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

NCT07278310 | Recruiting DMC FDA Device

• 1 other identifier: MR-002
• Study Type: interventional
• Target: 1,025
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.

Conditions

Symptomatic Severe Native Aortic Stenosis; Aortic Stenosis

Keywords

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• All-cause mortality, all stroke and cardiovascular rehospitalization

  The primary endpoint is the composite of all-cause mortality, all stroke, and cardiovascular rehospitalization (valve-related or procedure-related per VARC-3) at 1 year.

  1 Year

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Investigational Device- Siegel TAVR

Device: Siegel TAVR Device

Control Arm

ACTIVE COMPARATOR

Commercially available TAVR device- Sapien TAVR or Evolute TAVR

Device: TAVR Device

Interventions

TAVR Device DEVICE

Commercially available TAVR Device

Control Arm

Siegel TAVR Device DEVICE

Siegel TAVR Device

Treatment Arm

Eligibility Criteria

• Age: 18 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:
• Age ≥ 18 years
• Symptomatic, severe native calcific aortic stenosis in subjects at low, intermediate or high surgical risk AVA ≤ 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 or 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 a TAVR
• Native aortic annulus suitable for safe placement of Siegel 23mm, 26mm or 29 mm transcatheter heart valve. Preprocedural measurements by TTE and CT of aortic annulus area (23mm: 330- 440 mm2 , 26mm: 430-550 mm2, 29mm: 540-690 mm2)
• 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
• Cardiac anatomy precluding safe placement of a transcatheter aortic valve.
• Iliofemoral vessel characteristics (vessel diameter \<5.5mm for smaller THV systems \[20-26mm valve sizes\] or \<6.0mm for larger THV systems \[29mm or larger valve sizes\]) that would preclude safe placement of commercially available transcatheter aortic valves (SAPIEN 3 or Evolut)
• Pre-existing prosthetic heart valve or ring except in the mitral position.
• Unicuspid aortic valve
• Severe aortic regurgitation (\>3+)
• Severe mitral or severe tricuspid regurgitation(\>3+) requiring intervention.
• Moderate to severe mitral stenosis.
• Hypertrophic obstructive cardiomyopathy (HOCM)
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment.
• Significant aortic disease including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5.5 cm or greater or ascending aortic aneurysm defined as maximal luminal diameter 5 cm or greater.
• 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

Sponsors & Collaborators

• MiRus: lead

Study Sites (1)

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

RECRUITING

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: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 12, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)