Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population

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Brief Title

Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population

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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Combined rate of death from any cause, myocardial infarction, and stroke

Secondary Outcome

 Number of participants with procedural complications

Condition

Aortic Valve Stenosis

Intervention

Lotus Valve System

Study Arms / Comparison Groups

 Lotus Valve System
Description:  Transcatheter Aortic Valve Implantation (TAVI) with Lotus Valve System

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

20

Start Date

September 2015

Completion Date

December 2020

Primary Completion Date

December 2015

Eligibility Criteria

        Inclusion Criteria:

          1. Patients with symptomatic severe aortic stenosis (echocardiographic criteria: AV
             effective orifice area (EOA) of < 1 cm2, mean AV gradient of > 40 mmHg, or AV peak
             systolic velocity of > 4.0 m/s; NYHA-class II or greater, angina pectoris, or syncope)

          2. Subject has been informed of the nature of the study, agrees to its provisions and has
             provided written informed consent.

          3. The subject agrees to comply with specified follow-up evaluations and to return to the
             investigational site where the procedure was performed.

          4. Patients are technical and anatomical eligible for interventions

        Exclusion Criteria:

          1. A known hypersensitivity or contraindication to any of the following which cannot be
             adequately pre-medicated:

             Aspirin Heparin (HIT/HITTS) and bivalirudin Nitinol (titanium or nickel) Ticlopidine
             and clopidogrel Contrast media

          2. Subject refuses a blood transfusion.

          3. Other medical, social, or psychological conditions that in the opinion of an
             Investigator precludes the subject from appropriate consent.

          4. Native aortic annulus size < 20 mm or > 29 mm per the baseline diagnostic imaging.

          5. Life expectancy is less than one year

Gender

All

Ages

65 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jian-an Wang, MD,PhD, +86-13857173887, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT02536703

Organization ID

SAHZJU CT005

Responsible Party

Principal Investigator

Study Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Sponsor

Jian-an Wang, MD,PhD, Principal Investigator, Second Affiliated Hospital Zhejiang University School of Medicine

Verification Date

August 2015