To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis

NCT04893603 | Recruiting

• 1 other identifier: Silara201901
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Aortic Stenosis with or without Moderate or Lower Degree Regurgitation

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Rate of All-cause Mortality

  Percentage of subjects who died from all causes in this population.

  12 months

Secondary Outcomes (18)

• Rate of Device Success

  Immediate post- procedure

• Rate of Procedure Success

  Immediate post- procedure

• Delivery System Performance

  Immediate post- procedure

• Retrieval System Performance(if using)

  Immediate post- procedure

• Exchange Systerm Evaluation

  Immediate post- procedure

Study Arms (1)

Severe Aortic Valve Stenosis

EXPERIMENTAL

Patients will be treated with Transcatheter Aortic Valve Systerm

Device: Transcatheter Aortic Valve System

Interventions

Transcatheter Aortic Valve System DEVICE

Procedure: Transcatheter aortic valve replacement

Severe Aortic Valve Stenosis

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥70 years old;
• Symptomatic severe aortic stenosis determined by echocardiogram, defined as: mean gradient ≥40 mmHg or peak jet velocity ≥4.0 m/s, or an aortic valve area \<0.8 cm2 or aortic valve area index \<0.5 cm2/m2.
• NYHA Functional Class ≥II;
• Life expectancy after aortic valve implantation thought to be \>1 year;
• Native valvular or peripheral vascular anatomy is appropriate for TAVR;
• Patient is assessed by at least two cardiothoracic surgeons and recorded as not suitable for surgery;
• Patient can understand the purpose of the study, voluntarily participates and signs the informed consent form and is willing to accept the relevant examination and clinical follow-up visits.

You may not qualify if:

• Anatomy is not appropriate for percutaneous valve implantation. Native valve annulus diameter is not in the scope of application(native TAV diameter ≤21mm, or ≥30mm);
• Evidence of an acute myocardial infarction within 30 days prior to the study procedure, defined as: Q-wave myocardial infarction, or non-Q-wave myocardial infarction, with CK-MB≥2 ULN/or elevated TN (WHO definition);
• Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization);
• Pre-existing prosthetic valve in any position(except severely dysfunctional aortic bioprosthesis), or severe (\>3+) mitral insufficiency, or Gorlin syndrome;
• Hematological abnormality, defined as: Leukopenia (WBC \<3x10\^9/L), acute anemia (Hb \<90g/L), or thrombocytopenia (platelet count\<50×109/L),history of bleeding diathesis or coagulopathy;
• Hemodynamic unstable requiring myocardial contractile support or mechanical cardiac assistance;
• Severe ventricular insufficiency. Left ventricular ejection fraction (LVEF) \<20%;
• Echocardiographic evidence of intra-cardiac thrombus or vegetation etc.;
• Active pepticulcer or upper GI bleeding within 3 months prior to the study procedure;
• Cerebral Vascular Accident (CVA) within 3 months prior to the study procedure, including TIA;
• A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, or sensitivity to contrast media, which cannot be adequately pre-medicated;
• Patients with infective endocarditis or other active stage of infection;
• Currently participating in an investigational drug or another device trial.

Sponsors & Collaborators

• Chengdu Silara Meditech Inc.: lead

Study Sites (1)

Fuwai Hospital, CAMS&PUMC

Beijing, China

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Yongjian Wu

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moyang Wang

CONTACT

(86)-010-68314466; wangmoyang1983@vip.sina.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: April 28, 2021
• First Posted: May 19, 2021
• Study Start: December 16, 2020
• Primary Completion: December 31, 2022
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)