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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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

340

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Pulsed Field Ablation with a catheter for Pulmonary Vein Isolation
Apparaat: 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.
Experimenteel: Pulsed Field Ablation with a catheter for Pulmonary Vein Isolation plus Superior Vena Cava Isolation
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ruijin Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

8 oktober 2026

Primaire voltooiing (Geschat)

1 oktober 2028

Studie voltooiing (Geschat)

1 oktober 2028

Studieregistratiedata

Eerst ingediend

8 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 september 2026

Eerst geplaatst (Werkelijk)

14 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 september 2026

Laatste update ingediend die voldeed aan QC-criteria

8 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • PULSED-SVC Trial

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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