Siegel™ Transcatheter Aortic Valve Replacement System (TAVR) Early Feasibility Study

NCT06680427 | Active Not Recruiting DMC FDA Device

• 1 other identifier: MR-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 8

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.

Conditions

Aortic Stenosis Symptomatic

Keywords

Transcatheter Aortic Valve Replacement; Aortic Stenosis

Outcome Measures

Primary Outcomes (2)

• Technical success of implantation of the Siegel TAVR

  Technical success will be reported as freedom from mortality, successful device implant, and freedom from surgery or intervention related to the device.

  Immediate post procedure

• All-cause mortality or disabling stroke

  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

  30 Days

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Device: Siegel Transcatheter Aortic Valve (TAVR)

Interventions

Siegel Transcatheter Aortic Valve (TAVR) DEVICE

Replacement of native aortic valve with the Siegel Transcatheter Aortic Valve (TAVR) by a transfemoral approach.

Treatment Arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects will be excluded for entry in this study if any of the following conditions are met:
• Anatomical
• Anatomy precluding safe placement of Siegel TAVR
• Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
• 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.
• Severe basal septal hypertrophy with outflow gradient Clinical
• Evidence of an acute myocardial infarction ≤ 30 days before enrollment.
• Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
• Blood dyscrasias as defined: leukopenia (WBC \< 3000 cell/mL, anemia (Hgb \< 9 g/dL), thrombocytopenia (platelet count \< 50,000 cells/mL), history of bleeding diathesis or coagulopathy.
• Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization

Sponsors & Collaborators

• MiRus: lead

Study Sites (8)

Cedars-Sinai Medical Center

Los Angeles, California, 90071, United States

Location

Stanford

Palo Alto, California, 94304, United States

Location

NCH Healthcare System

Naples, Florida, 34102, United States

Location

Piedmont Healthcare

Atlanta, Georgia, 30309, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Atlantic Health System

Morristown, New Jersey, 07960, United States

Location

Columbia University Medical Center/ NYPH

New York, New York, 10032, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

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: November 5, 2024
• First Posted: November 8, 2024
• Study Start: March 26, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-09

Locations

US (8)