Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure
Conditions
Brief summary
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ 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.
Interventions
DEVICEShortCut™
Splitting bioprosthetic aortic valve leaflets
Sponsors
Pi-cardia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved valve-in-valve indication due to a failed bioprosthetic valve. * Written informed consent to participate in the study obtained from the subject or subject's legal representative, according to local regulations, prior to initiation of any study mandated procedure.
Exclusion criteria
* An excessive aortic valve leaflet Calcium morphology or anatomy not suitable for the use of the ShortCut™ device. * Coronary, carotid or vertebral artery disease that, in the opinion of the local Heart Team, should be treated; or treatment of such disease ≤ 1 month prior to index procedure. * Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) ≤ 6 months prior to index procedure, or severe neurological disability. * Myocardial infarction (MI) ≤ 6 weeks prior to index procedure. * Hemodynamic or respiratory instability. * Left ventricle ejection fraction \< 30%. * Ongoing severe infection, sepsis or endocarditis. * Renal insufficiency * Need for emergency surgery for any reason. * Life expectancy is less than 1 year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| (Number of Patients With) ShortCut™ Device- and/or ShortCut™ 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 ShortCut™ Device | Intra-procedure | Assessed by echo and/or angiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| (Number of Patients With) All-cause Stroke | 30 days post procedure | (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. |
| (Number of Patients With) Coronary Obstruction | 30 days post procedure | (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. |
| (Number of Patients With) Myocardial Infarction With New Evidence of Coronary Artery Obstruction Requiring Intervention | 30 days post procedure | (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. |
| (Number of Patients With) Major Vascular Complications | 30 days post procedure | (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. |
| (Number of Patients With) Cardiac Tamponade | 30 days post procedure | (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. |
| (Number of Patients With) All-cause Mortality | 30 days post procedure | (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. |
| (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) ShortCut™ Technical Success | At exit from procedure room | Technical success is defined as a composite of the following: * Successful access, delivery, and retrieval of the ShortCut™ device * Freedom from ShortCut™ device- and/or ShortCut™ procedure-related mortality * Freedom from ShortCut™ device- and/or ShortCut™ procedure-related: Surgery or intervention, Major vascular or access-related complications, Cardiac structural complication. |
| (Number of Patients With) Acute Kidney Injury | 30 days post procedure | (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. * Acute kidney injury stage 3: * Increase in serum creatinine \>300% (\>3.0 X increase) within 7 days compared with baseline * Serum creatinine ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of ≥0.5 mg/dL (≥44 mmol/L) * Acute kidney injury stage 4: * AKI requiring new temporary or permanent renal replacement therapy No differentiation was made between the stages when assessing the outcome. |
| (Number of Patients With) Access-related Type 3-4 Bleeding | 30 days post procedure | (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. * Type 3 bleeding: * Overt bleeding causing hypovolemic shock or severe hypotension (systolic blood pressure \<90 mmHg lasting \>30 min and not responding to volume resuscitation) or requiring vasopressors or surgery (BARC 3b) * Overt bleeding requiring reoperation, surgical exploration, or reintervention for the purpose of controlling bleeding (BARC 3b, BARC 4) * Overt bleeding requiring a transfusion of ≥5 units of whole blood/red blood cells (BARC 3a) * Overt bleeding associated with a hemoglobin drop ≥5 g/dL (≥3.1 mmol/L) (BARC 3b) * Type 4 bleeding: * Overt bleeding leading |
Other
| Measure | Time frame | Description |
|---|---|---|
| (Number of Patients With) All-cause Mortality | 90 days post procedure | (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. |
| (Number of Patients With) Stroke | 90 days post procedure | (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. |
| (Number of Patients With) Myocardial Infarction With New Evidence of Coronary Artery Obstruction Requiring Intervention | 90 days post procedure | (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. |
Countries
France, Germany, Israel, United Kingdom, United States
Participant flow
Recruitment details
Subjects were enrolled at 22 clinical sites from January 2022 to September 2023.
Pre-assignment details
66 subjects were found eligible per protocol. 60 subjects were treated with the device (started), after 6 subjects dropped out prior to treatment.
Participants by arm
| Arm | Count |
|---|---|
| ShortCut™ ShortCut™: Splitting bioprosthetic aortic valve leaflets | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
Baseline characteristics
| Characteristic | ShortCut™ |
|---|---|
| Age, Continuous | 77.0 Years STANDARD_DEVIATION 9.6 |
| Aortic valve disease Aortic Regurgitation (AR) | 7 Participants |
| Aortic valve disease Aortic Stenosis (AS) | 35 Participants |
| Aortic valve disease Mixed failure (both Aortic Stenosis and Aortic Regurgitation) | 18 Participants |
| Coronary artery disease | 26 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Failed Valve Type Surgical Aortic Valve Replacement (SAVR) | 58 Participants |
| Failed Valve Type Transcatheter Aortic Valve Replacement (TAVR) | 2 Participants |
| Prior coronary artery bypass grafting | 13 Participants |
| Prior stroke | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants |
| Race (NIH/OMB) White | 42 Participants |
| Renal impairment Moderate | 24 Participants |
| Renal impairment None/mild | 16 Participants |
| Renal impairment Severe | 20 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 18 Participants |
| Surgical risk Extremely high | 6 Participants |
| Surgical risk HIgh | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 60 |
| other Total, other adverse events | 5 / 60 |
| serious Total, serious adverse events | 13 / 60 |
Outcome results
Primary
(Number of Patients With) Leaflet Splitting Success Using the ShortCut™ Device
Assessed by echo and/or angiography
Time frame: Intra-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ShortCut™ | (Number of Patients With) Leaflet Splitting Success Using the ShortCut™ Device | 60 Participants |
Primary
(Number of Patients With) ShortCut™ Device- and/or ShortCut™ Procedure-related Mortality and All Cause Stroke
Time frame: Discharge or at 7 days post-procedure, whichever occurs first
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ShortCut™ | (Number of Patients With) ShortCut™ Device- and/or ShortCut™ Procedure-related Mortality and All Cause Stroke | All-cause mortality | 0 Participants |
| ShortCut™ | (Number of Patients With) ShortCut™ Device- and/or ShortCut™ Procedure-related Mortality and All Cause Stroke | All-cause stroke | 1 Participants |
| ShortCut™ | (Number of Patients With) ShortCut™ Device- and/or ShortCut™ Procedure-related Mortality and All Cause Stroke | No ShortCut™ device- and/or ShortCut™ procedure-related mortality and all cause stroke | 59 Participants |
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. * Type 3 bleeding: * Overt bleeding causing hypovolemic shock or severe hypotension (systolic blood pressure \<90 mmHg lasting \>30 min and not responding to volume resuscitation) or requiring vasopressors or surgery (BARC 3b) * Overt bleeding requiring reoperation, surgical exploration, or reintervention for the purpose of controlling bleeding (BARC 3b, BARC 4) * Overt bleeding requiring a transfusion of ≥5 units of whole blood/red blood cells (BARC 3a) * Overt bleeding associated with a hemoglobin drop ≥5 g/dL (≥3.1 mmol/L) (BARC 3b) * Type 4 bleeding: * Overt bleeding leading
Time frame: 30 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ShortCut™ | (Number of Patients With) Access-related Type 3-4 Bleeding | 0 Participants |
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. * Acute kidney injury stage 3: * Increase in serum creatinine \>300% (\>3.0 X increase) within 7 days compared with baseline * Serum creatinine ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of ≥0.5 mg/dL (≥44 mmol/L) * Acute kidney injury stage 4: * AKI requiring new temporary or permanent renal replacement therapy No differentiation was made between the stages when assessing the outcome.
Time frame: 30 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ShortCut™ | (Number of Patients With) Acute Kidney Injury | 2 Participants |
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.
Time frame: 30 days post procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ShortCut™ | (Number of Patients With) All-cause Mortality | All-cause mortality | 2 Participants |
| ShortCut™ | (Number of Patients With) All-cause Mortality | Cardiovascular mortality | 0 Participants |
| ShortCut™ | (Number of Patients With) All-cause Mortality | No all-cause mortality | 58 Participants |
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.
Time frame: 30 days post procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ShortCut™ | (Number of Patients With) All-cause Stroke | Fatal stroke | 0 Participants |
| ShortCut™ | (Number of Patients With) All-cause Stroke | Stroke with disability | 1 Participants |
| ShortCut™ | (Number of Patients With) All-cause Stroke | Stroke without disability | 0 Participants |
| ShortCut™ | (Number of Patients With) All-cause Stroke | No all-cause stroke | 59 Participants |
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.
Time frame: 30 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ShortCut™ | (Number of Patients With) Cardiac Tamponade | 1 Participants |
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.
Time frame: 30 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ShortCut™ | (Number of Patients With) Coronary Obstruction | 3 Participants |
Secondary
(Number of Patients With) Freedom From Coronary Artery Intervention Related to the Intervened Leaflet
Time frame: 30 days post index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ShortCut™ | (Number of Patients With) Freedom From Coronary Artery Intervention Related to the Intervened Leaflet | 56 Participants |
Secondary
(Number of Patients With) Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet
Time frame: 30 days post index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ShortCut™ | (Number of Patients With) Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet | 57 Participants |
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.
Time frame: 30 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ShortCut™ | (Number of Patients With) Major Vascular Complications | 0 Participants |
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.
Time frame: 30 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ShortCut™ | (Number of Patients With) Myocardial Infarction With New Evidence of Coronary Artery Obstruction Requiring Intervention | 2 Participants |
Secondary
(Number of Patients With) ShortCut™ Technical Success
Technical success is defined as a composite of the following: * Successful access, delivery, and retrieval of the ShortCut™ device * Freedom from ShortCut™ device- and/or ShortCut™ procedure-related mortality * Freedom from ShortCut™ device- and/or ShortCut™ procedure-related: Surgery or intervention, Major vascular or access-related complications, Cardiac structural complication.
Time frame: At exit from procedure room
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ShortCut™ | (Number of Patients With) ShortCut™ Technical Success | 59 Participants |
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.
Time frame: 90 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ShortCut™ | (Number of Patients With) All-cause Mortality | 3 Participants |
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.
Time frame: 90 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ShortCut™ | (Number of Patients With) Myocardial Infarction With New Evidence of Coronary Artery Obstruction Requiring Intervention | 2 Participants |
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.
Time frame: 90 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ShortCut™ | (Number of Patients With) Stroke | 1 Participants |