Trials / Completed
CompletedNCT01700439
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
Multi-CenTer Experience With the Rapid Deployment EDWARDS INTUITY Valve System FOR Aortic Valve ReplaceMent
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 934 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.
Detailed description
This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be enrolled at up to 35 centers in the US. After replacement of their aortic heart valve with the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the following intervals: discharge, 3 months, 1 year, and annually thereafter for a minimum of five years.
Conditions
- Aortic Valve Stenosis
- Aortic Valve Stenosis With Insufficiency
- Regurgitation, Aortic Valve
- Aortic Valve Incompetence
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EDWARDS INTUITY valve | Surgical replacement of the aortic valve with the EDWARDS INTUITY valve. |
Timeline
- Start date
- 2012-09-26
- Primary completion
- 2021-05-26
- Completion
- 2021-05-26
- First posted
- 2012-10-04
- Last updated
- 2023-05-19
- Results posted
- 2017-12-13
Locations
29 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01700439. Inclusion in this directory is not an endorsement.