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The objective of this data-collection study is to retrospectively evaluate the safety and clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment of a failed aortic surgical bioprosthetic valve in patients who are considered at increased surgical risk for a redo surgical aortic valve replacement.
Two options currently exist to treat failed surgical aortic bioprostheses: transcatheter valve-in-valve implantation (ViV) or redo surgical aortic valve replacement (rAVR). The objective of this comprehensive data-collection study is to retrospectively evaluate the safety and clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment of a failed aortic surgical bioprosthetic valve in patients who are considered at increased surgical risk for a redo surgical aortic valve replacement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Analysis Population | The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). |
| |
| Exploratory Registry Arm | The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of <19 mm or >27 mm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Aortic Valve Replacement | Device | Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint: The Rate of All-cause Mortality, Disabling Stroke, Life-threatening Bleeding Requiring Blood Transfusion, Acute Kidney Injury (AKI) Requiring Dialysis, and Major Vascular Complication. | Composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury (AKI) requiring dialysis, and major vascular complications | 30 days post index procedure |
| Primary Performance Endpoint: Rate of All-cause Mortality or Disabling Stroke. | Composite of all-cause mortality or disabling stroke. | 1 year post index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Procedural Success | Defined as absence of procedural mortality AND successful access, delivery of the valve, and retrieval of the delivery system | Procedure |
| Evaluation of Adverse Event Rates (Descriptive Endpoint) |
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Inclusion Criteria:
Exclusion Criteria:
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Study may enroll up to 100 patients who had a documented failed surgical aortic bioprosthetic valve (due stenosis, insufficiency, or a combination of both) at increased risk for redo surgical aortic valve replacement surgery. Patients must have met the sizing requirements of the Portico transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Patients must meet all inclusion and exclusion criteria to be eligible for enrollment.
In addition, an exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of <19 mm or >27 mm. There will be no enrollment limit in the exploratory registry arm
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| Name | Affiliation | Role |
|---|---|---|
| Barathi Sethuraman | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GenesisCare - St Andrew's Hospital & GenesisCare Leabrook - Satellite Site of GenesisCare - Wesley Hospital | Adelaide | Australia | ||||
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A total 6 clinical sites from four countries enrolled a total of 71 subjects between October, 2021 and September, 2023. Subjects were enrolled to two cohorts: the Primary Cohort enrolled subjects with a surgical bioprosthesis true inner diameter (ID) between 19 mm and 27 mm, while the Exploratory Cohort enrolled subjects with a true ID outside that range.
Once enrolled, subjects completed follow up visits at 30 days, 1-year, and annually through five years.
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| ID | Title | Description |
|---|---|---|
| FG000 | Primary Analysis Population | The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement |
| FG001 | Exploratory Registry Arm | The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of <19 mm or >27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary Analysis Population | The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The age for one subject not available. |
| 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 | Primary Safety Endpoint: The Rate of All-cause Mortality, Disabling Stroke, Life-threatening Bleeding Requiring Blood Transfusion, Acute Kidney Injury (AKI) Requiring Dialysis, and Major Vascular Complication. | Composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury (AKI) requiring dialysis, and major vascular complications | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | No | 30 days post index procedure |
|
5 years
Number of subjects as presented in the CSR does not limit the number of times a subject can be counted for another event.
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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 | Primary Analysis Population | The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm). Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karine Miquel | Abbott | +32 479 600 107 | karine.miquel@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 3, 2021 | Nov 6, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 30, 2022 | Jun 27, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D001022 | Aortic Valve Insufficiency |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), Transient Ischemic Attacks (TIA), Myocardial infarction (MI), Coronary obstruction, Minor, Major, and life-threatening bleeding, major vascular complication, access-related non-vascular complication, or cardiac structure complication, acute kidney injury (AKI) stages 1-4, Endocarditis, Clinically significant valve thrombosis.
| 30 days post index procedure |
| Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), Transient Ischemic Attacks (TIA), Myocardial infarction (MI), Coronary obstruction, Endocarditis, Clinically significant valve thrombosis. | 1 year post index procedure |
| Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA | 2 years post index procedure |
| Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA | 3 years post index procedure |
| Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA | 4 years post index procedure |
| Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA | 5 years post index procedure |
| Assessment of Clinical Benefit Endpoint - NYHA Class | Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications. | 30 days post index procedure |
| Assessment of Clinical Benefit Endpoint - NYHA Class | Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications. | 1 year post index procedure |
| Assessment of Clinical Benefit Endpoint - NYHA Class | Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications. | 2 years post index procedure |
| Assessment of Clinical Benefit Endpoint - NYHA Class | Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications. | 3 years post index procedure |
| Assessment of Clinical Benefit Endpoint - NYHA Class | Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications. | 4 years post index procedure |
| Assessment of Clinical Benefit Endpoint - NYHA Class | Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications. | 5 years post index procedure |
| Paravalvular Leak as Measured by Core Lab Echocardiography | Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe. | 30 Days |
| Paravalvular Leak as Measured by Core Lab Echocardiography | Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe. | 1 Year |
| Paravalvular Leak as Measured by Core Lab Echocardiography | Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe. | 2 Years |
| Paravalvular Leak as Measured by Core Lab Echocardiography | Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe. | 3 Years |
| Paravalvular Leak as Measured by Core Lab Echocardiography | Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe. | 4 Years |
| Paravalvular Leak as Measured by Core Lab Echocardiography | Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe. | 5 Years |
| Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | 30 days |
| Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | 1 year |
| Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | 2 Years |
| Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | 3 Years |
| Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | 4 Years |
| Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | 5 Years |
| Aortic Valve Area as Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | 30 days |
| Aortic Valve Area as Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | 1 Year |
| Aortic Valve Area as Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | 2 Years |
| Aortic Valve Area Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | 3 Years |
| Aortic Valve Area as Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | 4 Years |
| Aortic Valve Area as Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | 5 Years |
| New Pacemaker Implant | New permanent pacemaker implantation(PPI), with precision of the indication and the number of days postimplant of the placement of the new permanent pacemaker. | 30 days |
| New Pacemaker Implant | New permanent pacemaker implantation(PPI), with precision of the indication and the number of days postimplant of the placement of the new permanent pacemaker. | 1 year |
| GenesisCare - Wesley Hospital |
| Auchenflower |
| QLD 4066 |
| Australia |
| Rigshospitalet | Copenhagen | Denmark |
| Kerckhoff-Klinik gGmbH | Bad Nauheim | Germany |
| Universitätsklinikum Rostock (AöR) | Rostock | Germany |
| St. Bartholomew's Hospital | London | EC1A 7BE | United Kingdom |
| Morriston Hospital - ABM University Health Board | Morriston | United Kingdom |
| Death |
|
| Protocol Violation |
|
| BG001 | Exploratory Registry Arm | The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of <19 mm or >27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ejection Fraction | Mean | Standard Deviation | percent (%) |
|
| OG001 | Exploratory Registry Arm | The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of <19 mm or >27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement |
|
|
| Primary | Primary Performance Endpoint: Rate of All-cause Mortality or Disabling Stroke. | Composite of all-cause mortality or disabling stroke. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | No | 1 year post index procedure |
|
|
|
| Secondary | Number of Participants With Procedural Success | Defined as absence of procedural mortality AND successful access, delivery of the valve, and retrieval of the delivery system | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | No | Procedure |
|
|
|
| Secondary | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), Transient Ischemic Attacks (TIA), Myocardial infarction (MI), Coronary obstruction, Minor, Major, and life-threatening bleeding, major vascular complication, access-related non-vascular complication, or cardiac structure complication, acute kidney injury (AKI) stages 1-4, Endocarditis, Clinically significant valve thrombosis. | All values provided have been rounded to the nearest tenth decimal place. | Posted | Number | percent | 30 days post index procedure |
|
|
|
| Secondary | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), Transient Ischemic Attacks (TIA), Myocardial infarction (MI), Coronary obstruction, Endocarditis, Clinically significant valve thrombosis. | Event rates for 1-year follow up and beyond are presented as Kaplan-Meier rates and may not correspond to whole numbers of patients. | Posted | Number | percent | 1 year post index procedure |
|
|
|
| Secondary | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA | Event rates for 1-year follow up and beyond are presented as Kaplan-Meier rates and may not correspond to whole numbers of patients. | Posted | Number | percent | 2 years post index procedure |
|
|
|
| Secondary | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA | Event rates for 1-year follow up and beyond are presented as Kaplan-Meier rates and may not correspond to whole numbers of patients. | Posted | Number | percent | 3 years post index procedure |
|
|
|
| Secondary | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA | Event rates for 1-year follow up and beyond are presented as Kaplan-Meier rates and may not correspond to whole numbers of patients. | Posted | Number | percent | 4 years post index procedure |
|
|
|
| Secondary | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA | Event rates for 1-year follow up and beyond are presented as Kaplan-Meier rates and may not correspond to whole numbers of patients. | Posted | Number | percent | 5 years post index procedure |
|
|
|
| Secondary | Assessment of Clinical Benefit Endpoint - NYHA Class | Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | percent | 30 days post index procedure |
|
|
|
| Secondary | Assessment of Clinical Benefit Endpoint - NYHA Class | Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications. | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Number | percent | 1 year post index procedure |
|
|
|
| Secondary | Assessment of Clinical Benefit Endpoint - NYHA Class | Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | percent | 2 years post index procedure |
|
|
|
| Secondary | Assessment of Clinical Benefit Endpoint - NYHA Class | Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | percent | 3 years post index procedure |
|
|
|
| Secondary | Assessment of Clinical Benefit Endpoint - NYHA Class | Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | percent | 4 years post index procedure |
|
|
|
| Secondary | Assessment of Clinical Benefit Endpoint - NYHA Class | Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Number | percent | 5 years post index procedure |
|
|
|
| Secondary | Paravalvular Leak as Measured by Core Lab Echocardiography | Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | No | 30 Days |
|
|
|
| Secondary | Paravalvular Leak as Measured by Core Lab Echocardiography | Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | No | 1 Year |
|
|
|
| Secondary | Paravalvular Leak as Measured by Core Lab Echocardiography | Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | No | 2 Years |
|
|
|
| Secondary | Paravalvular Leak as Measured by Core Lab Echocardiography | Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | No | 3 Years |
|
|
|
| Secondary | Paravalvular Leak as Measured by Core Lab Echocardiography | Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | No | 4 Years |
|
|
|
| Secondary | Paravalvular Leak as Measured by Core Lab Echocardiography | Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | No | 5 Years |
|
|
|
| Secondary | Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | mmHg | 30 days |
|
|
|
| Secondary | Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | mmHg | 1 year |
|
|
|
| Secondary | Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | mmHg | 2 Years |
|
|
|
| Secondary | Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | mmHg | 3 Years |
|
|
|
| Secondary | Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | mmHg | 4 Years |
|
|
|
| Secondary | Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | mmHg | 5 Years |
|
|
|
| Secondary | Aortic Valve Area as Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | cm^2 | 30 days |
|
|
|
| Secondary | Aortic Valve Area as Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | cm^2 | 1 Year |
|
|
|
| Secondary | Aortic Valve Area as Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | cm^2 | 2 Years |
|
|
|
| Secondary | Aortic Valve Area Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | cm^2 | 3 Years |
|
|
|
| Secondary | Aortic Valve Area as Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | cm^2 | 4 Years |
|
|
|
| Secondary | Aortic Valve Area as Measured by Core Lab Echocardiography | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | cm^2 | 5 Years |
|
|
|
| Secondary | New Pacemaker Implant | New permanent pacemaker implantation(PPI), with precision of the indication and the number of days postimplant of the placement of the new permanent pacemaker. | Pacemaker implant (PPI) is unique and only applies to a portion of the patients. | Posted | Number | percent | 30 days |
|
|
|
| Secondary | New Pacemaker Implant | New permanent pacemaker implantation(PPI), with precision of the indication and the number of days postimplant of the placement of the new permanent pacemaker. | Pacemaker implant (PPI) is unique and only applies to a portion of the patients. | Posted | Number | percent | 1 year |
|
|
|
| 16 |
| 57 |
| 44 |
| 57 |
| 41 |
| 57 |
| EG001 | Exploratory Registry Arm | The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of <19 mm or >27 mm. Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement | 2 | 14 | 10 | 14 | 7 | 14 |
| Arrhythmia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Atrial Flutter | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Atrioventricular Block Complete | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Atrioventricular Block Second Degree | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiac Tamponade | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Mitral Valve Incompetence | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| General Physical Health Deterioration | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Incarcerated Hernia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Paravalvular Regurgitation | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hepatic Failure | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Covid-19 | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Vascular Access Complication | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Vascular Access Site Haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Vascular Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Hemoglobin Decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Esophageal Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Glioblastoma Multiforme | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cognitive Disorder | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Peripheral Artery Aneurysm | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Peripheral Artery Occlusion | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Thrombosis | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Device Dislocation | Product Issues | MedDRA 11.0 | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Iliac Artery Rupture | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Bundle Branch Block Left | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Left Ventricular Dysfunction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pericardial Effusion | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dental Caries | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Covid-19 | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Postoperative Delirium | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Vascular Access Site Haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Limb Discomfort | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Transient Ischaemic Attack | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sleep Apnea Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hematoma | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Ischaemia | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Intravascular Hemolysis | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Atrial Flutter | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Left Ventricular Failure | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Herpes Zoster | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Blood Potassium | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Myeloproliferative Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Neuropathy Peripheral | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Skin Irritation | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
The sponsor will have the right to publish overall study results. Investigators may publish results from their respective participating site per their discretion but only after the multi-center publication is published or 12 months have passed from the study conclusion without a multi-center publication.
| D014694 |
| Ventricular Outflow Obstruction |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| All stroke |
|
| Fatal stroke |
|
| Stroke with disability |
|
| Stroke without disability |
|
| TIA |
|
| Endocarditis |
|
| Clinically significant valve thrombosis |
|
| Stage 1 AKI |
|
| Stage 2 AKI |
|
| Stage 3 AKI |
|
| Stage 4 AKI |
|
| Type 1 Bleeding |
|
| Type 2 Bleeding |
|
| Type 3 Bleeding |
|
| Type 4 Bleeding |
|
| Major Vascular Complication |
|
| Major access-related non-vascular complication |
|
| Major cardiac structure complication |
|
| Myocardial infarction |
|
| Coronary obstruction |
|
| All stroke |
|
| Fatal stroke |
|
| Stroke with disability |
|
| Stroke without disability |
|
| TIA |
|
| Endocarditis |
|
| Clinically significant valve thrombosis |
|
| Myocardial infarction |
|
| Coronary obstruction |
|
| All stroke |
|
| Fatal stroke |
|
| Stroke with disability |
|
| Stroke without disability |
|
| TIA |
|
| Endocarditis |
|
| Clinically significant valve thrombosis |
|
| All stroke |
|
| Fatal stroke |
|
| Stroke with disability |
|
| Stroke without disability |
|
| TIA |
|
| Endocarditis |
|
| Clinically significant valve thrombosis |
|
| All stroke |
|
| Fatal stroke |
|
| Stroke with disability |
|
| Stroke without disability |
|
| TIA |
|
| Endocarditis |
|
| Clinically significant valve thrombosis |
|
| All stroke |
|
| Fatal stroke |
|
| Stroke with disability |
|
| Stroke without disability |
|
| TIA |
|
| Endocarditis |
|
| Clinically significant valve thrombosis |
|
| Class III |
|
| Class IV |
|
| Class III |
|
| Class IV |
|
| Class III |
|
| Class IV |
|
| Class III |
|
| Class IV |
|
| Class III |
|
| Class IV |
|
| Class III |
|
| Class IV |
|
| Mild |
|
|
| Moderate |
|
|
| Severe |
|
|
| Mild |
|
|
| Moderate |
|
|
| Severe |
|
|
| Mild |
|
|
| Moderate |
|
|
| Severe |
|
|
| Mild |
|
|
| Moderate |
|
|
| Severe |
|
|
| Mild |
|
|
| Moderate |
|
|
| Severe |
|
|
| Mild |
|
|
| Moderate |
|
|
| Severe |
|
|