- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01493284
Portico TAVI Implant With Transfemoral Delivery System
Assessment Of The St. Jude Medical Portico™ Transcatheter Aortic Valve Implant (TAVI) And The SJM TAVI Transfemoral Delivery System (Portico TF EU)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Adelaide, Australien
- Adelaide Royal Hospital
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Copenhagen, Danmark
- Rigshospitalet Copenhagen
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Leicester, Det Forenede Kongerige
- Glenfield Hospital
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London, Det Forenede Kongerige
- St. Thomas' Hospital
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London, Det Forenede Kongerige
- Kings College
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Plymouth, Det Forenede Kongerige
- Derriford Hospital, Plymouth
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Northern Ireland
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Belfast, Northern Ireland, Det Forenede Kongerige, BT12 6BA
- Royal Victoria Hospital
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Leeuwarden, Holland
- Medical Center Leeuwarden
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Bad Nauheim, Tyskland
- Kerckhoff Klinik
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Bernau, Tyskland
- Heart Center Bernau
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Hamburg, Tyskland
- Asklepios Klinik-St. Georg
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Jena, Tyskland
- Klinikum der Universität Jena
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Karlsruhe, Tyskland
- Klinik fur Herzhirurgie Karlruhe GmbH
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Leipzig, Tyskland
- Herzzentrum Leipzig
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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 <1.0 cm2 (or aortic valve area index ≤ 0.6 cm2/m2). (Baseline measurement taken by echo within 30 days of procedure).
- Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II or greater.
- Subject is deemed high operable risk and suitable for TAVI per the medical opinion of the Subject Selection Committee (See Section 3.1 for the definition of the Subject Selection Committee)
- Subject's predicted operative mortality or serious, irreversible morbidity risk is <50% at 30 days.
- In the opinion of the Subject Selection Committee and based upon angiographic measurements, the subject has suitable peripheral vessels and aorta to allow for access of the 18 French delivery system.
- Subject has structurally normal cardiac anatomy.
- Subject is willing and able to comply with all required follow-up evaluations.
Exclusion Criteria:
- Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months (≤180 days) of the index procedure.
- Subject has carotid artery disease requiring intervention.
- Subject has evidence of a myocardial infarction (MI) within the past 6 months (≤180 days) of the index procedure.
- Subject has hypertrophic cardiomyopathy.
- Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
- Subject has mitral or tricuspid valvular regurgitation (>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) < 20%.
- The subject has documented, untreated coronary artery disease (CAD) requiring revascularization.
- Subject has severe basal septal hypertrophy.
- Subject has had a percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 14 days of the index procedure.
- Subject has a history of or has active endocarditis.
- Subject has echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
- Subject has hemodynamic instability (requiring inotropic support or mechanical heart assistance).
- Subject is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure.
- Subject with significant pulmonary disease.
- Subject has significant chronic steroid use.
- Subject has a known hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
- Subject has renal insufficiency as evidenced by a serum creatinine > 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Transfemoral Access
Transfemoral Access for transcatheter aortic valve implant
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Placement of the SJM Portico aortic valve with a transfemoral delivery system
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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All Cause Mortality
Tidsramme: 30 days
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Number of participants that reported all cause mortality
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30 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Select Cardiovascular Adverse Events
Tidsramme: 30 days
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Number of participants with select cardiovascular adverse events
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30 days
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Participant NYHA Classification at Day 30
Tidsramme: day 30
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The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256. |
day 30
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Number of Participants With Acute Device Success
Tidsramme: 7 days
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7 days
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Ganesh Manoharan, MD, Royal Victoria Hospital
Publikationer og nyttige links
Generelle publikationer
- Walther T, Manoharan G, Linke A, Mollmann H, Holzhey D, Worthley SG, Kim WK, Schafer U. Incidence of new-onset left bundle branch block and predictors of new permanent pacemaker following transcatheter aortic valve replacement with the Portico valve. Eur J Cardiothorac Surg. 2018 Sep 1;54(3):467-474. doi: 10.1093/ejcts/ezy078.
- Linke A, Holzhey D, Mollmann H, Manoharan G, Schafer U, Frerker C, Worthley SG, van Boven AJ, Redwood S, Kovac J, Butter C, Sondergaard L, Lauten A, Schymik G, Walther T. Treatment of Aortic Stenosis With a Self-Expanding, Resheathable Transcatheter Valve: One-Year Results of the International Multicenter Portico Transcatheter Aortic Valve Implantation System Study. Circ Cardiovasc Interv. 2018 Feb;11(2):e005206. doi: 10.1161/CIRCINTERVENTIONS.117.005206.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1105
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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