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Reevaluation of clinical strategy in this patient population led to a business decision to discontinue the study. Discontinuation is not due to any patient safety, patient welfare, or quality issues.
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The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolutâ„¢ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.
Single-arm, descriptive, multi-center, international
All subjects will be treated with a Medtronic Evolutâ„¢ PRO+ TAVR System. Subject follow-ups will be conducted at pre and post-procedure, discharge, 30 days, 6 months, and annually through 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medtronic Evolutâ„¢ PRO+ System | Experimental | All study subjects will be treated with the Medtronic Evolutâ„¢ PRO+ TAVR System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic Evolutâ„¢ PRO+ System | Device | TAVR treatment with Medtronic Evolutâ„¢ PRO+ System |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause and Cardiovascular Mortality | Rate of all-cause and cardiovascular mortality | 30 days |
| All-cause and Cardiovascular Mortality | Rate of all-cause and cardiovascular mortality | 6 months |
| All Stroke (Disabling and Non-disabling) | Rate of disabling and non-disabling stroke | 30 days |
| All Stroke (Disabling and Non-disabling) | Rate of disabling and non-disabling stroke | 6 months |
| Myocardial Infarction (Periprocedural and Spontaneous) | Rate of periprocedural and spontaneous myocardial infarction | 30 days |
| Myocardial Infarction (Periprocedural and Spontaneous) | Rate of periprocedural and spontaneous myocardial infarction | 6 months |
| Acute Kidney Injury | Rate of acute kidney injury | 30 days |
| Acute Kidney Injury | Rate of acute kidney injury | 6 months |
| Major Vascular Complications |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| All-cause and Cardiovascular Mortality | Rate of all-cause and cardiovascular mortality | Annually through 5 years |
| All Stroke (Disabling and Non-disabling) | Rate of disabling and non-disabling strokes |
Key Inclusion Criteria:
Severe aortic stenosis, defined as: Aortic valve area ≤ 1.0 cm^2, or aortic valve area index ≤ 0.6 cm^2/m^2, and mean gradient ≥ 40 mmHg or Vmax ≥ 4.0 m/sec
Subject denies symptoms attributable to aortic stenosis, including but not limited to:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Sorajja, MD | Allina Health System | Principal Investigator |
| Josep Rodes-Cabau, MD | Fondation IUCPQ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Robles Hospital & Medical Center | Thousand Oaks | California | 91360 | United States | ||
| Northwell Health |
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| ID | Title | Description |
|---|---|---|
| FG000 | TAVR | Up to 75 subjects with moderate, symptomatic AS |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
No subject had an attempted TAVR procedure.
As full baseline data is only required for subjects who are approved for treatment it was not reported for all subjects. No subjects were approved for treatment. Of the 11 enrolled (consented) subjects 8 had baseline data reported.
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| ID | Title | Description |
|---|---|---|
| BG000 | TAVR | Up to 75 subjects with moderate, symptomatic AS with an attempted TAVR procedure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | All-cause and Cardiovascular Mortality | Rate of all-cause and cardiovascular mortality | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 30 days |
|
|
Adverse events (AEs) were collected from study enrollment (consent) through study exit, up to 151 days. First subject was enrolled on 28 May 2021 and last subject was exited on 28 Feb 2022. No study subjects were treated. If subjects had been treated all AEs would have been reported through 6 months post-procedure. After 6 months post-procedures only serious adverse events, device-related events, and device deficiencies would have been reported.
The definitions used for AEs and SAEs is too long for the field. The definitions differed in that the CIP used the definitions found in ISO14100:2020.
Investigators are required to evaluate and document in the subject's medical records all adverse events and device deficiencies observed in study subjects from the time they are enrolled until they are exited from the study. All AEs should be followed through their resolution.
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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 | TAVR | Up to 75 subjects with moderate, symptomatic AS with an attempted TAVR procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary stenosis | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Scalp laceration | Injury, poisoning and procedural complications | Systematic Assessment |
Early termination of the study prior to any attempted TAVR procedures led to no evaluable subjects for data analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Waltonen | Medtronic Structural Heart & Aortic | 763-526-0424 | robert.waltonen@medtronic.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 | Mar 9, 2021 | Jul 17, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 11, 2021 | Oct 12, 2023 | SAP_002.pdf |
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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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Rate of major vascular complications |
| 30 days |
| Major Vascular Complications | Rate of major vascular complications | 6 months |
| Life-threatening Bleed | Rate of life-threatening (or disabling) bleed | 30 days |
| Life-threatening Bleed | Rate of life-threatening (or disabling) bleed | 6 months |
| New Permanent Pacemaker Implantation (PPI) | Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline) | 30 days |
| New Permanent Pacemaker Implantation (PPI) | Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline) | 6 months |
| New Intraventricular Conduction Delays | Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline) | 30 days |
| New Intraventricular Conduction Delays | Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline) | 6 months |
| New-onset Atrial Fibrillation | Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline) | 30 days |
| New-onset Atrial Fibrillation | Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline) | 6 months |
| Valve-related Dysfunction Requiring Repeat Procedure | Rate of valve-related dysfunction requiring repeat procedure | 30 days |
| Valve-related Dysfunction Requiring Repeat Procedure | Rate of valve-related dysfunction requiring repeat procedure | 6 months |
| Device Success (VARC-2) | The VARC-2 definition of device success is absence of procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomical location, intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity <3 m/sec), and absence of moderate or severe prosthetic valve regurgitation | Discharge (12 hours to 7 days post-procedure) |
| Cardiovascular and Heart Failure Hospitalizations | Rate of cardiovascular and heart failure hospitalizations | 30 days |
| Cardiovascular and Heart Failure Hospitalizations | Rate of cardiovascular and heart failure hospitalizations | 6 months |
| Heart Failure Events | Rate of heart failure events | 30 days |
| Heart Failure Events | Rate of heart failure events | 6 months |
| Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient | Discharge (12 hours to 7 days post-procedure) |
| Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient | 30 days |
| Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient | 6 months |
| Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography | Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area. | Discharge (12 hours to 7 days post-procedure) |
| Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography | Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area. | 30 days |
| Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography | Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area. | 6 months |
| Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography | Discharge (12 hours to 7 days post-procedure) |
| Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography | 30 days |
| Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography | 6 months |
| Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography | Discharge (12 hours to 7 days post-procedure) |
| Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography | 30 days |
| Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography | 6 months |
| Change From Baseline in New York Heart Association (NYHA) Functional Classification | Reporting of NYHA classification change from baseline to 30 days and 6 months NYHA Classification criteria: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. | 30 days and 6 months |
| Change From Baseline in Six-minute Walk Test (6MWT) | Reporting change from baseline in distance walked during 6MWT | 6 months |
| Change From Baseline in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) | KCCQ quantifies physical function, symptoms, social function, self-efficiency, knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. | 30 days and 6 months |
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Reporting of change in left ventricular ejection fraction (LVEF) from baseline by echocardiography | 6 months |
| Change From Baseline in Global Longitudinal Strain (GLS) | Reporting of change in GLS from baseline by echocardiography | 6 months |
| Change From Baseline in Left Ventricular Filling Pressure (E:e') | Reporting of change in left ventricular filling pressure (E:e') from baseline by echocardiography | 6 months |
| Change From Baseline in Stroke Volume Index (SVI) | Reporting of change in stroke volume index (SVI) from baseline by echocardiography | 6 months |
| Change From Baseline in NT-pro B-type Natriuretic Peptide (NT-proBNP) | Reporting of change in NT-pro B-type natriuretic peptide (NT-proBNP) from baseline | 6 months |
| Annually through 5 years |
| Cardiovascular and Heart Failure Hospitalizations | Rate of cardiovascular and heart failure hospitalizations | Annually through 5 years |
| Heart Failure Events | Rate of heart failure events | Annually through 5 years |
| New York Heart Association (NYHA) Functional Classification | Reporting NYHA functional classification by timepoint following attempted procedure | 30 days, 6 months, and annually through 5 years |
| Change From Baseline in New York Heart Association (NYHA) Functional Classification | Reporting of NYHA classification change from baseline to 30 days and 6 months NYHA Classification criteria: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. | Annually through 5 years |
| Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) | KCCQ quantifies physical function, symptoms, social function, self-efficiency, knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. | Annually through 5 years |
| Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient | Annually through 5 years |
| Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by effective orifice area (EOA) | Annually through 5 years |
| Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular prosthetic regurgitation by Doppler echocardiography | Annually through 5 years |
| Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography | Annually through 5 years |
| Prosthetic Valve Thrombosis | Rate of prosthetic valve thrombosis | 30 days, 6 months, and annually through 5 years |
| Prosthetic Valve Endocarditis | Rate of prosthetic valve endocarditis | 30 days, 6 months, and annually through 5 years |
| Bioprosthetic Valve Dysfunction (BVD) | Rate of bioprosthetic valve dysfunction (BVD) | 30 days, 6 months, and annually through 5 years |
| Bioprosthetic Valve Failure (BVF) | Rate of bioprosthetic valve failure (BVF) | 30 days, 6 months, and annually through 5 years |
| Valve-related Dysfunction Requiring Repeat Procedure | Rate of valve-related dysfunction requiring repeat procedure | Annually through 5 years |
| Manhasset |
| New York |
| 11030-3816 |
| United States |
| UPMC Pinnacle Harrisburg Campus | Wormleysburg | Pennsylvania | 17043 | United States |
| Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| The Alfred Hospital | Melbourne | Australia |
| IUCPQ | Québec | G1V 4G5 | Canada |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| Waikato Hospital | Hamilton | New Zealand |
| Withdrawal by Subject |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| NYHA Classification | New York Heart Association (NYHA) Classification: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. | Count of Participants | Participants |
|
| Society of Thoracic Surgeons (STS) Score | Measure Description: Society of Thoracic Surgeons (STS) score of predicted risk of 30-day mortality following surgical aortic valve replacement. The score is measured as a percentage (0-100%) with higher scores representing a higher probability of mortality at 30 days. | STS score was reported for 6 participants | Mean | Full Range | Percentage |
|
| BSA | Body surface area reporting in meters squared | Body surface area was reported for 6 participants. | Mean | Full Range | m^2 |
|
| Primary | All-cause and Cardiovascular Mortality | Rate of all-cause and cardiovascular mortality | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 6 months |
|
|
| Primary | All Stroke (Disabling and Non-disabling) | Rate of disabling and non-disabling stroke | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 30 days |
|
|
| Primary | All Stroke (Disabling and Non-disabling) | Rate of disabling and non-disabling stroke | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 6 months |
|
|
| Primary | Myocardial Infarction (Periprocedural and Spontaneous) | Rate of periprocedural and spontaneous myocardial infarction | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 30 days |
|
|
| Primary | Myocardial Infarction (Periprocedural and Spontaneous) | Rate of periprocedural and spontaneous myocardial infarction | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 6 months |
|
|
| Primary | Acute Kidney Injury | Rate of acute kidney injury | No subjects with an attempted TAVR procedure No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 30 days |
|
|
| Primary | Acute Kidney Injury | Rate of acute kidney injury | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 6 months |
|
|
| Primary | Major Vascular Complications | Rate of major vascular complications | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 30 days |
|
|
| Primary | Major Vascular Complications | Rate of major vascular complications | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 6 months |
|
|
| Primary | Life-threatening Bleed | Rate of life-threatening (or disabling) bleed | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 30 days |
|
|
| Primary | Life-threatening Bleed | Rate of life-threatening (or disabling) bleed | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 6 months |
|
|
| Primary | New Permanent Pacemaker Implantation (PPI) | Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline) | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 30 days |
|
|
| Primary | New Permanent Pacemaker Implantation (PPI) | Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline) | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 6 months |
|
|
| Primary | New Intraventricular Conduction Delays | Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline) | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 30 days |
|
|
| Primary | New Intraventricular Conduction Delays | Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline) | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 6 months |
|
|
| Primary | New-onset Atrial Fibrillation | Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline) | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 30 days |
|
|
| Primary | New-onset Atrial Fibrillation | Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline) | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 6 months |
|
|
| Primary | Valve-related Dysfunction Requiring Repeat Procedure | Rate of valve-related dysfunction requiring repeat procedure | Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure. | Posted | 30 days |
|
|
| Primary | Valve-related Dysfunction Requiring Repeat Procedure | Rate of valve-related dysfunction requiring repeat procedure | Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure. | Posted | 6 months |
|
|
| Primary | Device Success (VARC-2) | The VARC-2 definition of device success is absence of procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomical location, intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity <3 m/sec), and absence of moderate or severe prosthetic valve regurgitation | Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure. | Posted | Discharge (12 hours to 7 days post-procedure) |
|
|
| Primary | Cardiovascular and Heart Failure Hospitalizations | Rate of cardiovascular and heart failure hospitalizations | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 30 days |
|
|
| Primary | Cardiovascular and Heart Failure Hospitalizations | Rate of cardiovascular and heart failure hospitalizations | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 6 months |
|
|
| Primary | Heart Failure Events | Rate of heart failure events | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 30 days |
|
|
| Primary | Heart Failure Events | Rate of heart failure events | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 6 months |
|
|
| Primary | Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | Discharge (12 hours to 7 days post-procedure) |
|
|
| Primary | Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 30 days |
|
|
| Primary | Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 6 months |
|
|
| Primary | Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography | Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area. | Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure. | Posted | Discharge (12 hours to 7 days post-procedure) |
|
|
| Primary | Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography | Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area. | Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure. | Posted | 30 days |
|
|
| Primary | Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography | Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area. | Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure. | Posted | 6 months |
|
|
| Primary | Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography | Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure. | Posted | Discharge (12 hours to 7 days post-procedure) |
|
|
| Primary | Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography | Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure. | Posted | 30 days |
|
|
| Primary | Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography | Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure. | Posted | 6 months |
|
|
| Primary | Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography | Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure. | Posted | Discharge (12 hours to 7 days post-procedure) |
|
|
| Primary | Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography | Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure. | Posted | 30 days |
|
|
| Primary | Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography | Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure. | Posted | 6 months |
|
|
| Primary | Change From Baseline in New York Heart Association (NYHA) Functional Classification | Reporting of NYHA classification change from baseline to 30 days and 6 months NYHA Classification criteria: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 30 days and 6 months |
|
|
| Primary | Change From Baseline in Six-minute Walk Test (6MWT) | Reporting change from baseline in distance walked during 6MWT | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 6 months |
|
|
| Primary | Change From Baseline in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) | KCCQ quantifies physical function, symptoms, social function, self-efficiency, knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 30 days and 6 months |
|
|
| Primary | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Reporting of change in left ventricular ejection fraction (LVEF) from baseline by echocardiography | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 6 months |
|
|
| Primary | Change From Baseline in Global Longitudinal Strain (GLS) | Reporting of change in GLS from baseline by echocardiography | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 6 months |
|
|
| Primary | Change From Baseline in Left Ventricular Filling Pressure (E:e') | Reporting of change in left ventricular filling pressure (E:e') from baseline by echocardiography | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 6 months |
|
|
| Primary | Change From Baseline in Stroke Volume Index (SVI) | Reporting of change in stroke volume index (SVI) from baseline by echocardiography | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 6 months |
|
|
| Primary | Change From Baseline in NT-pro B-type Natriuretic Peptide (NT-proBNP) | Reporting of change in NT-pro B-type natriuretic peptide (NT-proBNP) from baseline | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 6 months |
|
|
| Other Pre-specified | All-cause and Cardiovascular Mortality | Rate of all-cause and cardiovascular mortality | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | Annually through 5 years |
|
|
| Other Pre-specified | All Stroke (Disabling and Non-disabling) | Rate of disabling and non-disabling strokes | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | Annually through 5 years |
|
|
| Other Pre-specified | Cardiovascular and Heart Failure Hospitalizations | Rate of cardiovascular and heart failure hospitalizations | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | Annually through 5 years |
|
|
| Other Pre-specified | Heart Failure Events | Rate of heart failure events | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | Annually through 5 years |
|
|
| Other Pre-specified | New York Heart Association (NYHA) Functional Classification | Reporting NYHA functional classification by timepoint following attempted procedure | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | 30 days, 6 months, and annually through 5 years |
|
|
| Other Pre-specified | Change From Baseline in New York Heart Association (NYHA) Functional Classification | Reporting of NYHA classification change from baseline to 30 days and 6 months NYHA Classification criteria: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | Annually through 5 years |
|
|
| Other Pre-specified | Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) | KCCQ quantifies physical function, symptoms, social function, self-efficiency, knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. | No subjects with an attempted TAVR procedure. No data is reported as statistical analysis plan specifies that results would be reported for:
| Posted | Annually through 5 years |
|
|
| Other Pre-specified | Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient | Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure. | Posted | Annually through 5 years |
|
|
| Other Pre-specified | Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by effective orifice area (EOA) | Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure. | Posted | Annually through 5 years |
|
|
| Other Pre-specified | Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular prosthetic regurgitation by Doppler echocardiography | Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure. | Posted | Annually through 5 years |
|
|
| Other Pre-specified | Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography | Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography | Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure. | Posted | Annually through 5 years |
|
|
| Other Pre-specified | Prosthetic Valve Thrombosis | Rate of prosthetic valve thrombosis | Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure. | Posted | 30 days, 6 months, and annually through 5 years |
|
|
| Other Pre-specified | Prosthetic Valve Endocarditis | Rate of prosthetic valve endocarditis | Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure. | Posted | 30 days, 6 months, and annually through 5 years |
|
|
| Other Pre-specified | Bioprosthetic Valve Dysfunction (BVD) | Rate of bioprosthetic valve dysfunction (BVD) | Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure. | Posted | 30 days, 6 months, and annually through 5 years |
|
|
| Other Pre-specified | Bioprosthetic Valve Failure (BVF) | Rate of bioprosthetic valve failure (BVF) | Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure. | Posted | 30 days, 6 months, and annually through 5 years |
|
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| Other Pre-specified | Valve-related Dysfunction Requiring Repeat Procedure | Rate of valve-related dysfunction requiring repeat procedure | Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure. | Posted | Annually through 5 years |
|
|
| 0 |
| 11 |
| 2 |
| 11 |
| 4 |
| 11 |
| Left radial artery pseudoaneurysm following study specific angiogram | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Haematome, left radial | Vascular disorders | Systematic Assessment |
|
| Parasthesia, left thumb and index finger | Nervous system disorders | Systematic Assessment |
|
| Bilateral ovarian cysts | Reproductive system and breast disorders | Systematic Assessment |
|
| Saccular infrarenal abdominal aortic aneurysm | Vascular disorders | Systematic Assessment |
|
Within 60 days of receipt Medtronic (MDT) will verify presence of Confidential Information (CI) & won't censor or interfere with presentation/conclusions except to protect CI (other than Study Data) & its rights in patentable or copyrightable materials, & check technical accuracy of MDT data. If told by MDT that Publication contains CI or technical errors of MDT data, PI will make requested changes before publishing/presenting. PI will delay publication up to 90 more days, if requested.
| D014694 |
| Ventricular Outflow Obstruction |