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This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected.
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected. As part of the study analysis, resource utilization together with the Quality of Life questionnaires data will provide an important input into cost effectiveness analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoreValve aortic valve | Implantation of CoreValve aortic valve via direct aortic approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoreValve aortic valve | Device | Implantation of CoreValve aortic valve via direct aortic approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality | Kaplan-Meier estimate of 30-day all-cause mortality. | 30 days post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | The combined safety endpoint is defined as a composite of:
|
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Inclusion Criteria:
Exclusion Criteria:
Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated
Sepsis, including active endocarditis
Recent myocardial infarction (<30 days)
Left ventricular or atrial thrombus by echocardiography
Uncontrolled atrial fibrillation
Mitral or tricuspid valvular insufficiency (>grade II)
Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve)
Evolutive or recent (within 6 months of implant procedure) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
Patients with:
Bleeding diathesis or coagulopathy
Patient refuses blood transfusion
Estimated life expectancy of less than 12 months unless TAVI is performed
Creatine clearance <20 mL/min
Active gastritis or peptic ulcer disease
Pregnancy or intent to become pregnant during study follow up
Patient is participating in another trial that may influence the results of this study
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Patients with severe aortic stenosis who are scheduled for an elective transcatheter aortic valve implantation and who are selected (e.g. because of an calcified femoral artery) to receive the CoreValve® device via direct aortic access.
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| Name | Affiliation | Role |
|---|---|---|
| Neil Moat, M.D. | The Royal Brompton Hospital | Principal Investigator |
| Giuseppe Bruschi, M.D. | Azienda spedaliera Niguarda Ca' Granda Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemocnice Podlesi Trinec | Třinec | 739 61 | Czechia | |||
| Hopital de Rangueil |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled | All subjects enrolled in the trial |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled population.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled | All subjects enrolled in the trial |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | All-cause Mortality | Kaplan-Meier estimate of 30-day all-cause mortality. | all subjects who underwent an attempted implant of whom all were implanted with the CoreValve device via the direct aortic approach | Posted | Number | 95% Confidence Interval | Percentage of subjects | 30 days post-implant |
|
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Adverse event data were collected up to 1 year post-implant procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Implanted Population | all subjects who underwent an attempted implant of whom all were implanted with the CoreValve device via the direct aortic approach |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke-TIA | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injury, poisoning and procedural complications | Systematic Assessment | Adverse events not associated with the use of the study device were collected without a specific adverse event term |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maarten Hollander | Medtronic Bakken Research Center | +31620534428 | Maarten.Hollander@medtronic.com |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D006349 | Heart Valve Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006331 | Heart Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| 1, 6 and 12 months |
| Toulouse |
| 31059 CEDEX 9 |
| France |
| Universitätsklinikum Halle (Saale) | Halle | 06120 | Germany |
| Azienda spedaliera Spedali Civili Di Brescia | Brescia | 25123 | Italy |
| Azienda spedaliera Niguarda Ca' Granda Milano | Milan | 20162 | Italy |
| Catharina Ziekenhuis | Eindhoven | 5623 EJ | Netherlands |
| Medisch centrum Leeuwarden | Leeuwarden | Netherlands |
| Brighton and Sussex University Hospitals NHS Trust, Royal Sussex County Hospital | Brighton | United Kingdom |
| Royal Brompton & Harefield NHS Trust | London | SW3 6NP | United Kingdom |
| Not willing to attend 1-year visit |
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| Valve explanted |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Secondary | Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | The combined safety endpoint is defined as a composite of:
| all subjects who underwent an attempted implant of whom all were implanted with the CoreValve device via the direct aortic approach | Posted | Number | 95% Confidence Interval | Percentage of subjects | 1, 6 and 12 months |
|
|
|
| 16 |
| 92 |
| 72 |
| 92 |
| 68 |
| 92 |
| Bleeding | Vascular disorders | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | Systematic Assessment |
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| New or worsened conduction disturbances and arrhythmias without pacemaker implant | Cardiac disorders | Systematic Assessment |
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| Permanent Pacemaker Implantation | Surgical and medical procedures | Systematic Assessment |
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| Vascular access site and access-related complications | Injury, poisoning and procedural complications | Systematic Assessment |
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| Failure of current therapy for AS requiring hospitalization or worsening congestive heart failure | Cardiac disorders | Systematic Assessment |
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| Sternotomy or thoracotomy related event | Surgical and medical procedures | Systematic Assessment |
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| General disorders | Systematic Assessment | Adverse events not associated with the use of the study device were collected without a specific adverse event term |
|
| Cardiac disorders | Systematic Assessment | Adverse events not associated with the use of the study device were collected without a specific adverse event term |
|
| Infections and infestations | Systematic Assessment | Adverse events not associated with the use of the study device were collected without a specific adverse event term |
|
| Injury, poisoning and procedural complications | Systematic Assessment | Adverse events not associated with the use of the study device were collected without a specific adverse event term |
|
|
| Cardiac disorders | Systematic Assessment | Adverse events not associated with the use of the study device were collected without a specific adverse event term |
|
| General disorders | Systematic Assessment | Adverse events not associated with the use of the study device were collected without a specific adverse event term |
|
| Product Issues | Systematic Assessment | Adverse events not associated with the use of the study device were collected without a specific adverse event term |
|
| Renal and urinary disorders | Systematic Assessment | Adverse events not associated with the use of the study device were collected without a specific adverse event term |
|
| Infections and infestations | Systematic Assessment | Adverse events not associated with the use of the study device were collected without a specific adverse event term |
|
| Surgical and medical procedures | Systematic Assessment | Adverse events not associated with the use of the study device were collected without a specific adverse event term |
|
| Vascular disorders | Systematic Assessment | Adverse events not associated with the use of the study device were collected without a specific adverse event term |
|
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| Title | Measurements |
|---|---|
|