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| Name | Class |
|---|---|
| Pacific Clinical Research Group | OTHER |
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The objective of the study is to observe the safety, efficacy and cost effectiveness of the Edwards SAPIEN XT valve for the treatment of severe calcific degenerative aortic stenosis.
This is a multi-centre, prospective, consecutively enrolled, non-randomized clinical trial. The comparatator group will consist of subjects undergoing surgical aortic valve replacement in Cohort A of the PARTNER II Trial [NCT01314313].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | SAPIEN XTâ„¢ valve with the NovaFlex and NovaFlex+ delivery systems. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAVR Implantation of the Transcatheter Aortic Valve Prosthesis | Device | Operable subjects |
|
| Measure | Description | Time Frame |
|---|---|---|
| VARC-2 Composite Safety Endpoint | The primary endpoint is a VARC-2 Composite. It comprises of
A composite endpoint is an endpoint that is a combination of multiple components. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| All Cause Mortality | 30 days | |
| All Cause Mortality | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Owen Christopher Raffel | The Prince Charles Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia | ||
| Macquarie Unversity Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | TAVR With SAPIEN XT THV | SAPIEN XTâ„¢ THV with the NovaFlex and NovaFlex+ delivery systems. TAVR Implantation of the Transcatheter Aortic Valve Prosthesis: Operable subjects |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TAVR With SAPIEN XT THV | SAPIEN XTâ„¢ THV with the NovaFlex and NovaFlex+ delivery systems. TAVR Implantation of the Transcatheter Aortic Valve Prosthesis: Operable subjects |
| 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 | VARC-2 Composite Safety Endpoint | The primary endpoint is a VARC-2 Composite. It comprises of
A composite endpoint is an endpoint that is a combination of multiple components. | Posted | Number | percentage of patients | 30 days |
|
All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented.
All Adverse Events are site-reported.
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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 With SAPIEN XT THV | SAPIEN XTâ„¢ THV with the NovaFlex and NovaFlex+ delivery systems. TAVR Implantation of the Transcatheter Aortic Valve Prosthesis: Operable subjects |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal lab value | Investigations | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Access site and access related vascular injury - Hematoma | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tenley Koepnick | Edwards Lifesciences | tenley.koepnick@edwards.com |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Macquarie Park |
| New South Wales |
| 2109 |
| Australia |
| Prince of Wales Hospital | Randwick | New South Wales | 2031 | Australia |
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
| The Prince Charles Hospital | Chermside | Queensland | 4032 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| St Vincent's Hospital - MELBOURNE | Melbourne | Victoria | 3065 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Royal Perth Hospital/Fiona Stanley Hospital | Perth | Western Australia | 6000 | Australia |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| STS Score | The Society of Thoracic Surgeons (STS) score measures patient risk at the time of cardiovascular surgery on a scale that ranges from 0% to 100%, with higher numbers indicating greater risk. | Mean | Standard Deviation | units on a scale |
|
| NYHA I/II | New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort. | Count of Participants | Participants |
|
| NYHA III/IV | New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort. | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | All Cause Mortality | Posted | Number | percentage of patients | 30 days |
|
|
|
| Secondary | All Cause Mortality | Posted | Number | percentage of participants | 12 months |
|
|
|
| 17 |
| 199 |
| 73 |
| 199 |
| 182 |
| 199 |
| Access site and access related vascular injury - Dissection | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Access site and access related vascular injury - Distal embolization (noncerebral) | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment | Access site and access related vascular injury - Distal embolization (noncerebral) from vascular source |
|
| Access site and access related vascular injury - Failure of percutaneous access site closure | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment | Access site and access related vascular injury - Failure of percutaneous access site closure resulting in intervention |
|
| Access site and access related vascular injury - Hematoma | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Access site and access related vascular injury - Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Access site and access related vascular injury - Rupture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Access site and access related vascular injury - Ventricular rupture (Apical rupture) | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Anemia/Hemolytic anemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Angina/Cardiac chest pain | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arrhythmia/Conduction system injury (defect) | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bleeding - Hemorrhage | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac tamponade/Pericardial effusion | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Device migration/malposition requiring intervention | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Embolization including air/calcific valve material or Thrombus | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Gastro Intestinal event - Non-hemorrhagic | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Heart failure/CHF/Low output failure | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Infection - Respiratory infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Infection - Urinary tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mental state change (not neurological) - Confusion | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Miscellaneous - Other | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Multi organ failure | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Neurological - Hemorrhagic stroke | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neurological - Ischemic stroke | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neurological - Other | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neurological - Other new neurological sign consistent with stroke | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neurological - TIA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Renal insufficiency or renal failure | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Respiratory event - Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Respiratory event - Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Respiratory event - Other | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Respiratory event - Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Respiratory event - Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Syncope | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Unknown cause of death | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Other | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Genito-Urinary event - Non-hemorrhagic | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Anemia/Hemolytic anemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arrhythmia/Conduction system injury (defect) | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bleeding - Hemorrhage | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal - Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Other | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Abnormal Labs | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Genito-Urinary event - Non-hemorrhagic | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertension | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Infection - Respiratory infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Mental state change (not neurological) - Confusion | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Renal insufficiency or renal failure | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Miscellaneous - Other | General disorders | MedDRA 10.0 | Systematic Assessment |
|
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| D014694 |
| Ventricular Outflow Obstruction |