Trials / Completed
CompletedNCT06272981
A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAFOUS
Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation (PAF)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 135 (actual)
- Sponsor
- Biosense Webster, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow \[STSF\] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causing abnormal blood flow.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation | THERMOCOOL STSF catheter will be used in conjunction with TRUPULSE Generator to give PF ablation or RF ablation. |
Timeline
- Start date
- 2024-02-28
- Primary completion
- 2025-10-28
- Completion
- 2025-10-28
- First posted
- 2024-02-22
- Last updated
- 2025-12-10
Locations
7 sites across 2 countries: Australia, Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06272981. Inclusion in this directory is not an endorsement.