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A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCutâ„¢ device for splitting bioprosthetic aortic valve leaflets in patients who are presented for a valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) procedure for an approved ViV indication, and who are at risk for TAVR-induced coronary artery ostium obstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ShortCutâ„¢ | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ShortCutâ„¢ | Device | Splitting bioprosthetic aortic valve leaflets |
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| Measure | Description | Time Frame |
|---|---|---|
| (Number of Patients With) ShortCutâ„¢ Device- and/or ShortCutâ„¢ Procedure-related Mortality and All Cause Stroke | Discharge or at 7 days post-procedure, whichever occurs first | |
| (Number of Patients With) Leaflet Splitting Success Using the ShortCutâ„¢ Device | Assessed by echo and/or angiography | Intra-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| (Number of Patients With) All-cause Mortality | (VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. |
| Measure | Description | Time Frame |
|---|---|---|
| (Number of Patients With) All-cause Mortality | (VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson Medical Center | Tucson | Arizona | 85712 | United States | ||
| Smidt Heart Institute Cedars-Sinai Medical |
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66 subjects were found eligible per protocol. 60 subjects were treated with the device (started), after 6 subjects dropped out prior to treatment.
Subjects were enrolled at 22 clinical sites from January 2022 to September 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | ShortCutâ„¢ | ShortCutâ„¢: Splitting bioprosthetic aortic valve leaflets |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Apr 17, 2023 |
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| 30 days post procedure |
| (Number of Patients With) All-cause Stroke | (VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. | 30 days post procedure |
| (Number of Patients With) Coronary Obstruction | (VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. | 30 days post procedure |
| (Number of Patients With) Myocardial Infarction With New Evidence of Coronary Artery Obstruction Requiring Intervention | (VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. | 30 days post procedure |
| (Number of Patients With) Major Vascular Complications | (VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. | 30 days post procedure |
| (Number of Patients With) Cardiac Tamponade | (VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. | 30 days post procedure |
| (Number of Patients With) Acute Kidney Injury | (Acute kidney injury stage 3-4 per VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.
No differentiation was made between the stages when assessing the outcome. | 30 days post procedure |
| (Number of Patients With) Access-related Type 3-4 Bleeding | (VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.
| 30 days post procedure |
| (Number of Patients With) Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet | 30 days post index procedure |
| (Number of Patients With) Freedom From Coronary Artery Intervention Related to the Intervened Leaflet | 30 days post index procedure |
| (Number of Patients With) ShortCutâ„¢ Technical Success | Technical success is defined as a composite of the following:
| At exit from procedure room |
| 90 days post procedure |
| (Number of Patients With) Stroke | (VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. | 90 days post procedure |
| (Number of Patients With) Myocardial Infarction With New Evidence of Coronary Artery Obstruction Requiring Intervention | (VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. | 90 days post procedure |
| Los Angeles |
| California |
| 90048 |
| United States |
| Kaiser Permanente - San Francisco Medical Center | San Francisco | California | 94115 | United States |
| Los Robles Regional Medical Center | Thousand Oaks | California | 91360 | United States |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Carolinas Medical Center / Atrium Health | Charlotte | North Carolina | 28204 | United States |
| UPMC Pinnacle | Wormleysburg | Pennsylvania | 17043 | United States |
| Baylor Scott & White, The Heart Hospital Plano | Plano | Texas | 75093 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| CHU de Bordeaux (Bordeaux University Hospital) | Bordeaux | France |
| Institute Mutualiste Montsouris | Paris | France |
| Clinique Pasteur | Toulouse | France |
| German Heart Institute Berlin | Berlin | Germany |
| University Hospital Hamburg | Hamburg | Germany |
| Leipzig Heart Institute | Leipzig | Germany |
| Sha'are Tzedek Medical Center | Jerusalem | Israel |
| Rabin Medical Center | Petah Tikva | Israel |
| Royal Sussex County Hospital | Brighton | United Kingdom |
| Leeds General Infirmary | Leeds | United Kingdom |
| 30 Days Follow up |
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| 90 Days Follow up |
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| COMPLETED |
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| NOT COMPLETED |
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Includes all patients that were treated with the ShortCut device
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| ID | Title | Description |
|---|---|---|
| BG000 | ShortCutâ„¢ | ShortCutâ„¢: Splitting bioprosthetic aortic valve leaflets |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Surgical risk | Count of Participants | Participants |
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| Coronary artery disease | Count of Participants | Participants |
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| Renal impairment | Count of Participants | Participants |
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| Prior coronary artery bypass grafting | Count of Participants | Participants |
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| Prior stroke | Count of Participants | Participants |
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| Failed Valve Type | Count of Participants | Participants |
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| Aortic valve disease | Count of Participants | Participants |
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| 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 | (Number of Patients With) ShortCutâ„¢ Device- and/or ShortCutâ„¢ Procedure-related Mortality and All Cause Stroke | Posted | Count of Participants | Participants | Discharge or at 7 days post-procedure, whichever occurs first |
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| Primary | (Number of Patients With) Leaflet Splitting Success Using the ShortCutâ„¢ Device | Assessed by echo and/or angiography | Posted | Count of Participants | Participants | Intra-procedure |
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| Secondary | (Number of Patients With) All-cause Mortality | (VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. | Posted | Count of Participants | Participants | 30 days post procedure |
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| Secondary | (Number of Patients With) All-cause Stroke | (VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. | Posted | Count of Participants | Participants | 30 days post procedure |
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| Secondary | (Number of Patients With) Coronary Obstruction | (VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. | Posted | Count of Participants | Participants | 30 days post procedure |
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| Secondary | (Number of Patients With) Myocardial Infarction With New Evidence of Coronary Artery Obstruction Requiring Intervention | (VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. | Posted | Count of Participants | Participants | 30 days post procedure |
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| Secondary | (Number of Patients With) Major Vascular Complications | (VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. | Posted | Count of Participants | Participants | 30 days post procedure |
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| Secondary | (Number of Patients With) Cardiac Tamponade | (VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. | Posted | Count of Participants | Participants | 30 days post procedure |
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| Secondary | (Number of Patients With) Acute Kidney Injury | (Acute kidney injury stage 3-4 per VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.
No differentiation was made between the stages when assessing the outcome. | Posted | Count of Participants | Participants | 30 days post procedure |
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| Secondary | (Number of Patients With) Access-related Type 3-4 Bleeding | (VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.
| Posted | Count of Participants | Participants | 30 days post procedure |
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| Secondary | (Number of Patients With) Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet | Posted | Count of Participants | Participants | 30 days post index procedure |
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| Secondary | (Number of Patients With) Freedom From Coronary Artery Intervention Related to the Intervened Leaflet | Posted | Count of Participants | Participants | 30 days post index procedure |
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| Secondary | (Number of Patients With) ShortCutâ„¢ Technical Success | Technical success is defined as a composite of the following:
| Posted | Count of Participants | Participants | At exit from procedure room |
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| Other Pre-specified | (Number of Patients With) All-cause Mortality | (VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. | Posted | Count of Participants | Participants | 90 days post procedure |
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| Other Pre-specified | (Number of Patients With) Stroke | (VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. | Posted | Count of Participants | Participants | 90 days post procedure |
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| Other Pre-specified | (Number of Patients With) Myocardial Infarction With New Evidence of Coronary Artery Obstruction Requiring Intervention | (VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. | Posted | Count of Participants | Participants | 90 days post procedure |
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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 | ShortCutâ„¢ | ShortCutâ„¢: Splitting bioprosthetic aortic valve leaflets | 3 | 60 | 13 | 60 | 5 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All-cause stroke | Nervous system disorders | Non-systematic Assessment | Per VARC-3 |
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| Coronary obstruction | Cardiac disorders | Non-systematic Assessment | Per VARC-3 |
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| Myocardial Infarction with new evidence of coronary artery obstruction requiring intervention | Cardiac disorders | Non-systematic Assessment | Per VARC-3 |
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| Cardiac tamponade | Cardiac disorders | Non-systematic Assessment | Per VARC-3 |
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| Acute kidney injury stage 3-4 | Renal and urinary disorders | Non-systematic Assessment | Per VARC-3 |
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| Permanent pacemaker | Cardiac disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left Bundle Branch Block (LBBB) | 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 |
| May 23, 2024 |
| Prot_SAP_000.pdf |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| None/mild |
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| Mixed failure (both Aortic Stenosis and Aortic Regurgitation) |
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