This prospective, multicenter, randomly assigned, controlled, noninferiority trial will compare local anesthesia with conscious sedation and general anesthesia in patients undergoing pulsed field ablation for paroxysmal atrial fibrillation. A total of 390 participants aged 18 to 80 years will be randomly assigned in a 1:1 ratio to undergo pulsed field ablation under either local anesthesia with conscious sedation or general anesthesia.
Official registry: https://clinicaltrials.gov/study/NCT07877519 · China National Center for Cardiovascular Diseases · enrollment listed as 390
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are Local Anesthesia With Conscious Sedation, General Anesthesia, or VARIPULSE Pulsed Field Ablation System. The registry lists allocation as randomized. This prospective, multicenter, randomly assigned, controlled, noninferiority trial will compare local anesthesia with conscious sedation and general anesthesia in patients undergoing pulsed field ablation for paroxysmal atrial fibrillation.
They plan to enroll about 390 people at Beijing. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device, a procedure as part of the study plus check-ins.
Efficacy and Safety of Local Anesthesia With Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Patients With Paroxysmal Atrial Fibrillation: A Prospective, Multicenter, Randomized, Controlled, Noninferiority Trial
Interventions: Local Anesthesia With Conscious Sedation, General Anesthesia, VARIPULSE Pulsed Field Ablation System, Compound methoxyphenamine capsules, Salbutamol, Budesonide, Lidocaine, Fentanyl, Midazolam, Tropisetron hydrochloride, Dexamethasone, Atropine
Primary outcome (registry wording): Percentage of Participants With Recurrence of Atrial Tachyarrhythmia After the Blanking Period
Guanzhi Chen, Doctor
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
We will investigate the clinical manifestations and molecular genetic defects of heritable urologic malignant disorders. Families with urologic malignancy with known or suspected genetic basis will be enrolled.
NCT00001238 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)
This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.
NCT00001372 · Official ClinicalTrials.gov record · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases. The following individuals may be eligible for this natural history study: 1) patients with known or suspected familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 7 years of age or older.
NCT00001373 · Official ClinicalTrials.gov record · National Human Genome Research Institute (NHGRI)
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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