A Study on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for Paroxysmal Atrial Fibrillation
440
about 2 years
18–80
43 sites in AZ, CA, CO +17
What this study is about
Researchers are testing the safety and effectiveness of a device called OMNYPULSE™ to treat paroxysmal atrial fibrillation (PAF), an irregular heart rate. The trial will last 732 days and involve approximately 440 participants.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Use OMNYPULSE™ Catheter with the TRUPULSE Generator
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Number of Participants with Primary Adverse Events (PAEs)
Secondary: Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
therapeutic, implantable
Cardiology / Heart