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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

8 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

340

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Pulsed Field Ablation with a catheter for Pulmonary Vein Isolation
Enhet: 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.
Experimentell: Pulsed Field Ablation with a catheter for Pulmonary Vein Isolation plus Superior Vena Cava Isolation
Enhet: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Treatment success from 3 months after the ablation (after the blanking period) through the 12-month follow-up
Tidsram: 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

Sekundära resultatmått

Resultatmått
Tidsram
Incidence of atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) during the 3-month blanking period after the index ablation
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: From baseline through 12 months after the index ablation
From baseline through 12 months after the index ablation
Incidence of cardiovascular-related rehospitalization
Tidsram: 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
Tidsram: 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
Tidsram: From the index ablation through 30 days after the index ablation
From the index ablation through 30 days after the index ablation

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Ruijin Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

8 oktober 2026

Primärt slutförande (Beräknad)

1 oktober 2028

Avslutad studie (Beräknad)

1 oktober 2028

Studieregistreringsdatum

Först inskickad

8 september 2026

Först inskickad som uppfyllde QC-kriterierna

8 september 2026

Första postat (Faktisk)

14 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

14 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • PULSED-SVC Trial

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Ja

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