blanking period after the index ablation
Time Frame: From the index ablation through 3 months after the index ablation
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)
Time Frame: From the index ablation through 12 months after the index ablation
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)
Time Frame: From baseline through 12 months after the index ablation
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
Time Frame: From baseline through 12 months after the index ablation
From baseline through 12 months after the index ablation
Incidence of cardiovascular-related rehospitalization
Time Frame: From the index ablation through 12 months after the index ablation
From the index ablation through 12 months after the index ablation
Proportion of participants undergoing repeat catheter ablation
Time Frame: From the index ablation through 12 months after the index ablation
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
Time Frame: From the index ablation through 30 days after the index ablation
From the index ablation through 30 days after the index ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

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 (Estimated)

October 8, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

September 8, 2026

First Submitted That Met QC Criteria

September 8, 2026

First Posted (Actual)

September 14, 2026

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 8, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PULSED-SVC Trial

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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.

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