Aortic Valve Stenosis
Conditions
Brief summary
The study objective is to evaluate safety and efficacy of the Medtronic TAVR (Transcatheter Aortic Valve Replacement) 2.0 system in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement
Detailed description
Prospective, single arm, multi-site study. Patients will be seen at pre and post procedure, discharge, 30 days, 6 months, 1 year, and annually up to 5 years.
Interventions
DEVICEMedtronic Transcatheter Aortic Valve 2.0 Replacement System
Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.
Sponsors
Medtronic Cardiovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Severe aortic stenosis, defined as aortic valve area of \<1.0 cm2 (or aortic valve area index of \<0.6 cm2/m2) by the continuity equation, AND mean gradient \>40 mmHg OR maximal aortic valve velocity \>4.0 m/sec by resting echocardiogram 2. Society of Thoracic Surgeons(STS) score of ≥8 OR documented heart team agreement of ≥ high risk for aortic valve replacement due to frailty or co-morbidities 3. Symptoms of aortic stenosis AND New York Heart Association (NYHA) Functional Class II or greater 4. The subject and the treating physician agree that the subject will return for all required post procedure follow-up visits.
Exclusion criteria
1. Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve) 2. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre medicated: * aspirin or heparin (HIT/HITTS) and bivalirudin * ticlopidine and clopidogrel * nitinol (titanium or nickel) * contrast media 3. Blood dyscrasias as defined: leukopenia (WBC \<1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states 4. Untreated clinically significant coronary artery disease requiring revascularization 5. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \<20% by echocardiography, contrast ventriculography, or radionuclide ventriculography 6. End stage renal disease requiring chronic dialysis or creatinine clearance \<20 cc/min. 7. Ongoing sepsis, including active endocarditis 8. Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to study procedure 9. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment 10. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support 11. Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA) 12. Gastrointestinal (GI) bleeding that would preclude anticoagulation 13. Subject refuses a blood transfusion 14. Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits) 15. Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions 16. Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams 17. Currently participating in an investigational drug or another device study (excluding registries) 18. Evidence of an acute myocardial infarction ≤30 days before the study procedure 19. Need for emergency surgery for any reason 20. Liver failure (Child-Pugh class C) 21. Subject is pregnant or breast feeding 22. Pre existing prosthetic heart valve in any position 23. Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation) 24. Severe mitral regurgitation 25. Severe tricuspid regurgitation 26. Moderate or severe mitral stenosis 27. Hypertrophic obstructive cardiomyopathy 28. Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus, or vegetation 29. Congenital bicuspid or unicuspid valve verified by echocardiography 30. Access vessel diameter \<5.5 mm or \<6.0 mm for patent left internal mammary artery (LIMA)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause Mortality Rate | 30 days |
| Stroke (Disabling) Rate | 30 days |
| The Percentage of Subjects With None or Trace Prosthetic Regurgitation on Echocardiogram | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Coronary Artery Obstruction | 30 days | Percentage of participants with coronary artery obstruction - VARC-II definitions |
| Percentage of Patient With Acute Kidney Injury- Stage 2 or 3 | 30 days | Percentage of participants with Acute kidney injury - Stage 2 or 3 - VARC-II definitions |
| Percentage of Participants With Valve-related Dysfunction Requiring Repeat Procedure | 30 days | Percentage of participants with valve-related dysfunction requiring repeat procedure - VARC-II definition |
| Event Rate of the VARC II Combined Safety Endpoint at 30 Days, Which Includes the Following Components: | 30 days | 1. All-cause mortality \> 2. All stroke (disabling and non-disabling) \> 3. Life-threatening bleeding \> 4. Acute kidney injury: stage 2 or 3 (including renal replacement therapy) \> 5. Coronary artery obstruction requiring intervention \> 6. Major vascular complication \> 7. Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR) |
| Hemodynamic Performance - Aortic Valve Area | 30 days | Aortic Valve Area (cm2) by transthoracic echocardiogram |
| Hemodynamic Performance - Mean Gradient | 30 days | Mean gradient (mmHg) by transthoracic echocardiogram |
| Hemodynamic Performance - Total Prosthetic Regurgitation Graded as None/Trace | 30 days | Total prosthetic regurgitation by transthoracic echocardiogram |
| Device Success Rate (VARC II) | 24 hours to 7 days | — |
| Percentage of Participants With Life Threatening or Disabling Bleeding | 30 days | Percentage of participants with life threatening or disabling bleeding - VARC-II definitions |
| Percentage of Participants With Major Vascular Complication | 30 days | Percentage of participants with major vascular complication - VARC-II definition |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Medtronic Transcatheter Aortic Valve 2.0 Replacement System Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System
Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement. | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 1 Month | Death | 2 |
| 1 Year | Death | 6 |
| 1 Year | Withdrawal by Subject | 1 |
| 2 Year | Death | 2 |
| 2 Year | Lost to Follow-up | 1 |
| 3 Year | Death | 2 |
| 3 Year | Withdrawal by Subject | 1 |
| 4 Year | Death | 9 |
| 5 Year | Lost to Follow-up | 4 |
| 6 Month | Death | 4 |
| 6 Month | Withdrawal by Subject | 2 |
| Enrollment | Inclusion/Exclusion not met | 21 |
| Enrollment | Study Enrollment Closed | 3 |
| Enrollment | Subject treated with commercially available device | 6 |
| Enrollment | Withdrawal by Subject | 3 |
| Procedure | Death | 1 |
Baseline characteristics
| Characteristic | Medtronic Transcatheter Aortic Valve 2.0 Replacement System | — |
|---|---|---|
| Age, Continuous | 83.3 years STANDARD_DEVIATION 7.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 60 Participants | — |
| Sex: Female, Male Female | 39 Participants | — |
| Sex: Female, Male Male | 21 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 26 / 60 |
| other Total, other adverse events | 38 / 60 |
| serious Total, serious adverse events | 39 / 60 |
Outcome results
Primary
All-cause Mortality Rate
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic Transcatheter Aortic Valve 2.0 Replacement System | All-cause Mortality Rate | 1.7 percentage of participants |
Primary
Stroke (Disabling) Rate
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic Transcatheter Aortic Valve 2.0 Replacement System | Stroke (Disabling) Rate | 1.7 percentage of participants |
Primary
The Percentage of Subjects With None or Trace Prosthetic Regurgitation on Echocardiogram
Time frame: 30 days
Population: Only subjects with transthoracic echo (TTE) could be analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic Transcatheter Aortic Valve 2.0 Replacement System | The Percentage of Subjects With None or Trace Prosthetic Regurgitation on Echocardiogram | 72.4 percentage of participants |
Secondary
Device Success Rate (VARC II)
Time frame: 24 hours to 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic Transcatheter Aortic Valve 2.0 Replacement System | Device Success Rate (VARC II) | 80.8 percentage of participants |
Secondary
Event Rate of the VARC II Combined Safety Endpoint at 30 Days, Which Includes the Following Components:
1. All-cause mortality \> 2. All stroke (disabling and non-disabling) \> 3. Life-threatening bleeding \> 4. Acute kidney injury: stage 2 or 3 (including renal replacement therapy) \> 5. Coronary artery obstruction requiring intervention \> 6. Major vascular complication \> 7. Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic Transcatheter Aortic Valve 2.0 Replacement System | Event Rate of the VARC II Combined Safety Endpoint at 30 Days, Which Includes the Following Components: | 15.0 percentage of participants |
Secondary
Hemodynamic Performance - Aortic Valve Area
Aortic Valve Area (cm2) by transthoracic echocardiogram
Time frame: 30 days
Population: Only subjects with TTE could be analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medtronic Transcatheter Aortic Valve 2.0 Replacement System | Hemodynamic Performance - Aortic Valve Area | 2.0 cm2 | Standard Deviation 0.5 |
Secondary
Hemodynamic Performance - Mean Gradient
Mean gradient (mmHg) by transthoracic echocardiogram
Time frame: 30 days
Population: Only subjects with TTE could be analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medtronic Transcatheter Aortic Valve 2.0 Replacement System | Hemodynamic Performance - Mean Gradient | 6.4 mmHg | Standard Deviation 2.1 |
Secondary
Hemodynamic Performance - Total Prosthetic Regurgitation Graded as None/Trace
Total prosthetic regurgitation by transthoracic echocardiogram
Time frame: 30 days
Population: Only subjects with TTE could be analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic Transcatheter Aortic Valve 2.0 Replacement System | Hemodynamic Performance - Total Prosthetic Regurgitation Graded as None/Trace | 72.4 percentage of participants |
Secondary
Percentage of Participants With Coronary Artery Obstruction
Percentage of participants with coronary artery obstruction - VARC-II definitions
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic Transcatheter Aortic Valve 2.0 Replacement System | Percentage of Participants With Coronary Artery Obstruction | 0.0 percentage of participants |
Secondary
Percentage of Participants With Life Threatening or Disabling Bleeding
Percentage of participants with life threatening or disabling bleeding - VARC-II definitions
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic Transcatheter Aortic Valve 2.0 Replacement System | Percentage of Participants With Life Threatening or Disabling Bleeding | 11.7 percentage of participants |
Secondary
Percentage of Participants With Major Vascular Complication
Percentage of participants with major vascular complication - VARC-II definition
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic Transcatheter Aortic Valve 2.0 Replacement System | Percentage of Participants With Major Vascular Complication | 10.0 percentage of participants |
Secondary
Percentage of Participants With Valve-related Dysfunction Requiring Repeat Procedure
Percentage of participants with valve-related dysfunction requiring repeat procedure - VARC-II definition
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic Transcatheter Aortic Valve 2.0 Replacement System | Percentage of Participants With Valve-related Dysfunction Requiring Repeat Procedure | 0.0 percentage of participants |
Secondary
Percentage of Patient With Acute Kidney Injury- Stage 2 or 3
Percentage of participants with Acute kidney injury - Stage 2 or 3 - VARC-II definitions
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic Transcatheter Aortic Valve 2.0 Replacement System | Percentage of Patient With Acute Kidney Injury- Stage 2 or 3 | 1.7 percentage of participants |