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
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Tianyou Ling
- Numéro de téléphone: +8618930235117
- E-mail: lty11498@rjh.com.cn
Lieux d'étude
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Chine
- Ruijin Hostpial Shanghai Jiaotong University School of Medicine
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Pulsed Field Ablation with a catheter for 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.
|
|
Expérimental: Pulsed Field Ablation with a catheter for Pulmonary Vein Isolation plus 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Treatment success from 3 months after the ablation (after the blanking period) through the 12-month follow-up
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Incidence of atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) during the 3-month blanking period after the index ablation
Délai: 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)
Délai: 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)
Délai: 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
Délai: From baseline through 12 months after the index ablation
|
From baseline through 12 months after the index ablation
|
|
Incidence of cardiovascular-related rehospitalization
Délai: 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
Délai: 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
Délai: From the index ablation through 30 days after the index ablation
|
From the index ablation through 30 days after the index ablation
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PULSED-SVC Trial
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .