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The study objectives are to assess the safety and efficacy of the CoreValve Evolut 34R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis who are considered at high or extreme risk for surgical aortic valve replacement.
This objective will be accomplished by a prospective, single arm, historical controlled, multi-site study involving up to 60 implanted subjects at up to 15 study sites in the United States. Procedural and 30 day safety and efficacy results from this study will be compared to appropriate historical control data for the Medtronic CoreValve System. Subjects will be followed up to 5 years following implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoreValve Evolut 34R TAVR system | Experimental | Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoreValve Evolut 34R TAVR system | Device | The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With All-cause Mortality | Percentage of participants with all-cause mortality at 30 days | 30 Days |
| Percentage of Participants With Stroke (Disabling) | Percentage of participants with disabling stroke (VARC-II definitions) at 30 days | 30 Days |
| Device Success Rate | Device Success defined as:
| 24 hours to 7 days post implantation |
| The Percentage of Subjects With no More Than Mild Prosthetic Regurgitation at Early Post Procedure Echocardiogram | The percentage of subjects with no more than mild prosthetic regurgitation at early post procedure echocardiogram as assessed by echo core laboratory | 24 hours to 7 days post implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With VARC II Combined Safety Endpoint Event at 30 Days | VARC II composite safety endpoint includes the following components:
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Inclusion Criteria:
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.
Subjects with low-flow/low gradient severe aortic stenosis can be included, provided low-dose dobutamine or exercise stress echocardiography demonstrates a mean gradient of > 40 mmHg or a maximal aortic valve velocity of > 4.0 m/sec, AND aortic valve area of < 1.0 cm2 (or aortic valve area index of < 0.6 cm2/m2).
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.
Symptoms of aortic stenosis, AND New York Heart Association (NYHA) Functional Class II or greater.
The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
Exclusion Criteria:
Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. subject is indicated for mechanical prosthetic valve).
A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:
Blood dyscrasias as defined: leukopenia (WBC < 1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
Untreated clinically significant coronary artery disease requiring revascularization.
Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.
End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min.
Ongoing sepsis, including active endocarditis.
Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to study procedure.
Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment.
Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
Gastrointestinal (GI) bleeding that would preclude anticoagulation.
Subject refuses a blood transfusion.
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).
Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions.
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-ups exams.
Currently participating in an investigational drug or another device study (excluding registries).
Evidence of an acute myocardial infarction ≤ 30 days before the study procedure.
Need for emergency surgery for any reason.
Liver failure (Child-Pugh class C).
Subject is pregnant or breast feeding.
Anatomical exclusion criteria:
Pre-existing prosthetic heart valve in any position.
Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation).
Severe mitral regurgitation.
Severe tricuspid regurgitation.
Moderate or severe mitral stenosis.
Hypertrophic obstructive cardiomyopathy.
Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus, or vegetation.
Congenital bicuspid or unicuspid valve verified by echocardiography.
For transfemoral or transaxillary (subclavian) access:
Access vessel diameter < 5.5 mm or <6.0 mm for patent left internal mammary artery (LIMA)
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| Name | Affiliation | Role |
|---|---|---|
| Mathew R Williams, MD | NYU Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | United States | ||
| Beth Israel Deaconess Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | CoreValve Evolut R TAVR System 34R Valve | The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:
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| 36-Month |
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| 48-Month |
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| 60-Month |
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| ID | Title | Description |
|---|---|---|
| BG000 | CoreValve Evolut 34R TAVR System | Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.> > CoreValve Evolut 34R TAVR system: The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:>
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| Units | Counts |
|---|---|
| Participants |
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| 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 | Percentage of Participants With All-cause Mortality | Percentage of participants with all-cause mortality at 30 days | Posted | Number | 95% Confidence Interval | percentage of participants | 30 Days |
|
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All events 6 months, All Cause Mortality 60 months
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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 | EVOLUTR 34R | Participants implanted with EVOLUTR 34R device | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phuong-Uyen Le | Medtronic | 763-526-0989 | phuong-uyen.n.le@medtronic.com |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 30 days post-implantation |
| Percentage of Participants With Life Threatening or Disabling Bleeding | Percentage of participants with life threatening or disabling bleeding - see VARC-2 definitions for classification details | 30 days post-implantation |
| Percentage of Participants With Major Vascular Complication | Percentage of participants with Major vascular complication - see VARC-2 definitions for additional details | 30 days |
| Percentage of Participants With Acute Kidney Injury: Stage 2 or 3 | Percentage of participants with Acute Kidney Injury: Stage 2 or 3 - see VARC-2 definitions for additional details | 30 days |
| Percentage of Participants With Coronary Artery Obstruction | Percentage of participants with coronary artery obstruction - see VARC-2 definitions for additional details | 30 days |
| Percentage of Subjects With Valve-related Dysfunction Requiring Repeat Procedure | Percentage of subjects with valve-related dysfunction requiring repeat procedure - see VARC-2 definitions for additional details | 30 days |
| Percentage of Subjects With Permanent Pacemaker Implant at 30 Days | Percentage of subjects with new permanent pacemaker implant at 30 days. | 30 days |
| Percentage of Resheath and Recapture Success | Successful resheathing is defined as Evolut R TAV (including frame) was resheathed into the capsule of the delivery cathether to the desired amount intended, as verified by fluoroscopy. Successful recapture is defined as the entire Evolut R TAV (including frame) is resheathed into the capsule of the delivery catheter until there is no gap between the capsule and the tip, as verified by fluoroscopy. | Implant procedure |
| Hemodynamic Performance Metrics - Mean Gradient | Mean gradient (mmHg) as measured by transthoracic echocardiogram and assessed by echo core laboratory | 30 days |
| Hemodynamic Performance Metrics- Aortic Valve Area | Aortic valve area as measured by transthoracic echocardiogram and assessed by echo core laboratory | 30 Days |
| Hemodynamic Performance Metrics - Total Prosthetic Regurgitation Graded as None/Trace | Total prosthetic regurgitation (none/trace) as measured by transthoracic echocardiogram and assessed by echo core laboratory | 30 days |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| University of Michigan Health Systems | Ann Arbor | Michigan | 48109 | United States |
| Spectrum Health Hospitals | Grand Rapids | Michigan | 49503 | United States |
| New York Langone Medical Center | New York | New York | 10016 | United States |
| St. Francis Hospital | Roslyn | New York | 11576 | United States |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States |
| Pinnacle Health/Moffitt Heart and Vascular Institute | Harrisburg | Pennsylvania | 17104 | United States |
| Baylor Heart and Vascular Hospital | Dallas | Texas | 75225 | United States |
| Aurora Health Care/St Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Percentage of Participants With Stroke (Disabling) | Percentage of participants with disabling stroke (VARC-II definitions) at 30 days | Posted | Number | 95% Confidence Interval | percentage of participants | 30 Days |
|
|
|
| Primary | Device Success Rate | Device Success defined as:
| Posted | Number | 95% Confidence Interval | percentage of participants | 24 hours to 7 days post implantation |
|
|
|
| Primary | The Percentage of Subjects With no More Than Mild Prosthetic Regurgitation at Early Post Procedure Echocardiogram | The percentage of subjects with no more than mild prosthetic regurgitation at early post procedure echocardiogram as assessed by echo core laboratory | Posted | Number | 95% Confidence Interval | percentage of participants | 24 hours to 7 days post implantation |
|
|
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| Secondary | Percentage of Participants With VARC II Combined Safety Endpoint Event at 30 Days | VARC II composite safety endpoint includes the following components:
| Posted | Number | 95% Confidence Interval | percentage of participants | 30 days post-implantation |
|
|
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| Secondary | Percentage of Participants With Life Threatening or Disabling Bleeding | Percentage of participants with life threatening or disabling bleeding - see VARC-2 definitions for classification details | Posted | Number | 95% Confidence Interval | percentage of participants | 30 days post-implantation |
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| Secondary | Percentage of Participants With Major Vascular Complication | Percentage of participants with Major vascular complication - see VARC-2 definitions for additional details | Posted | Number | 95% Confidence Interval | percentage of participants | 30 days |
|
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| Secondary | Percentage of Participants With Acute Kidney Injury: Stage 2 or 3 | Percentage of participants with Acute Kidney Injury: Stage 2 or 3 - see VARC-2 definitions for additional details | Posted | Number | 95% Confidence Interval | percentage of participants | 30 days |
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| Secondary | Percentage of Participants With Coronary Artery Obstruction | Percentage of participants with coronary artery obstruction - see VARC-2 definitions for additional details | Posted | Number | 95% Confidence Interval | percentage of participants | 30 days |
|
|
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| Secondary | Percentage of Subjects With Valve-related Dysfunction Requiring Repeat Procedure | Percentage of subjects with valve-related dysfunction requiring repeat procedure - see VARC-2 definitions for additional details | Posted | Number | 95% Confidence Interval | percentage of participants | 30 days |
|
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| Secondary | Percentage of Subjects With Permanent Pacemaker Implant at 30 Days | Percentage of subjects with new permanent pacemaker implant at 30 days. | Subjects with pre-existing pacemaker or internal cardiac defibrillator were excluded from analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 30 days |
|
|
|
| Secondary | Percentage of Resheath and Recapture Success | Successful resheathing is defined as Evolut R TAV (including frame) was resheathed into the capsule of the delivery cathether to the desired amount intended, as verified by fluoroscopy. Successful recapture is defined as the entire Evolut R TAV (including frame) is resheathed into the capsule of the delivery catheter until there is no gap between the capsule and the tip, as verified by fluoroscopy. | Success could only be analyzed in subjects where the resheath/recapture feature was used. | Posted | Number | percentage of participants | Implant procedure |
|
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| Secondary | Hemodynamic Performance Metrics - Mean Gradient | Mean gradient (mmHg) as measured by transthoracic echocardiogram and assessed by echo core laboratory | Only participants with echo could be analyzed. | Posted | Mean | Standard Deviation | mmHg | 30 days |
|
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| Secondary | Hemodynamic Performance Metrics- Aortic Valve Area | Aortic valve area as measured by transthoracic echocardiogram and assessed by echo core laboratory | Only participants with echo could be analyzed. | Posted | Mean | Standard Deviation | cm2 | 30 Days |
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| Secondary | Hemodynamic Performance Metrics - Total Prosthetic Regurgitation Graded as None/Trace | Total prosthetic regurgitation (none/trace) as measured by transthoracic echocardiogram and assessed by echo core laboratory | Only participants with echo could be analyzed. | Posted | Number | percentage of participants | 30 days |
|
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| 60 |
| 34 |
| 60 |
| 48 |
| 60 |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Acute Myocardial Infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Atrioventricular Block | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Atrioventricular Block Complete | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Atrioventricular Block First Degree | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Bundle Branch Block Left | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Cardiac Arrest | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Cardiac Failure Acute | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Cardiogenic Shock | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Conduction Disorder | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Nodal Rhythm | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Pulseless Electrical Activity | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Supraventricular Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Ventricular Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Vision Blurred | Eye disorders | MedDRA 10.0 | Systematic Assessment |
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| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Chest Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Device Embolisation | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Generalised Oedema | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Viral Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Arterial Injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Compression Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Hip Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypoxic-Ischaemic Encephalopathy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Transient Ischaemic Attack | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Confusional State | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Glomerulonephritis Membranous | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Femoral Artery Dissection | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Peripheral Ischaemia | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| All-Cause Mortality | General disorders | Non-systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Atrioventricular Block First Degree | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Bundle Branch Block Left | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Extrasystoles | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Sinus Bradycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Myocardial Necrosis Marker Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| D014694 |
| Ventricular Outflow Obstruction |