Status:
ACTIVE_NOT_RECRUITING
SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation
Lead Sponsor:
InnovHeart
Conditions:
Mitral Regurgitation
Valve Heart Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is a prospective, single-arm, multi-center feasibility clinical study of the SATURN TA System for the treatment of NYHA Class ≥ II patients with severe functional mitral regurgitation who a...
Eligibility Criteria
Inclusion
- Age 18 years or older.
- Severe functional mitral regurgitation (≥ Grade 3+).
- NYHA functional Class ≥ II. If Class IV, patient must be ambulatory.
- Treatment and compliance with optimal guideline-directed medical therapy (GDMT) for heart failure for at least 30 days.
- Not a suitable candidate for open mitral valve surgery due to high operative risk, as determined by the Heart Team.
- Able to complete quality-of-life assessment (KCCQ).
- General
Exclusion
- Excessive frailty or comorbid conditions that preclude the anticipated benefit of the valve replacement.
- Life expectancy \<1 yr due to noncardiac conditions.
- Active endocarditis.
- Active systemic infection.
- Modified Rankin Scale ≥4 disability.
- Hemodialysis/ chronic renal failure (eGFR \< 35 mL/min/m2).
- Pulmonary arterial hypertension (fixed PAS \< 60mmHg). 8) COPD on home oxygen.
- 9\) Refuses blood transfusions. 10) Documented bleeding or coagulation conditions (hypo- or hyper-coagulable states).
- 11\) Severe connective tissue disease under chronic immunosuppressive or cortisone therapy.
- 12\) Pregnant/ lactating. Females of childbearing age must be willing to take contraceptives.
- 13\) Participating in other investigational studies likely to confound the results or affect the study.
- 14\) Unable to consent. 15) Unable or unwilling to comply with study Follow-up. 16) Patients classified as "vulnerable patients".
- Cardiovascular
Key Trial Info
Start Date :
August 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04464876
Start Date
August 19 2020
End Date
December 1 2024
Last Update
May 22 2024
Active Locations (3)
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1
Rigshospitalet University Hospital of Copenhagen
Copenhagen, Denmark
2
Heart And Vascular Center, Semmelweis University
Budapest, Hungary
3
Vilnius University Hospital Santaros klinikos
Vilnius, Lithuania