Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis (Venus-A)

January 3, 2015 updated by: Venus MedTech (HangZhou) Inc.

Clinical Evaluation of the Safety and Performance of Percutaneous Implantation of the Venus MedTech Aortic Valve Prosthesis for Patients Who Cannot Undergo Surgical Valve Replacement

  1. objectives

    • Evaluate the performance of Venus MedTech aortic valve prosthesis intervention by femoral artery
    • Evaluate safety and clinical benefit of percutaneous implantation of the Venue MedTech aortic valve prosthesis.
    • Continuous observe 12 months of safety and efficacy.
  2. Approximately 80 patients presenting with native aortic valve stenosis necessitating valve replacement which are considered unsuitable for Surgical Valve Replacement, with a high surgical risk, as attested to by both the surgeon and the cardiologist are recruited in the study.
  3. Safety and performance will be evaluated at discharge and at 30 days post procedure. Valve safety, performance and placement will be followed up at 6 and 12 months post-procedure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A prospective OPC study to evaluate its performance and long-term safety and effectiveness of Venus-A aortic valve.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Fu Wai Hospital, CAMS & PUMA
        • Contact:
        • Principal Investigator:
          • Runlin Gao, MD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient ≥ 40 mm Hg, or jet velocity ≥ 4.0 m/s, or an aortic valve area (AVA) of < 0.8 cm2 (or AVA index < 0.5 cm2/m2)
  • Symptomatic due to aortic valve stenosis as demonstrated by NYHA Functional Class ≥ II
  • The subject or the subject's legal representative was informed of the nature of the study, agreed to its provisions and provided written informed consent as approved by the Institutional Review Board of the respective clinical site.
  • The subject agreed to comply follow-up evaluation
  • is evaluated by at least one cardiologist and two cardiovascular surgeon, and they agreed that medical factors precluding operation suitable for surgery (the probability of death or serious, irreversible morbidity exceeded 50%)
  • STS score ≥ 10%

Exclusion Criteria:

  • Patient refuses aortic valve replacement surgery.
  • Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
  • Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
  • Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
  • Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days （6 month if DES implant）
  • Implanted any heart valve prosthesis, prosthetic valve ring, severe mitral valve ring calcification (MAC), severe（>3＋）mitral valve insufficiency, or Gorelin symptom
  • Blood dyscrasia such as leukopenia (WBC < 3×109/L), acute anemia (Hgb < 90 g/L), thrombocytopenia (PLT < 50×109/L), bleeding diathesis, or history of coagulopathy.
  • Untreated clinically significant coronary artery disease requiring revascularization
  • Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices
  • Need for emergency surgery for any reason
  • Hypertrophic cardiomyopathy with or without obstruction (HOCM)
  • Severe ventricular dysfunction with LVEF < 20%
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation
  • Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months
  • A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, Nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated.
  • Native aortic annulus size < 20 mm or> 29 mm as measured by echocardiogram.
  • Cerebrovascular Accident (CVA) within 6 months, including TIA.
  • Renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring chronic dialysis.
  • Life expectancy < 12 months
  • Significant abdominal or thoracic aorta disease, including aneurysm (defined as maximal luminal diameter 5cm or greater), marked tortuosity (hyperacute bend), aortic arch atheroma (especially if thick [> 5 mm], protruding or ulcerated), narrowing of the abdominal aorta (especially with calcification and surface irregularities), or severe "unfolding" and tortuosity of the thoracic aorta
  • Iliofemoral vessel characteristics that would preclude safe placement of 16F or 18F introducer sheath such as severe obstructive calcification, severe tortuosity or vessel size diameter < 7 mm.
  • Currently participating in an investigational drug or another device study.
  • Active bacterial endocarditis or other active infections.
  • Bulky calcified aortic valve leaflets in close proximity to coronary ostia

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Venus A-Valve
single arm with intervention that percutaneous implantation of the Venus MedTech Aortic Valve Prosthesis
Device: Venus MedTech Aortic Valve Prosthesis
Percutaneous implantation of aortic valve of Venus-A
Other Names:
  • Venus A-Valve
  • Venus A-Valve System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality and major stroke at 12 months post-procedure.
Time Frame: 12 months post-procedure
12 months post-procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Valve performance and placement at 6 and 12 months post-procedure
Time Frame: 6 and 12 months post-procedure
6 and 12 months post-procedure

Collaborators and Investigators

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

Sponsor

Venus MedTech (HangZhou) Inc.

Investigators

  • Principal Investigator: Ruilin Gao, MD, Fuwai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2012

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

September 7, 2012

First Submitted That Met QC Criteria

September 7, 2012

First Posted (Estimate)

September 11, 2012

Study Record Updates

Last Update Posted (Estimate)

January 6, 2015

Last Update Submitted That Met QC Criteria

January 3, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Venus-A Study

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.

Clinical Trials on Aortic Valve Stenosis

Clinical Trials on Venus MedTech Aortic Valve Prosthesis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe