Trials / Completed
CompletedNCT03437733
Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 98 (actual)
- Sponsor
- Biosense Webster, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This clinical investigation is a prospective, multicenter, single arm clinical evaluation utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode circular diagnostic catheter.
Detailed description
The objective of this clinical investigation is to assess the safety and acute effectiveness of the multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter when used for the isolation of the pulmonary veins in the treatment of Paroxysmal Atrial Fibrillation (PAF).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Radiofrequency Ablation | RF ablation using multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter |
Timeline
- Start date
- 2018-02-28
- Primary completion
- 2019-02-01
- Completion
- 2019-10-17
- First posted
- 2018-02-19
- Last updated
- 2025-06-29
- Results posted
- 2020-02-10
Locations
5 sites across 3 countries: Czechia, Italy, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03437733. Inclusion in this directory is not an endorsement.