Clinical Trial: Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: LOTUS-CHINA: Safety and Efficacy of Lotus Valve For Transcatheter Aortic Valve Implantation In Patients With Severe Aortic Stenosis In Chinese Population
Brief Summary: To confirm the safety and efficacy of the Lotus™ Valve System in the Chinese population for Transcatheter Aortic Valve Implantation (TAVI) in symptomatic patients with severe aortic stenosis.
Detailed Summary:
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Current Primary Outcome: Combined rate of death from any cause, myocardial infarction, and stroke [ Time Frame: 30 days following procedure ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of participants with procedural complications [ Time Frame: 30 days following procedure ]
- Functional status (NYHA-classification) [ Time Frame: 6 months following procedure ]
- Echocardiographic prosthesis status [ Time Frame: 6 months following procedure ]
- Quality of Life (SF-12) [ Time Frame: 6 months following procedure ]
Original Secondary Outcome: Same as current
Information By: Second Affiliated Hospital, School of Medicine, Zhejiang University
Dates:
Date Received: August 27, 2015
Date Started: September 2015
Date Completion: December 2020
Last Updated: August 27, 2015
Last Verified: August 2015