Trials / Completed
CompletedNCT02485925
SMART China, A Multi-center Clinical Registry Study
The Effectiveness and Safety in the Treatment of Circumferential Pulmonary Vein Isolation (CPVI) for Symptomatic Paroxysmal Atrial Fibrillation With THERMOCOOL® SMARTTOUCH™ Catheter in China, A Multi-center Clinical Registry Study
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- Biosense Webster, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective effectiveness and safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation.
Detailed description
The purpose of this study is to assess the effectiveness and safety of the THERMOCOOL® SMARTTOUCH™ catheter in the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (PAF) undergoing CPVI.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | THERMOCOOL® SMARTTOUCH™ | Pulmonary vein isolation by RF ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device) |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2017-06-30
- Completion
- 2017-06-30
- First posted
- 2015-06-30
- Last updated
- 2025-02-04
- Results posted
- 2018-07-31
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02485925. Inclusion in this directory is not an endorsement.