Trials / Completed
CompletedNCT04580914
Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 321 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The NEwTON AF study is a multi-center, global, prospective, single arm study to establish the safety and effectiveness of the IntellaNav StablePoint Catheter and Force-Sensing System in subjects with symptomatic, drug refractory, recurrent paroxysmal atrial fibrillation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Treatment with IntellaNav StablePoint Ablation Catheter | Patients will be treated with an ablation catheter |
Timeline
- Start date
- 2021-04-12
- Primary completion
- 2023-06-21
- Completion
- 2023-06-21
- First posted
- 2020-10-09
- Last updated
- 2025-01-16
- Results posted
- 2025-01-16
Locations
47 sites across 13 countries: United States, Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Japan, Monaco, Netherlands, Taiwan, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04580914. Inclusion in this directory is not an endorsement.