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A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCutâ„¢ device (The ShortCutâ„¢ CAS).
The continued access study will be used to collect additional safety and effectiveness data of the ShortCutâ„¢ device for splitting bioprosthetic aortic valve leaflets, and to demonstrate coronary artery ostia patency following leaflet split, in patients who are at risk for TAVR-induced coronary artery ostium obstruction following a ViV procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shortcut | Experimental | Splitting bioprosthetic aortic valve leaflets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shortcut | Device | Splitting bioprosthetic aortic valve leaflets |
|
| Measure | Description | Time Frame |
|---|---|---|
| ShortCutâ„¢ Device- and/or ShortCutâ„¢ Procedure-related: Mortality, Stroke | Primary safety endpoint, ShortCutâ„¢ device- and/or ShortCutâ„¢ procedure-related: Mortality, Stroke | discharge or at 7 days post-procedure, whichever occurs first |
| Number of Participants With Leaflet Splitting Success Using the Shortcut Device, Assessed by Echo and/or Angiography | Primary effectiveness endpoint, Leaflet splitting success using the Shortcut Device, assessed by echo and/or angiography | Intra-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of All Cause Mortality, Per VARC 3 | Secondary safety endpoint, Rate of all cause mortality, per VARC 3 | 30 days post procedure |
| Rate of All-cause Stroke, Per VARC-3 | Secondary safety endpoint, Rate of all-cause stroke, per VARC-3 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of All Cause Mortality Per VARC-3 | Tertiary Safety Endpoint, Rate of all cause mortality per VARC-3 | 90 days post procedure |
| Rate of Stroke Per VARC-3 | Tertiary Safety Endpoint, Rate of stroke per VARC-3 |
Inclusion Criteria:
Exclusion Criteria:
8. Need for emergency surgery for any reason. 9. Life expectancy is less than 1 year.
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| Name | Affiliation | Role |
|---|---|---|
| Hadas Givon | Pi-cardia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Robles Regional Medical Center | Thousand Oaks | California | 91360 | United States | ||
| Morristown Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Shortcut | Shortcut: Splitting bioprosthetic aortic valve leaflets |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Shortcut | Shortcut: Splitting bioprosthetic aortic valve leaflets |
| 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 | ShortCutâ„¢ Device- and/or ShortCutâ„¢ Procedure-related: Mortality, Stroke | Primary safety endpoint, ShortCutâ„¢ device- and/or ShortCutâ„¢ procedure-related: Mortality, Stroke | Posted | Number | Participants | discharge or at 7 days post-procedure, whichever occurs first |
|
|
Adverse Events (AEs) reported from point of index procedure until 90 days post procedure
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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 | Shortcut | Shortcut: Splitting bioprosthetic aortic valve leaflets | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hadas Givon, VP CA/RA | Pi-Cardia | +972-8-9484800 | hadas@pi-cardia.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 8, 2024 | Nov 3, 2025 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 30 days post procedure |
| Rate of Coronary Obstruction Per VARC-3 | Secondary safety endpoint, Rate of coronary obstruction per VARC-3 | 30 days post procedure |
| Rate of MI With New Evidence of Coronary Artery Obstruction Requiring Intervention Per VARC-3 | Secondary safety endpoint, Rate of MI with new evidence of coronary artery obstruction requiring intervention per VARC-3 | 30 days post procedure |
| -Rate of Major Vascular Complications Per VARC-3 | Secondary safety endpoint, -Rate of major vascular complications per VARC-3 | 30 days post procedure |
| Rate of Cardiac Temponade Per VARC-3 | Secondary safety endpoint, Rate of cardiac temponade per VARC-3 | 30 days post procedure |
| Rate of Acute Kidney Injury Per VARC-3 | Secondary safety endpoint, Rate of Acute Kidney Injury per VARC-3 | 30 days post procedure |
| Access-related Type 3-4 Bleeding Per VARC-3 | Secondary safety endpoint, Access-related type 3-4 bleeding per VARC-3 | 30 days post procedure |
| Rate of Freedom From Coronary Artery Intervention Related to the Intervened Leaflet | Secondary effectiveness endpoint, Rate of freedom from coronary artery intervention related to the intervened leaflet | 30 days post procedure |
| Rate of Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet | Secondary effectiveness endpoint, Rate of freedom from coronary artery ostia obstruction related to the intervened leaflet | 30 days post procedure |
| Shortcut Technical Success | Technical success endpoint, Shortcut technical success - Successful access, delivery, and retrieval of the ShortCutâ„¢ device. | At exit from procedure room, immediately after the procedure |
| 90 days post procedure |
| Rate of MI With New Evidence of Coronary Artery Obstruction Requiring Intervention Per VARC-3 | Tertiary Safety Endpoint, Rate of MI with new evidence of coronary artery obstruction requiring intervention per VARC-3 | 90 days post procedure |
| Morristown |
| New Jersey |
| 07960 |
| United States |
| Columbia University Medical Center /NYPH | New York | New York | 10032 | United States |
| UPMC Pinnacle | Wormleysburg | Pennsylvania | 17043 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| STS score | STS: Society of Thoracic Surgeons (STS) Risk Score - estimates the risk of mortality and major morbidity following cardiac surgery. Range: 0% to 100% (represents the predicted probability of death or a major adverse event) Typical Range Observed in Clinical Use: Usually <1% to ~20%, depending on procedure and patient risk profile. Directionality: Higher values = worse outcomes / higher surgical risk Lower values = better outcomes / lower surgical risk | Mean | Standard Deviation | units on a scale |
|
|
| Primary | Number of Participants With Leaflet Splitting Success Using the Shortcut Device, Assessed by Echo and/or Angiography | Primary effectiveness endpoint, Leaflet splitting success using the Shortcut Device, assessed by echo and/or angiography | Posted | Count of Participants | Participants | Intra-procedure |
|
|
|
| Secondary | Rate of All Cause Mortality, Per VARC 3 | Secondary safety endpoint, Rate of all cause mortality, per VARC 3 | Posted | Count of Participants | Participants | 30 days post procedure |
|
|
|
| Secondary | Rate of All-cause Stroke, Per VARC-3 | Secondary safety endpoint, Rate of all-cause stroke, per VARC-3 | Posted | Count of Participants | Participants | 30 days post procedure |
|
|
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| Secondary | Rate of Coronary Obstruction Per VARC-3 | Secondary safety endpoint, Rate of coronary obstruction per VARC-3 | Posted | Count of Participants | Participants | 30 days post procedure |
|
|
|
| Secondary | Rate of MI With New Evidence of Coronary Artery Obstruction Requiring Intervention Per VARC-3 | Secondary safety endpoint, Rate of MI with new evidence of coronary artery obstruction requiring intervention per VARC-3 | Posted | Count of Participants | Participants | 30 days post procedure |
|
|
|
| Secondary | -Rate of Major Vascular Complications Per VARC-3 | Secondary safety endpoint, -Rate of major vascular complications per VARC-3 | Posted | Count of Participants | Participants | 30 days post procedure |
|
|
|
| Secondary | Rate of Cardiac Temponade Per VARC-3 | Secondary safety endpoint, Rate of cardiac temponade per VARC-3 | Posted | Count of Participants | Participants | 30 days post procedure |
|
|
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| Secondary | Rate of Acute Kidney Injury Per VARC-3 | Secondary safety endpoint, Rate of Acute Kidney Injury per VARC-3 | Posted | Count of Participants | Participants | 30 days post procedure |
|
|
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| Secondary | Access-related Type 3-4 Bleeding Per VARC-3 | Secondary safety endpoint, Access-related type 3-4 bleeding per VARC-3 | Posted | Count of Participants | Participants | 30 days post procedure |
|
|
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| Secondary | Rate of Freedom From Coronary Artery Intervention Related to the Intervened Leaflet | Secondary effectiveness endpoint, Rate of freedom from coronary artery intervention related to the intervened leaflet | Posted | Count of Participants | Participants | 30 days post procedure |
|
|
|
| Secondary | Rate of Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet | Secondary effectiveness endpoint, Rate of freedom from coronary artery ostia obstruction related to the intervened leaflet | Posted | Count of Participants | Participants | 30 days post procedure |
|
|
|
| Secondary | Shortcut Technical Success | Technical success endpoint, Shortcut technical success - Successful access, delivery, and retrieval of the ShortCutâ„¢ device. | Posted | Count of Participants | Participants | At exit from procedure room, immediately after the procedure |
|
|
|
| Other Pre-specified | Rate of All Cause Mortality Per VARC-3 | Tertiary Safety Endpoint, Rate of all cause mortality per VARC-3 | Posted | Count of Participants | Participants | 90 days post procedure |
|
|
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| Other Pre-specified | Rate of Stroke Per VARC-3 | Tertiary Safety Endpoint, Rate of stroke per VARC-3 | Posted | Count of Participants | Participants | 90 days post procedure |
|
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| Other Pre-specified | Rate of MI With New Evidence of Coronary Artery Obstruction Requiring Intervention Per VARC-3 | Tertiary Safety Endpoint, Rate of MI with new evidence of coronary artery obstruction requiring intervention per VARC-3 | Posted | Count of Participants | Participants | 90 days post procedure |
|
|
|
| 8 |
| 2 |
| 8 |
| 0 |
| 8 |
| Cardiac standstill | Cardiac disorders | Non-systematic Assessment |
|
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| D014694 |
| Ventricular Outflow Obstruction |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |