Trials / Completed
CompletedNCT01639495
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation Continued Access
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 148 (actual)
- Sponsor
- Biosense Webster, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.
Detailed description
The device is currently under investigation with IDE #G110030. This continued access study will enroll subjects that have participated in the Smart-AF IDE study. Subjects with drug refractory symptomatic paroxysmal atrial fibrillation (PAF) will be considered for this study. Effectiveness and safety endpoints have been defined and will be evaluated post treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | THERMOCOOL® SMARTTOUCH™ Catheter | AF Ablation |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2014-06-01
- Completion
- 2014-10-01
- First posted
- 2012-07-12
- Last updated
- 2018-05-15
- Results posted
- 2018-05-15
Locations
20 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01639495. Inclusion in this directory is not an endorsement.