Trials / Completed
CompletedNCT03056573
Assessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Expand the indication of the Portico TF Delivery System and obtain approval of the Alternative Access Delivery System
Detailed description
Expand the indication of the Portico TF Delivery System and obtain approval of the Alternative Access Delivery System to place a Portico transcatheter aortic valve through an alternative access site, specifically subclavian/axillary or transaortic (TAo) in subjects with symptomatic severe native aortic stenosis who are considered high surgical risk
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transaortic TAVR Implant | Transaortic TAVR implant |
| DEVICE | Subclavian /Axillary TAVR implant | Subclavian /Axillary TAVR implant |
Timeline
- Start date
- 2017-03-29
- Primary completion
- 2018-12-31
- Completion
- 2019-07-05
- First posted
- 2017-02-17
- Last updated
- 2025-02-11
- Results posted
- 2020-03-17
Locations
10 sites across 5 countries: Denmark, Germany, Italy, Netherlands, Switzerland
Source: ClinicalTrials.gov record NCT03056573. Inclusion in this directory is not an endorsement.