N/A
N=222
Portico TAVI Implant With Transfemoral Delivery System
Symptomatic Aortic Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT01493284 ↗Enrolled (actual)
222
Serious AEs
46.0%
Results posted
Apr 2018
Primary outcome: Primary: All Cause Mortality — 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcatheter Aortic Valve Implantation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All Cause Mortality |
8 | — |
| SECONDARY Number of Select Cardiovascular Adverse Events |
8; 7; 3; 7; 5; 8 | — |
| SECONDARY Participant NYHA Classification at Day 30 |
52; 105; 22; 2 | — |
| SECONDARY Number of Participants With Acute Device Success |
216 | — |
Summary
The purpose of this study is to assess the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS).
Eligibility Criteria
Inclusion Criteria
- Subject has given written study Informed Consent for participation prior to procedure.
- Subject is ≥ 18 years of age or legal age in host country.
- Subject's aortic annulus diameter meets the range indicated in the Instructions for use as measured by echocardiogram (echo) or CT conducted within the past 90 days.
- Subject has senile degenerative aortic stenosis with echocardiography (echo) derived mean gradient >40mmHg or jet velocity greater than 4.0 m/s or an initial valve area of grade III) or moderate to severe mitral stenosis.
- Subject has aortic root angulation >70 degrees (horizontal aorta).
- Subject has a pre-existing prosthetic valve or prosthetic ring in any position.
- Subject refuses blood transfusion or surgical valve replacement.
- Subject has left ventricular ejection fraction (LVEF) 3.0 mg/dL (265µmol/L) or end-stage renal disease requiring chronic dialysis.
- Subject has morbid obesity defined as BMI ≥ 40.
- Subject's iliac arteries have severe calcification, tortuosity (>two 90 degree bends), diameter <6mm, or subject has had an aorto-femoral bypass.
- Subject has ongoing infection or sepsis.
- Subject has blood dyscrasias (leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy).
- Subject has a current autoimmune disease that, in the opinion of the Principal Investigator precludes the subject from study participation.
- Subject has significant aortic disease, including:
- aortic abdominal aneurysm (AAA) ≥ 4cm
- thoracic aneurysm (defined as a maximal luminal diameter of 5 cm or greater)
- marked tortuosity
- significant aortic arch atheroma or narrowing of the abdominal or thoracic aorta
- severe tortuosity of the thoracic aorta.
- Subject has a pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the ileo-femoral arteries.
- Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 90 days prior to the index procedure.
- Subject is currently participating in another investigational drug or device study.
- Subject requires emergency surgery for any reason.
- Subject has a life expectancy < 12 months.
- Subject has other medical, social or psychological conditions that, in the opinion of the Subject Selection Committee, preclude the subject from study participation.
- Subject is suffering from dementia or admitted to a chronic care facility which would fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits.
- Subject has a known allergy to contrast media, nitinol alloys, porcine tissue, or bovine tissue.
Data sourced from ClinicalTrials.gov (NCT01493284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.