Moderate aortic stenosis
Conditions
Interventions
Transcatheter aortic valve replacement using MDT-2121 TAVR system
Sponsors
Sakaguchi Koyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Moderate AS, defined as follows by transthoracic echo (TTE) as assessed by the ECL: - AVA >1.0 cm2 and 0.6 cm2/m2 if BMI 0.5 cm2/m2 if BMI >= 30 kg/m2 - Max aortic velocity >= 3.0 m/sec and = 20.0 mmHg and = II or - Reduced functional capacity, defined as - 6MWT = 600 pg/ml (or BNP >= 80 pg/ml), or - Persistent AF or Paroxysmal AF episode within 6 months prior to consent, or - Elevated aortic valve calcium score (>1200 AU for females and > 2000 AU for males) as assessed by the MDCT core lab, or - Any of the following by the qualifying TTE as assessed by the ECL: - Global longitudinal strain = 14.0, or - Diastolic dysfunction >= Grade II, or - LVEF < 60%, or - Stroke Volume Index < 35 ml/m2 - Anatomically suitable for transfemoral TAVR using the MDT-2121 system - The subject and the treating physician agree the subject will return for all required follow-up visits
Exclusion criteria
Exclusion criteria: - Age < 65 years - LVEF <= 20% by 2-D echo - Class I indication for cardiac surgery - Contraindication for placement of a bioprosthetic valve - Documented history of cardiac amyloidosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Safety: Composite rate of all-cause mortality, all-stroke, life threatening or fatal bleeding (BARC Type 3 or 4), acute kidney injury (VARC-3 Stage IV), hospitalization due to device or procedure-related complication, or valve dysfunction requiring reintervention at 30 days - Effectiveness: Composite rate of all-cause mortality, heart failure hospitalization or event, or medical instability leading to aortic valve replacement or re-intervention at 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion of subjects alive and with moderately improved quality of life (>= 10 points in KCCQ summary score from baseline) at 1 year - Composite of all-cause mortality and heart failure hospitalizations or events at 2 years - Composite of all-cause mortality, all-stroke, or unplanned CV hospitalizations at 2 years - Heart failure hospitalizations or events at 2 years - All-cause mortality at 2 Years - Unplanned cardiovascular hospitalizations at 2 years - Days alive and free of unplanned cardiovascular hospitalizations at 2 years | — |
Countries
Australia, Austria, Belgium, Canada, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactKoyo Sakaguchi
Medtronic Japan
Outcome results
None listed