Trials / Completed
CompletedNCT04250714
POLARx Cardiac Cryoablation System Study
POLARx Cardiac Cryoablation System Post Market Clinical Follow-up Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 400 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Post Market Clinical Follow-up (PMCF) study designed to establish the continued safety and effectiveness profile of the Boston Scientific Cardiac Cryoablation System after receiving CE mark.
Detailed description
The study will provide information on real-world usage of the Boston Scientific Cardiac Cryoablation System when used to perform pulmonary vein isolation (PVI) for the ablation treatment of atrial fibrillation (AF), according to the current and future guidelines and product indications for use. This may include but not limited to: repeated ablations to treat AF, concomitant or delayed adjunctive ablation strategies with other products and use of different diagnostic products to validate the results such as 3D mapping systems.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Boston Scientific Cardiac Cryoablation System | cryoablation of atrial fibrillation consisting in electrical isolation of the pulmonary veins |
Timeline
- Start date
- 2020-08-06
- Primary completion
- 2022-09-26
- Completion
- 2022-09-26
- First posted
- 2020-01-31
- Last updated
- 2025-04-04
- Results posted
- 2024-02-12
Locations
19 sites across 7 countries: Belgium, Croatia, France, Germany, Italy, Netherlands, United Kingdom
Source: ClinicalTrials.gov record NCT04250714. Inclusion in this directory is not an endorsement.