This study wants to measure the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).
Official registry: https://clinicaltrials.gov/study/NCT07227532 · Biosense Webster, Inc. · enrollment listed as 276
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 Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator. The registry lists allocation as na. This study wants to measure the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).
They plan to enroll about 276 people at 25 sites. Taking part typically means using or being fitted with a device plus check-ins.
BWI202405: Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System
Interventions: Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator
Primary outcome (registry wording): Occurences of Early Onset Primary Adverse Events (PAEs) Within 7 days of the Index Ablation Procedure
Emily Purcell
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
This is a single-center prospective watch-and-measure (no experimental treatment required) cohort study of atrial fibrillation patients treated with radiofrequency ablation.
NCT05266144 · Official ClinicalTrials.gov record · Peking Union Medical College Hospital
Background: Bruton s tyrosine kinase inhibitors (BTKi) are used to treat a form of leukemia. But taking BTKi can also increase a person s risk of developing an abnormal heart rhythm.
NCT05724121 · Official ClinicalTrials.gov record · National Heart, Lung, and Blood Institute (NHLBI)
REACT-AF is a multicenter prospective, randomly assigned, open-label, blinded endpoint (PROBE design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk.
NCT05836987 · Official ClinicalTrials.gov record · Johns Hopkins University
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.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary