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To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis | Clinical Trials | Clareo Health

RECRUITINGNA

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

A Prospective, Multi-center, Single-arm Clinical Trial to Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis With or Without Moderate or Lower Degree Regurgitation

NCT04893603•Chengdu Silara Meditech Inc.

View on ClinicalTrials.gov

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

Detailed Description

Transcatheter Aortic Valve System (Chengdu Silara Medtech Inc. ,Chengdu, China) will be used for this study.

Eligibility

Age

70 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥70 years old;
•2. 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.
•3. NYHA Functional Class ≥II;
•4. Life expectancy after aortic valve implantation thought to be \>1 year;
•5. Native valvular or peripheral vascular anatomy is appropriate for TAVR;
•6. Patient is assessed by at least two cardiothoracic surgeons and recorded as not suitable for surgery;
•7. 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.

Exclusion Criteria

•1. 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);
•2. 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);
•3. Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization);
•4. Pre-existing prosthetic valve in any position(except severely dysfunctional aortic bioprosthesis), or severe (\>3+) mitral insufficiency, or Gorlin syndrome;
•5. 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;
•6. Hemodynamic unstable requiring myocardial contractile support or mechanical cardiac assistance;
•7. Severe ventricular insufficiency. Left ventricular ejection fraction (LVEF) \<20%;
•8. Echocardiographic evidence of intra-cardiac thrombus or vegetation etc.;
•9. Active pepticulcer or upper GI bleeding within 3 months prior to the study procedure;
•10. Cerebral Vascular Accident (CVA) within 3 months prior to the study procedure, including TIA;
+3 more criteria

Locations (1)

Fuwai Hospital, CAMS&PUMC

Beijing, China

Key Dates

Start Date

December 16, 2020

Primary Completion Date

December 31, 2022

Completion Date

December 31, 2026

Last Updated

May 19, 2021

Enrollment

120

ESTIMATED participants

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve System

DEVICE

Contacts

Moyang Wang

CONTACT

(86)-010-68314466 wangmoyang1983@vip.sina.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 19, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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