Trials / Completed
CompletedNCT02359890
SMART-SF Radiofrequency Ablation Safety Study
Prospective Safety Assessment of the THERMOCOOL® SMARTTOUCH® SF Family of Contact Force Sensing Catheters for the Radiofrequency Ablation Treatment of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 165 (actual)
- Sponsor
- Biosense Webster, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation (SMART-SF).
Detailed description
The purpose of this study is to demonstrate the safety of the study device in the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (PAF) during standard electrophysiology mapping and RF ablation procedures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | THERMOCOOL® SMARTTOUCH® (RF ablation treatment) | Radiofrequency Ablation Treatment |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2015-09-01
- Completion
- 2016-11-08
- First posted
- 2015-02-10
- Last updated
- 2025-02-04
- Results posted
- 2017-10-17
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02359890. Inclusion in this directory is not an endorsement.