ACTIVE_NOT_RECRUITING

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

Conditions

Aortic Stenosis Symptomatic Transcatheter Aortic Valve Replacement Aortic Stenosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-26

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06680427

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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 2. New York Heart Association Functional Class ≥ 2 3. 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) 4. Eligible for transfemoral delivery of the Siegel TAVR 5. 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) 6. Understands the study requirements and the treatment procedures and provides written informed consent 7. Subject agrees to complete all required scheduled follow-up visits.	1. Anatomy precluding safe placement of Siegel TAVR 2. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath. 3. Pre-existing prosthetic heart valve in any position (note, mitral ring is not an exclusion). 4. Unicuspid or bicuspid aortic valve 5. Severe aortic regurgitation (\>3+) 6. Severe mitral or severe tricuspid regurgitation(\>3+) requiring intervention. 7. Moderate to severe mitral stenosis. 8. Hypertrophic obstructive cardiomyopathy 9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment. 10. Severe basal septal hypertrophy with outflow gradient Clinical 11. Evidence of an acute myocardial infarction ≤ 30 days before enrollment. 12. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure 13. 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. 14. Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization 15. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support within the past 30 days. 16. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of enrollment 17. Need for emergency surgery for any reason 18. Ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 30% as measured by resting echocardiogram 19. Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA). 20. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment 21. Renal insufficiency (eGFR \< 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy, or end stage renal disease requiring chronic dialysis 22. GI bleeding within the past 3 months 23. Severe lung disease with Forced Expiratory Volume in 1 second (FEV1) \< 50% predicted or currently on home oxygen 24. History of cirrhosis or any active liver disease 25. Significant frailty as determined by the Heart Team (after objective assessment of frailty parameters). 26. Significant abdominal or thoracic aortic disease (such as porcelain aorta, abdominal aortic aneurysm \> 5.0 cm, severe calcification, aortic coarctation, etc.) that would preclude safe passage of the delivery system or cannulation and aortotomy for surgical AVR . 27. Severe pulmonary hypertension (e.g., pulmonary artery systolic pressure ≥ 2/3 systemic pressure) 28. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin, heparin, molybdenum, rhenium, ticlopidine and clopidogrel, contrast media 29. Ongoing sepsis, including active endocarditis 30. Body Mass Index (BMI) \> 50 kg/m2 31. Subject refuses a blood transfusion 32. Life expectancy \< 24 months due to associated non-cardiac co-morbid conditions 33. Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent 34. Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits) 35. Currently participating in an investigational drug or another investigational device trial 36. Subject is contraindicated for cardiac computed tomography (CT). 37. Subject belongs to a vulnerable population (Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention).

Inclusion Criteria

Exclusion Criteria

1. 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
2. New York Heart Association Functional Class ≥ 2
3. 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)
4. Eligible for transfemoral delivery of the Siegel TAVR
5. 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)
6. Understands the study requirements and the treatment procedures and provides written informed consent
7. Subject agrees to complete all required scheduled follow-up visits.

1. Anatomy precluding safe placement of Siegel TAVR
2. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
3. Pre-existing prosthetic heart valve in any position (note, mitral ring is not an exclusion).
4. Unicuspid or bicuspid aortic valve
5. Severe aortic regurgitation (\>3+)
6. Severe mitral or severe tricuspid regurgitation(\>3+) requiring intervention.
7. Moderate to severe mitral stenosis.
8. Hypertrophic obstructive cardiomyopathy
9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment.
10. Severe basal septal hypertrophy with outflow gradient Clinical
11. Evidence of an acute myocardial infarction ≤ 30 days before enrollment.
12. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
13. 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.
14. Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization
15. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support within the past 30 days.
16. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of enrollment
17. Need for emergency surgery for any reason
18. Ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 30% as measured by resting echocardiogram
19. Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
20. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment
21. Renal insufficiency (eGFR \< 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy, or end stage renal disease requiring chronic dialysis
22. GI bleeding within the past 3 months
23. Severe lung disease with Forced Expiratory Volume in 1 second (FEV1) \< 50% predicted or currently on home oxygen
24. History of cirrhosis or any active liver disease
25. Significant frailty as determined by the Heart Team (after objective assessment of frailty parameters).
26. Significant abdominal or thoracic aortic disease (such as porcelain aorta, abdominal aortic aneurysm \> 5.0 cm, severe calcification, aortic coarctation, etc.) that would preclude safe passage of the delivery system or cannulation and aortotomy for surgical AVR .
27. Severe pulmonary hypertension (e.g., pulmonary artery systolic pressure ≥ 2/3 systemic pressure)
28. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin, heparin, molybdenum, rhenium, ticlopidine and clopidogrel, contrast media
29. Ongoing sepsis, including active endocarditis
30. Body Mass Index (BMI) \> 50 kg/m2
31. Subject refuses a blood transfusion
32. Life expectancy \< 24 months due to associated non-cardiac co-morbid conditions
33. Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent
34. Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)
35. Currently participating in an investigational drug or another investigational device trial
36. Subject is contraindicated for cardiac computed tomography (CT).
37. Subject belongs to a vulnerable population (Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention).

Contacts and Locations

Study Locations (Sites)

Cedars-Sinai Medical Center

Los Angeles, California, 90071

United States

Stanford

Palo Alto, California, 94304

United States

NCH Healthcare System

Naples, Florida, 34102

United States

Piedmont Healthcare

Atlanta, Georgia, 30309

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Atlantic Health System

Morristown, New Jersey, 07960

United States

Columbia University Medical Center/ NYPH

New York, New York, 10032

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: MiRus

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-26

Study Completion Date2025-10

Study Record Updates

Study Start Date2025-03-26

Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

Transcatheter Aortic Valve Replacement
Aortic Stenosis

Additional Relevant MeSH Terms

Aortic Stenosis Symptomatic