- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03056573
Assessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access (Portico ALT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark
- Rigshospitalet Copenhagen
-
-
-
-
-
Berlin, Germany
- Deutsches Herzzentrum Berlin
-
Leipzig, Germany
- Herzzentrum Leipzig GmbH
-
Tubingen, Germany
- Universitatsklinikum Tubingen Medizinische Klinik-Kardio
-
-
-
-
-
Milano, Italy
- Ospedale Niguarda Ca'Granda
-
San Donato Milanese, Italy
- Policlínico San Donato
-
-
-
-
-
Amsterdam, Netherlands
- Amsterdam Academic Medical Centre (AMC)
-
Leeuwarden, Netherlands
- Medical Center Leeuwarden
-
Nijmegen, Netherlands
- UMC St Radboud
-
-
-
-
-
Basel, Switzerland
- Basel university hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject has provided written informed consent prior to uploading CT scan to core lab.
- 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 multislice CT conducted within 180 days prior to the index procedure.
Subject has senile degenerative aortic stenosis seen by echocardiography within 90 days of index procedure as measured by:
- mean gradient >40 mmHg
- Peak velocity ≥ 4.0 m/s
- Doppler Velocity Index <0.25
- Aortic valve area (AVA) of ≤ 1.0 cm2 or indexed EOA ≤ 0.6 cm2/m2).
- Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of Class II, or greater or other symptoms of aortic stenosis (e.g. syncope).
Subject is deemed high operable risk and preferred TAVI delivery route is alternate access (subclavian/axillary or direct aortic) per the medical opinion of the center's heart team and confirmed by SSC.
- High risk is defined as an STS mortality > 8% or documented heart team agreement ≥ high risk for SAVR due to frailty or co-morbidities
Exclusion Criteria:
- Subject is unwilling or unable to comply with all study-required follow-up evaluations.
- Subject has a documented history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within 6 months (less than or equal to 180 days) prior to the index procedure.
- Subject has carotid artery disease requiring intervention.
- Subject has evidence of a myocardial infarction (MI) within 30 days prior to patient index procedure.
- Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
- Subject has severe mitral valvular regurgitation.
- Subject has severe mitral stenosis.
- Subject has a pre-existing prosthetic cardiac device, valve, or prosthetic ring in any position.
- Subject refuses any blood product transfusion.
- Subject has resting left ventricular ejection fraction (LVEF) less than 20%.
- Subject has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization.
- Subject has had a percutaneous interventional or other invasive cardiovascular or peripheral vascular procedure less than or equal to 14 days prior to index procedure.
- Subject has severe basal septal hypertrophy that would interfere with transcatheter aortic valve placement.
- Subject has a history of, or is currently diagnosed with, endocarditis.
- There is imaging evidence of intracardiac mass, thrombus, or vegetation.
- Subject is considered hemodynamically unstable (requiring inotropic support or mechanical heart assistance).
- Subject is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure.
- Subject with severe pulmonary disease as determined by STS score.
- Subject is on chronic oral steroid therapy.
- Subject has a documented hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
- Subject has renal insufficiency as evidenced by a serum creatinine greater than 3.0 mg/dL (265.5 µmol/L) or end-stage renal disease requiring chronic dialysis.
- Subject has morbid obesity defined as a BMI greater than or equal to 40.
- Subject has ongoing infection or sepsis.
- Subject has uncontrolled blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb<9 mg/dL), thrombocytopenia (platelet count <50,000 cells/mm3,).
- Anatomy falling outside the recommended values in the IFU, unless specifically approved by the Subject Selection Committee.
- Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within 90 days prior to the index procedure.
- Subject is currently participating in another investigational drug or device study, unless approved by the Sponsor.
- Subject has/had emergency surgery for any reason within 30 days of the index procedure.
- Subject has a life expectancy less than 1 year.
- Subject has other medical, social or psychological conditions that, in the opinion of the Principal Investigator or the Subject Selection Committee, preclude the subject from study participation.
- Subject is diagnosed with a state of dementia which would fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits.
- Subject has a documented allergy to contrast media that cannot adequately be treated, nitinol alloys, porcine tissue, or bovine tissue.
- Significant aortic disease including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater
- Subjects with severe pulmonary hypertension and severe RV dysfunction
- Subjects with hypertrophic cardiomyopathy
Transaortic Subject Cohort Specific Exclusion Criteria
Subjects are not eligible for participation in the TAo access arm if they meet any of the following exclusion criteria:
- Subject has a chest condition (anatomical or otherwise) that prevents TAo access.
- Subject has pre-existing patent RIMA graft that would preclude access.
- Subject has a porcelain aorta, defined as an extensive circumferential calcification of the ascending aorta that would complicate TAo access.
Subclavian/Axillary Subject Cohort Specific Exclusion Criteria
Subjects are not eligible for participation in the subclavian/axillary access arm if they meet any of the following exclusion criteria:
- Subject's access vessel (subclavian/axillary) diameter will not allow for introduction of the 18/19 Fr delivery system.
- Subject's subclavian/axillary arteries have severe calcification and/or tortuosity.
- Subject has a history of LIMA/RIMA graft that would preclude access
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Subclavian/axillary
Subclavian/axillary access route
|
Subclavian /Axillary TAVR implant
|
Experimental: Transaortic
Transaortic access route
|
Transaortic TAVR implant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Major Vascular Complications
Time Frame: 30 Days
|
Major Vascular complication is defined as
|
30 Days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of All- Cause Mortality
Time Frame: 30 Days
|
30 Days
|
|
Number of All- Cause Mortality
Time Frame: 1 Year
|
1 Year
|
|
Cardiovascular Mortality
Time Frame: 30 Days
|
Any 1 of the following criteria:
|
30 Days
|
Cardiovascular Mortality
Time Frame: 1 year
|
Any 1 of the following criteria:
|
1 year
|
Number of Participants With Disabling Stroke
Time Frame: 30 Days
|
Disabling stroke is an mRS score of 2 or more at 90 days and an increase of at least 1 mRS category from an individual's prestroke baseline
|
30 Days
|
Number of Participants With Disabling Stroke
Time Frame: 1 Year
|
Disabling stroke is an mRS score of 2 or more at 90 days and an increase of at least 1 mRS category from an individual's prestroke baseline
|
1 Year
|
Number of Participants With Non-disabling Strokes
Time Frame: 30 Days
|
Non-disabling is an mRS score of <2 at 90 days or 1 that does not result in an increase of at least 1 mRS category from an individual's prestroke baseline
|
30 Days
|
Number of Participants With Non-disabling Strokes
Time Frame: 1 Year
|
Non-disabling is an mRS score of <2 at 90 days or 1 that does not result in an increase of at least 1 mRS category from an individual's prestroke baseline
|
1 Year
|
Number of Participants With Life Threatening Bleeding Requiring Transfusion
Time Frame: 30 Days
|
Life threatening bleeding requiring transfusion
|
30 Days
|
Number of Participants With Life Threatening Bleeding Requiring Transfusion
Time Frame: 1 Year
|
Life threatening bleeding requiring transfusion
|
1 Year
|
Number of Participants With Acute Kidney Injury Requiring Dialysis
Time Frame: 30 Days
|
Increase in serum creatinine to greater than or equal to 300% (3 X increase compared with baseline) or serum creatinine of ≥ 4.0 mg/dL (354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)or Urine output <0.3 mL/kg per hour for ≥24 hours or anuria for ≥12 hours.
Patients receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria
|
30 Days
|
Number of Participants With Acute Kidney Injury Requiring Dialysis
Time Frame: 1 Year
|
Increase in serum creatinine to greater than or equal to 300% (3 X increase compared with baseline) or serum creatinine of ≥ 4.0 mg/dL (354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)or Urine output <0.3 mL/kg per hour for ≥24 hours or anuria for ≥12 hours.
Patients receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria
|
1 Year
|
Number of Participants With Composite of Periprocedural Encephalopathy, All Stroke and All TIA
Time Frame: 30 Days
|
Stroke is an acute symptomatic episode of neurological dysfunction attributed to a vascular cause. Transient Ischemic Attack (TIA) is a transient (less than 24 hrs) episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. No evidence of infarction if imaging performed. Encephalopathy is defined as altered mental state (e.g., seizures, delirium, confusion, hallucinations, dementia, coma, psychiatric episode). |
30 Days
|
Number of Participants With Composite of Periprocedural Encephalopathy, All Stroke and All TIA
Time Frame: 1 Year
|
Stroke is an acute symptomatic episode of neurological dysfunction attributed to a vascular cause. Transient Ischemic Attack (TIA) is a transient (less than 24 hrs) episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. No evidence of infarction if imaging performed. Encephalopathy is defined as altered mental state (e.g., seizures, delirium, confusion, hallucinations, dementia, coma, psychiatric episode). |
1 Year
|
Number of Participants With Moderate and Severe Aortic Regurgitation
Time Frame: 1 year
|
1 year
|
|
Change in NYHA Class From Baseline to 30 Days
Time Frame: Baseline to 30 days
|
New York Heart Association (NYHA) functional classification provides a way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina pain. 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. |
Baseline to 30 days
|
Change in Six Minute Walk Test From Baseline as Compared to 30 Days
Time Frame: Baseline to 30 days
|
The Six Minute Walk Test (6MWT)measures the distance that a patient can walk in a period of 6 minutes.
The distance walked is measured in meters.
This test measures the patients' functional status.
The more meters a patient can walk over baseline indicates improvement in functional status.
|
Baseline to 30 days
|
Change in Effective Orifice Area From Baseline as Compared to 30 Days
Time Frame: Baseline to 30 days.
|
Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.
|
Baseline to 30 days.
|
Number of Participants With Overall Acute Device Success
Time Frame: 7 days
|
Acute device success is defined as a subject who achieves a) successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system, b) correct position of the device in the proper anatomical location, c) intended performance of the prosthetic heart valve, and d) only 1 valve implanted in the proper anatomical location. Device success is a 'technical' composite endpoint meant to characterize the acute device and procedural factors which underlie vascular access, delivery, and performance of the TAVI system. Echocardiography should be routinely utilized as the standard for measuring prosthetic valve stenosis and regurgitation immediately after TAVI, and should always be performed in a resting state, either within 24-48 h after the index procedure or before hospital discharge. |
7 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SJM-CIP-10144
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aortic Valve Stenosis
-
Anteris Technologies Ltd.Active, not recruitingAortic Stenosis | Aortic Valve Calcification | Severe Aortic Valve Stenosis | Symptomatic Aortic StenosisUnited States
-
The Medicines CompanyCompletedTranscatheter Aortic Valve Replacement | Aortic Valve Replacement | Severe Aortic StenosisNetherlands, Germany, United Kingdom, Canada, France, Italy, Switzerland
-
Ningbo Jenscare Biotechnology Co., Ltd.UnknownAortic Regurgitation | Severe Aortic Stenosis
-
Anteris Technologies Ltd.Active, not recruitingAortic Valve Calcification | Severe Aortic Valve Stenosis | Symptomatic Aortic StenosisGeorgia
-
Edwards LifesciencesCompletedAortic Valve Stenosis | Aortic Valve Stenosis With Insufficiency | Regurgitation, Aortic Valve | Aortic Valve IncompetenceUnited States
-
Sorin Group USA, Inc.TerminatedAortic Valve Stenosis | Aortic Valve Stenosis With Insufficiency | Regurgitation, Aortic Valve | Aortic Valve IncompetenceUnited States
-
Edwards LifesciencesActive, not recruitingAortic Stenosis | Aortic Regurgitation | Symptomatic Aortic StenosisChina
-
BC Centre for Improved Cardiovascular HealthEdwards LifesciencesUnknownTranscatheter Aortic Valve Implantation | Severe Aortic StenosisCanada
-
Genesis Medtech CorporationRecruitingDiseases of Aortic Valve | Aortic Stenosis DiseaseChina
-
Hospices Civils de LyonRecruiting
Clinical Trials on Subclavian /Axillary TAVR implant
-
Centre Hospitalier Universitaire de NīmesCompletedCentral Venous CatheterizationFrance
-
China-Japan Friendship HospitalUnknownMechanical Complication of Cardiac PacemakerChina
-
Castilla-La Mancha Health ServiceUnknownComplication | Defibrillators | Pacemakers | Pacemaker Electrode Lead FractureSpain
-
Abbott Medical DevicesCompletedAortic Valve StenosisUnited Kingdom, Netherlands, Spain, Germany, Belgium, Australia, Denmark, Canada, Italy, France, Israel, Lithuania, Switzerland