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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Venus MedTech (HangZhou) Inc.
Sponsor:
Information provided by (Responsible Party):
Venus MedTech (HangZhou) Inc.
ClinicalTrials.gov Identifier:
NCT01683474
First received: September 7, 2012
Last updated: December 21, 2013
Last verified: December 2013
  Purpose
  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.

Condition Intervention
Native Aortic Valve Disease
Aortic Valve Stenosis
Aortic Valve Calcification
Device: Venus MedTech Aortic Valve Prosthesis

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Venus MedTech (HangZhou) Inc.:

Primary Outcome Measures:
  • All cause mortality and major stroke at 12 months post-procedure. [ Time Frame: 12 months post-procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Valve performance and placement at 6 and 12 months post-procedure [ Time Frame: 6 and 12 months post-procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Venus A-Valve
single arm with intervention that percutaneous implantation of the Venus MedTech Aortic Valve Prosthesis
Device: Venus MedTech Aortic Valve Prosthesis
Other Names:
  • Venus A-Valve
  • Venus A-Valve System

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683474

Contacts
Contact: Runlin Gao, MD 88398866 ext 8266 gaorunlin4study@gmail.com

Locations
China, Beijing
Fu Wai Hospital, CAMS & PUMA Recruiting
Beijing, Beijing, China, 100037
Contact: Runlin Gao, MD       gaorunlin4study@gmail.com   
Principal Investigator: Runlin Gao, MD         
Sponsors and Collaborators
Venus MedTech (HangZhou) Inc.
  More Information

No publications provided

Responsible Party: Venus MedTech (HangZhou) Inc.
ClinicalTrials.gov Identifier: NCT01683474     History of Changes
Other Study ID Numbers: Venus-A Study
Study First Received: September 7, 2012
Last Updated: December 21, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Venus MedTech (HangZhou) Inc.:
aortic valve stenosis
Calcification
TAVI
aortic valve Prosthesis

Additional relevant MeSH terms:
Aortic Valve Stenosis
Calcinosis
Heart Defects, Congenital
Heart Valve Diseases
Calcium Metabolism Disorders
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Diseases
Metabolic Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on October 30, 2014