Efficacy and Safety of Superior Vena Cava Isolation and Pulmonary Vein Isolation for Treatment of Atrial Fibrillation (SAVE-AF)
23. juli 2026 oppdatert av: Qiang Hu
Efficacy and Safety of Superior Vena Cava Isolation in Addition to Pulmonary Vein Isolation by Pulsed Field Ablation for Treatment of Atrial Fibrillation
Atrial fibrillation (AF) is one of the most concerning diseases in the field of cardiac arrhythmias.
It is a type of rapid supraventricular arrhythmia characterized by rapid and disorganized contraction of the atria, which leads to ventricular rate disturbance, impaired cardiac function, and an increased risk of atrial mural thrombus formation.
AF severely reduces patients' quality of life and can cause complications such as heart failure, stroke, and sudden death.
Currently, the vast majority of AF episodes are triggered by pulmonary vein (PV) ectopic foci.
Therefore, catheter ablation is the preferred treatment strategy, with pulmonary vein isolation (PVI) being the cornerstone procedure.
However, a small proportion of patients may have non-PV triggers, particularly originating from the superior vena cava (SVC).
Conventional radiofrequency ablation (RFA) for SVC isolation carries unpredictable risks, including damage to the sinus node and the phrenic nerve.
Therefore, this study aims to investigate the impact of empirical SVC electrical isolation in addition to PVI on the success rate of AF ablation, using pulsed field ablation (PFA)-a non-thermal ablation modality with tissue selectivity and a favorable safety profile.
Studieoversikt
Status
Rekruttering
Forhold
Studietype
Intervensjonell
Registrering (Antatt)
200
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Qiang Hu, Doctor
- Telefonnummer: +8602886590223
- E-post: huqiang071@foxmail.com
Studiesteder
-
-
Sichuan
-
Chengdu, Sichuan, Kina, 610000
- Rekruttering
- Qiang Hu
-
Ta kontakt med:
- Qiang Hu, Doctor
- Telefonnummer: +8602886590223
- E-post: huqiang071@foxmail.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 years;
- Patients with documented atrial fibrillation (AF), confirmed by at least one episode of AF recorded on a 12-lead surface electrocardiogram (ECG) or ambulatory ECG monitoring within the past 12 months;
- Subjects who agree to undergo treatment for AF using a pulsed field ablation (PFA) system that is currently commercially available in China;
- Patients who have shown an inadequate response to, or intolerance of, at least one class of antiarrhythmic drug therapy;
- Subjects or their legally authorized representatives who have been informed of the nature of this study, have agreed to all terms and conditions of the study, and have provided written informed consent, and who are willing to complete all required clinical follow-up visits in accordance with the study protocol.
Exclusion Criteria:
- Prior surgical or catheter ablation for any type of cardiac arrhythmia;
- AF secondary to electrolyte imbalance, valvular heart disease, thyroid disease, or other reversible causes;
- Known requirement for ablation outside the pulmonary vein ostia or beyond the cavotricuspid isthmus;
- Sinus node dysfunction or other indications for permanent pacemaker implantation;
- Myocardial infarction, or prior coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the past 6 months;
- Left atrial anteroposterior diameter ≥ 50 mm;
- Evidence of left atrial or left atrial appendage thrombus confirmed by transesophageal echocardiography (TEE) or left atrial computed tomography (CT) within 24 hours prior to the procedure;
- Serum creatinine > 2 times the upper limit of normal, or currently on dialysis;
- History of prior cardiothoracic surgery;
- History of permanent pacemaker implantation;
- History of malignancy;
- Long-term use of a central venous catheter;
- Contraindications to anticoagulation therapy (including allergy to anticoagulants, thrombocytopenia, severe bleeding tendency, or coagulation disorders);
- History of allergy to contrast;
- Women who are pregnant, lactating, or who are unwilling to use adequate contraception during the study period;
- Subjects or their legally authorized representatives who are unwilling to provide written informed consent;
- Subjects who, for any reason, are unable to comply with the study protocol or complete all required clinical follow-up visits;
- Subjects deemed by the investigator to be unsuitable for PFA treatment of AF.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: superior vena cava isolation plus pulmonary vein isolation
|
Eligible patients with atrial fibrillation who are randomized to the experimental group will undergo superior vena cava (SVC) electrical isolation in addition to pulmonary vein isolation (PVI) during the pulsed field ablation procedure
|
|
Aktiv komparator: pulmonary vein isolation
|
Eligible patients with atrial fibrillation who are randomized to the control group will undergo pulmonary vein isolation (PVI) during the pulsed field ablation procedure
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
the success rate of atrial fibrillation ablation
Tidsramme: at 3 month
|
it is assessed by 7-day Holter monitoring
|
at 3 month
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
the success rate of atrial fibrillation ablation
Tidsramme: at 6 month and 12 month
|
it is assessed by 7-day Holter monitoring
|
at 6 month and 12 month
|
|
left ventricular end-systolic diameter
Tidsramme: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left ventricular end-diastolic diameter
Tidsramme: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left ventricular posterior wall thickness
Tidsramme: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
interventricular septal thickness
Tidsramme: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left ventricular ejection fraction
Tidsramme: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
E/A
Tidsramme: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
E/e'
Tidsramme: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left atrial volume index
Tidsramme: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left atrial anteroposterior diameter
Tidsramme: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left atrial strain
Tidsramme: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
New York Heart Association class
Tidsramme: at 3 month, 6 month and 12 month
|
The NYHA is measured by Classification of NYHA heart function
|
at 3 month, 6 month and 12 month
|
|
Major adverse events
Tidsramme: at 3 month, 6 month and 12 month
|
Major adverse events is a composite endpoint of death, stroke, and myocardial infarction.
|
at 3 month, 6 month and 12 month
|
|
6-min walk distance
Tidsramme: at 3 month, 6 month and 12 month
|
During the test, patients were asked to walk for 6 minutes on a long corridor with a length of 37.5 meters between the 2 marks
|
at 3 month, 6 month and 12 month
|
|
red blood cell count
Tidsramme: at 3 month, 6 month and 12 month
|
It is obtained from the routine blood test.
|
at 3 month, 6 month and 12 month
|
|
hemoglobin
Tidsramme: at 3 month, 6 month and 12 month
|
It is obtained from the routine blood test.
|
at 3 month, 6 month and 12 month
|
|
white blood cell count
Tidsramme: at 3 month, 6 month and 12 month
|
It is obtained from the routine blood test.
|
at 3 month, 6 month and 12 month
|
|
platelet count
Tidsramme: at 3 month, 6 month and 12 month
|
It is obtained from the routine blood test.
|
at 3 month, 6 month and 12 month
|
|
alanine aminotransferase
Tidsramme: at 3 month, 6 month and 12 month
|
It is obtained from the liver function test.
|
at 3 month, 6 month and 12 month
|
|
aspartate aminotransferase
Tidsramme: at 3 month, 6 month and 12 month
|
It is obtained from the liver function test.
|
at 3 month, 6 month and 12 month
|
|
creatinine
Tidsramme: at 3 month, 6 month and 12 month
|
It is obtained from the renal function test
|
at 3 month, 6 month and 12 month
|
|
urea
Tidsramme: at 3 month, 6 month and 12 month
|
It is obtained from the renal function test
|
at 3 month, 6 month and 12 month
|
|
estimated glomerular filtration rate
Tidsramme: at 3 month, 6 month and 12 month
|
It is obtained from the renal function test
|
at 3 month, 6 month and 12 month
|
|
activated partial thromboplastin time
Tidsramme: at 3 month, 6 month and 12 month
|
It is obtained from the coagulation function test
|
at 3 month, 6 month and 12 month
|
|
prothrombin time
Tidsramme: at 3 month, 6 month and 12 month
|
It is obtained from the coagulation function test
|
at 3 month, 6 month and 12 month
|
|
international normalized ratio
Tidsramme: at 3 month, 6 month and 12 month
|
It is obtained from the coagulation function test
|
at 3 month, 6 month and 12 month
|
|
B-type natriuretic peptide
Tidsramme: at 3 month, 6 month and 12 month
|
It is obtained from a blood sample.
|
at 3 month, 6 month and 12 month
|
|
Atrial Fibrillation Effect on Quality of Life Questionnaire
Tidsramme: at 3 month, 6 month and 12 month
|
AFEQT questionnaire was used to assess the quality of life of patients with atrial fibrillation.
|
at 3 month, 6 month and 12 month
|
|
readmission
Tidsramme: at 3 month, 6 month and 12 month
|
Rehospitalization was indicated for atrial fibrillation.
|
at 3 month, 6 month and 12 month
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. juli 2026
Primær fullføring (Antatt)
31. mars 2029
Studiet fullført (Antatt)
31. mars 2029
Datoer for studieregistrering
Først innsendt
21. juli 2026
Først innsendt som oppfylte QC-kriteriene
21. juli 2026
Først lagt ut (Faktiske)
24. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- N2026-07
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .