Trials / Completed
CompletedNCT03683030
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 397 (actual)
- Sponsor
- Biosense Webster, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation.
Detailed description
The STELLAR study is a pivotal, prospective, multicenter, single-arm, clinical evaluation of the Multi-Electrode RF Balloon catheter. The study will evaluate the safety and effectiveness of the Multi-Electrode RF Balloon catheter used for ablation in patients with paroxysmal atrial fibrillation (PAF).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Multi-Electrode RF Balloon Catheter | Multi-Electrode RF Balloon Catheter will be inserted |
Timeline
- Start date
- 2018-10-22
- Primary completion
- 2022-02-18
- Completion
- 2022-02-18
- First posted
- 2018-09-25
- Last updated
- 2025-10-20
- Results posted
- 2025-08-15
Locations
41 sites across 3 countries: United States, China, Italy
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03683030. Inclusion in this directory is not an endorsement.