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Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis (STAR Trial)

Status: Recruiting

To assess the short and long-term safety and effectiveness of the Siegel transcatheter aortic valve replacement (TAVR) device in adults with symptomatic and severe aortic stenosis who are eligible for TAVR. Subjects are randomized to either commercial (FDA approved) or Siegel TAVR device.

I'm interested

Sex: Male or Female
Age: 18 years and over
Healthy Volunteers:
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• At least 18 years old
• Diagnosed with severe and symptomatic aortic stenosis
• Able to have an aortic valve replacement performed transfemorally (via blood vessels in the leg)
Exclusion Criteria:

• Heart attack within 30 days
• Stroke/stroke-like event within 6 months
• Gastrointestinal bleed within 3 months
• Significant kidney or liver disease
• Severe lung disease or continuous home oxygen use
Interventions:

Drug/Device: Siegel TAVR

Conditions:

severe symptomatic aortic stenosis requiring valve replacement

Keywords:

severe aortic stenosis, Siegel, TAVR

Contact(s): Sara Poggio - spoggio1@hfhs.org
Principal Investigator: Pedro Villablanca
Principal Investigator ID: pvillab1@hfhs.org
Phase: N/A
See this study on ClinicalTrials.gov

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