Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis

NCT01683474 | Unknown DMC

• 1 other identifier: Venus-A Study
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.
• 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.
• 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.

Conditions

Aortic Valve Stenosis; Aortic Valve Calcification

Keywords

aortic valve stenosis; Calcification; TAVI; aortic valve Prosthesis

Outcome Measures

Primary Outcomes (1)

• All cause mortality and major stroke at 12 months post-procedure.

  12 months post-procedure

Secondary Outcomes (1)

• Valve performance and placement at 6 and 12 months post-procedure

  6 and 12 months post-procedure

Study Arms (1)

Venus A-Valve

EXPERIMENTAL

single arm with intervention that percutaneous implantation of the Venus MedTech Aortic Valve Prosthesis

Device: Venus MedTech Aortic Valve Prosthesis

Interventions

Venus MedTech Aortic Valve Prosthesis DEVICE

Percutaneous implantation of aortic valve of Venus-A

Also known as: Venus A-Valve, Venus A-Valve System

Venus A-Valve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Venus MedTech (HangZhou) Inc.: lead

Study Sites (1)

Fu Wai Hospital, CAMS & PUMA

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (3)

• Lei WH, Liao YB, Wang ZJ, Ou YW, Tsauo JY, Li YJ, Xiong TY, Zhao ZG, Wei X, Meng W, Feng Y, Chen M. Transcatheter Aortic Valve Replacement in Patients with Aortic Stenosis Having Coronary Cusp Fusion versus Mixed Cusp Fusion Nonraphe Bicuspid Aortic Valve. J Interv Cardiol. 2019 Nov 3;2019:7348964. doi: 10.1155/2019/7348964. eCollection 2019.

  PMID: 31777470 DERIVED

• Liao YB, Li YJ, Xiong TY, Ou YW, Lv WY, He JL, Li YM, Zhao ZG, Wei X, Xu YN, Feng Y, Chen M. Comparison of procedural, clinical and valve performance results of transcatheter aortic valve replacement in patients with bicuspid versus tricuspid aortic stenosis. Int J Cardiol. 2018 Mar 1;254:69-74. doi: 10.1016/j.ijcard.2017.12.013. Epub 2017 Dec 9.

  PMID: 29246428 DERIVED

• Jilaihawi H, Wu Y, Yang Y, Xu L, Chen M, Wang J, Kong X, Zhang R, Wang M, Lv B, Wang W, Xu B, Makkar RR, Sievert H, Gao R. Morphological characteristics of severe aortic stenosis in China: imaging corelab observations from the first Chinese transcatheter aortic valve trial. Catheter Cardiovasc Interv. 2015 Mar;85 Suppl 1:752-61. doi: 10.1002/ccd.25863. Epub 2015 Feb 19.

  PMID: 25630494 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve, Calcification of; Calcinosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ruilin Gao, MD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Runlin Gao, MD

CONTACT

88398866; gaorunlin4study@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: September 11, 2012
• Study Start: September 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: April 1, 2016
• Last Updated: January 6, 2015

Record last verified: 2015-01

Locations

CN (1)