Actively Recruiting

Phase Not Applicable
Age: 70Years +
All Genders
NCT04893603

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

Led by Chengdu Silara Meditech Inc. · Updated on 2021-05-19

120

Participants Needed

1

Research Sites

315 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 70Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 70 years or older
  • Symptomatic severe aortic stenosis confirmed by echocardiogram, defined as mean gradient ≥40 mmHg or peak jet velocity ≥4.0 m/s, or an aortic valve area less than 0.8 cm2 or valve area index less than 0.5 cm2/m2
  • New York Heart Association (NYHA) Functional Class II or higher
  • Life expectancy greater than 1 year after valve implantation
  • Appropriate native valve or peripheral vascular anatomy for transcatheter aortic valve replacement (TAVR)
  • Assessed by at least two cardiothoracic surgeons as not suitable for surgery
  • Ability to understand the study, voluntarily consent, and willing to undergo examinations and follow-up visits
Not Eligible

You will not qualify if you...

  • Anatomy not suitable for percutaneous valve implantation; native valve annulus diameter less than 21 mm or more than 30 mm
  • Acute myocardial infarction within 30 days before the procedure
  • Traumatic cardiac surgery within 30 days before the procedure, except coronary revascularization
  • Presence of prosthetic valve anywhere except severely dysfunctional aortic bioprosthesis, severe mitral insufficiency, or Gorlin syndrome
  • Blood disorders: leukopenia, acute anemia, thrombocytopenia, history of bleeding disorder or coagulopathy
  • Hemodynamic instability requiring heart support devices
  • Severe ventricular insufficiency with left ventricular ejection fraction less than 20%
  • Echocardiographic evidence of intra-cardiac thrombus or vegetation
  • Active peptic ulcer or upper gastrointestinal bleeding within 3 months before procedure
  • Stroke or transient ischemic attack within 3 months before procedure
  • Known allergies or contraindications to aspirin, heparin, ticlopidine, clopidogrel, or contrast media not manageable with pre-medication
  • Infective endocarditis or active infection
  • Current participation in another investigational drug or device trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fuwai Hospital, CAMS&PUMC

Beijing, China

Actively Recruiting

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Research Team

M

Moyang Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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