Aortic Stenosis, Valvular Heart Disease
Conditions
Keywords
Transcatheter Aortic valve Implantation, Heart Valve Diseases, Cardiovascular Diseases
Brief summary
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.
Detailed description
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.
Interventions
DEVICECoreValve aortic valve
Implantation of CoreValve aortic valve via direct aortic approach
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Severe symptomatic aortic valve stenosis requiring treatment 2. Acceptable candidate for elective treatment with the Medtronic CoreValve® System according to the most recent version of the Medtronic CoreValve® Instructions For Use 3. 21 years of age or older 4. Patient is willing and able to comply with all protocol-specified follow-up evaluations 5. The patient or legal representative has been informed of the nature of the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form (Patient Informed Consent Form) 6. Patient will receive the CoreValve® device via direct aortic approach TAVI -
Exclusion criteria
1. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated 2. Sepsis, including active endocarditis 3. Recent myocardial infarction (\<30 days) 4. Left ventricular or atrial thrombus by echocardiography 5. Uncontrolled atrial fibrillation 6. Mitral or tricuspid valvular insufficiency (\>grade II) 7. Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve) 8. Evolutive or recent (within 6 months of implant procedure) cerebrovascular accident (CVA) or transient ischemic attack (TIA) 9. Patients with: 1. Vascular conditions that make insertion and endovascular access to the aortic valve impossible, or 2. Symptomatic carotid or vertebral arterial narrowing (\>70%) disease, or 3. Thoracic aortic aneurysm in the path of delivery system 10. Bleeding diathesis or coagulopathy 11. Patient refuses blood transfusion 12. Estimated life expectancy of less than 12 months unless TAVI is performed 13. Creatine clearance \<20 mL/min 14. Active gastritis or peptic ulcer disease 15. Pregnancy or intent to become pregnant during study follow up 16. Patient is participating in another trial that may influence the results of this study \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause Mortality | 30 days post-implant | Kaplan-Meier estimate of 30-day all-cause mortality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | 1, 6 and 12 months | The combined safety endpoint is defined as a composite of: * All-cause mortality * All stroke * Life-threatening bleeding * Acute kidney injury-Stage 3 (including renal replacement therapy) * Coronary artery obstruction requiring intervention * Major vascular complication * Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR) * High degree AV block requiring permanent pacemaker implantation |
Countries
Czechia, France, Germany, Italy, Netherlands, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled All subjects enrolled in the trial | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 18 |
| Overall Study | Not willing to attend 1-year visit | 2 |
| Overall Study | Screening failure | 5 |
| Overall Study | Valve explanted | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | All Enrolled |
|---|---|
| Age, Continuous | 81.9 years STANDARD_DEVIATION 5.9 |
| Region of Enrollment Czech Republic | 20 participants |
| Region of Enrollment France | 15 participants |
| Region of Enrollment Germany | 7 participants |
| Region of Enrollment Italy | 33 participants |
| Region of Enrollment Netherlands | 18 participants |
| Region of Enrollment United Kingdom | 7 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 16 / 92 |
| other Total, other adverse events | 68 / 92 |
| serious Total, serious adverse events | 72 / 92 |
Outcome results
Primary
All-cause Mortality
Kaplan-Meier estimate of 30-day all-cause mortality.
Time frame: 30 days post-implant
Population: all subjects who underwent an attempted implant of whom all were implanted with the CoreValve device via the direct aortic approach
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Implanted Population | All-cause Mortality | 4.4 Percentage of subjects |
Secondary
Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
The combined safety endpoint is defined as a composite of: * All-cause mortality * All stroke * Life-threatening bleeding * Acute kidney injury-Stage 3 (including renal replacement therapy) * Coronary artery obstruction requiring intervention * Major vascular complication * Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR) * High degree AV block requiring permanent pacemaker implantation
Time frame: 1, 6 and 12 months
Population: all subjects who underwent an attempted implant of whom all were implanted with the CoreValve device via the direct aortic approach
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Implanted Population | Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | 1 month | 7.6 Percentage of subjects |
| Implanted Population | Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | 6 months | 17.6 Percentage of subjects |
| Implanted Population | Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | 12 months | 19.9 Percentage of subjects |