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

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ClinicalTrials.gov Identifier: NCT02536703
Recruitment Status : Not yet recruiting
First Posted : September 1, 2015
Last Update Posted : September 1, 2015
Sponsor:
Information provided by (Responsible Party):
Jian'an Wang,MD,PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: Lotus Valve System Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LOTUS-CHINA: Safety and Efficacy of Lotus Valve For Transcatheter Aortic Valve Implantation In Patients With Severe Aortic Stenosis In Chinese Population
Study Start Date : September 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Number of participants with procedural complications [ Time Frame: 30 days following procedure ]
  2. Functional status (NYHA-classification) [ Time Frame: 6 months following procedure ]
  3. Echocardiographic prosthesis status [ Time Frame: 6 months following procedure ]
  4. Quality of Life (SF-12) [ Time Frame: 6 months following procedure ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT02536703


Contacts
Contact: Xianbao Liu, MD +86-13857173887 liuxb2009@hotmail.com
Contact: Jian-an Wang, MD,PhD +86-13805786328 Wang_jian_an@tom.com

Locations
China, Zhejiang
2nd Affiliated Hospital, School of Medicine at Zhejiang University Not yet recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Xianbao Liu, MD    +86-13857173887    liuxb2009@hotmail.com   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
Principal Investigator: Jian-an Wang, MD,PhD Second Affiliated Hospital Zhejiang University School of Medicine

Responsible Party: Jian'an Wang,MD,PhD, President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT02536703     History of Changes
Other Study ID Numbers: SAHZJU CT005
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction