Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population (LOTUS-CHINA)

August 27, 2015 updated by: Jian'an Wang,MD,PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University

LOTUS-CHINA: Safety and Efficacy of Lotus Valve For Transcatheter Aortic Valve Implantation In Patients With Severe Aortic Stenosis In Chinese Population

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • 2nd Affiliated Hospital, School of Medicine at Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lotus Valve System
Transcatheter Aortic Valve Implantation (TAVI) with Lotus Valve System
Device: Lotus Valve System
Lotus Valve System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
30 days following procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with procedural complications
Time Frame: 30 days following procedure
30 days following procedure
Functional status (NYHA-classification)
Time Frame: 6 months following procedure
6 months following procedure
Echocardiographic prosthesis status
Time Frame: 6 months following procedure
6 months following procedure
Quality of Life (SF-12)
Time Frame: 6 months following procedure
6 months following procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

August 27, 2015

First Submitted That Met QC Criteria

August 27, 2015

First Posted (Estimate)

September 1, 2015

Study Record Updates

Last Update Posted (Estimate)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 27, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHZJU CT005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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