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 ]

Outcome measures will be defined as suggested by the Valvular Academic Research Consortium (VARC)


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