Clinical trials: Critical Aortic Stenosis
Severe Aortic Stenosis
Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted very high risk and high risk for aortic…
- Trial name
- NCT01531374
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 45 sites in United States
- Volunteers
- 2,777 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Stenosis, Heart Valve Diseases
JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study
To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT02732691
- Testing
- JenaValve Pericardial TAVR System
- Where
- 13 sites in United States, Germany and 2 more
- Volunteers
- 68 people
- Sponsor
- JenaValve Technology, Inc.
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or…
- Trial name
- NCT01240902
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR)
- Where
- 45 sites in United States
- Volunteers
- 1,453 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Stenosis
Valvuloplasty Scoring Balloon Catheter First-in-Man Study
The Valvuloplasty Scoring Balloon First-in-Man study is a prospective, single arm, two phase, observational registry to demonstrate the safety and efficacy of the Valvuloplasty Scoring Balloon Catheter for the treatment of…
- Trial name
- NCT01514994
- Testing
- AngioScore's Valvuloplasty Scoring Balloon
- Where
- Canada
- Volunteers
- 25 people
- Sponsor
- Spectranetics Corporation
Critical Aortic Stenosis
THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.
- Trial name
- PARTNER (NCT00530894)
- Testing
- Edwards SAPIEN Transcatheter Heart Valve, Surgical Valve Replacement, medical management and/or balloon aortic valvuloplasty
- Where
- 26 sites in United States, Canada and 1 more
- Volunteers
- 1,057 people
- Sponsor
- Edwards Lifesciences