Siegel™ Transcatheter Aortic Valve Replacement System (TAVR) Early Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Stenosis Symptomatic
- Sponsor
- MiRus
- Enrollment
- 30
- Locations
- 8
- Primary Endpoint
- Technical success of implantation of the Siegel TAVR
- Status
- Active, not recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
The Siegel™ Transcatheter Aortic Valve (TAVR) early feasibility study objective is to assess the acute and long-term safety and feasibility of the Siegel TAVR device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement.
Detailed Description
The Siegel™ Transcatheter Aortic Valve (TAVR) Early Feasibility Study is a prospective, non-randomized, single-arm, multi-center study conducted in the US. The primary objective is to assess the acute and long-term safety and feasibility of the Siegel TAVR device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects are eligible for entry in this study if all the following conditions are met:
- •Symptomatic, severe native aortic stenosis in subjects 50 years or older Aortic Valve Area (AVA) ≤ 1.0 cm2 or Aortic Valve Area (AVA) index ≤ 0.6 cm2/m2 and Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg or dimensionless Index \<0.25
- •New York Heart Association Functional Class ≥ 2
- •Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team (composed of an experienced interventional cardiologist and an experienced cardiac surgeon)
- •Eligible for transfemoral delivery of the Siegel TAVR
- •Native aortic annulus suitable for safe placement of Siegel 23mm or 26mm transcatheter heart valve (preprocedural measurements by Transthoracic Echocardiogram (TTE) and Computed Tomography (CT) of area derived aortic annulus diameter)
- •Understands the study requirements and the treatment procedures and provides written informed consent
- •Subject agrees to complete all required scheduled follow-up visits.
Exclusion Criteria
- •Subjects will be excluded for entry in this study if any of the following conditions are met:
- •Anatomy precluding safe placement of Siegel TAVR
- •Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
- •Pre-existing prosthetic heart valve in any position (note, mitral ring is not an exclusion).
- •Unicuspid or bicuspid aortic valve
- •Severe aortic regurgitation (\>3+)
- •Severe mitral or severe tricuspid regurgitation(\>3+) requiring intervention.
- •Moderate to severe mitral stenosis.
- •Hypertrophic obstructive cardiomyopathy
- •Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment.
Outcomes
Primary Outcomes
Technical success of implantation of the Siegel TAVR
Time Frame: Immediate post procedure
Technical success will be reported as freedom from mortality, successful device implant, and freedom from surgery or intervention related to the device.
All-cause mortality or disabling stroke
Time Frame: 30 Days
Mortality will be reported as rate of death/mortality at 30 days. Disabling stroke will be reported according to Valve Academic Research Consortium (VARC-3) Guidelines