Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis (Venus-A)
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|ClinicalTrials.gov Identifier: NCT01683474|
Recruitment Status : Unknown
Verified January 2015 by Venus MedTech (HangZhou) Inc..
Recruitment status was: Recruiting
First Posted : September 11, 2012
Last Update Posted : January 6, 2015
- Evaluate the performance of Venus MedTech aortic valve prosthesis intervention by femoral artery
- Evaluate safety and clinical benefit of percutaneous implantation of the Venue MedTech aortic valve prosthesis.
- Continuous observe 12 months of safety and efficacy.
- Approximately 80 patients presenting with native aortic valve stenosis necessitating valve replacement which are considered unsuitable for Surgical Valve Replacement, with a high surgical risk, as attested to by both the surgeon and the cardiologist are recruited in the study.
- Safety and performance will be evaluated at discharge and at 30 days post procedure. Valve safety, performance and placement will be followed up at 6 and 12 months post-procedure.
|Condition or disease||Intervention/treatment||Phase|
|Aortic Valve Stenosis Aortic Valve Calcification||Device: Venus MedTech Aortic Valve Prosthesis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of the Safety and Performance of Percutaneous Implantation of the Venus MedTech Aortic Valve Prosthesis for Patients Who Cannot Undergo Surgical Valve Replacement|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||April 2016|
Experimental: Venus A-Valve
single arm with intervention that percutaneous implantation of the Venus MedTech Aortic Valve Prosthesis
Device: Venus MedTech Aortic Valve Prosthesis
Percutaneous implantation of aortic valve of Venus-A
- All cause mortality and major stroke at 12 months post-procedure. [ Time Frame: 12 months post-procedure ]
- Valve performance and placement at 6 and 12 months post-procedure [ Time Frame: 6 and 12 months post-procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683474
|Contact: Runlin Gao, MD||88398866 ext email@example.com|
|Fu Wai Hospital, CAMS & PUMA||Recruiting|
|Beijing, Beijing, China, 100037|
|Contact: Runlin Gao, MD firstname.lastname@example.org|
|Principal Investigator: Runlin Gao, MD|
|Principal Investigator:||Ruilin Gao, MD||Fuwai Hospital|