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An evaluation of the feasibility of using the Self-Centering Guide Catheter to deliver a guide wire across a stenotic native aortic valve into the left ventricle.
A prospective, open-label, single-arm feasibility study evaluating the Self-Centering Guide Catheter. All subjects who are candidates for transcatheter aortic valve replacement (TAVR) of a native valve with a transcatheter aortic valve that is introduced percutaneously via the femoral artery using conventional catheterization techniques will be evaluated for enrollment in this study. The Self-Centering Guide Catheter is intended to facilitate delivery of a guidewire across a stenotic native aortic valve and into the left ventricle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-Centering Guide Catheter | Experimental | Subjects who provided written informed consent and an attempt is made to insert the Self-Centering Guide Catheter into the subject's femoral artery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-Centering Guide Catheter | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Self-Centering Guide Catheters Successfully Used to Deliver a Guide Wire Through the Self-Centering Guide Catheter Across the Stenotic Native Aortic Valve Into the Left Ventricle | This outcome will be assessed via physician determination and will be recorded in the case report form. | Through study completion, up to 72 hours post-procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Time From Insertion of the Self-Centering Guide Catheter Into the Body to Successful Placement of a PTFE-coated Guidewire Across the Stenotic Native Aortic Valve | Through study completion, up to 72 hours post-procedure | |
| Time From Insertion of the Self-Centering Guide Catheter Into the Body to Removal of the Self-Centering Guide Catheter From the Body |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajiv Gulati, MD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Self-Centering Guide Catheter | Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Self-Centering Guide Catheter | Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery. |
| 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 |
| 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 Self-Centering Guide Catheters Successfully Used to Deliver a Guide Wire Through the Self-Centering Guide Catheter Across the Stenotic Native Aortic Valve Into the Left Ventricle | This outcome will be assessed via physician determination and will be recorded in the case report form. | 20 patients were treated with 23 devies | Posted | Count of Units | Device | Through study completion, up to 72 hours post-procedure | Device | Device |
|
|
Adverse event data was collected through 72 hours or discharge, whichever came first. There were no Adverse Events, Serious Adverse Events or Unanticipated Adverse Device Events, reported during the study period.
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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 | Self-Centering Guide Catheter | Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rajiv Gulati | Mayo Clinic | 507-538-6325 | Gulati.Rajiv@mayo.edu |
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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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| Through study completion, up to 72 hours post-procedure |
| Number of Attempts Made to Cross the Stenotic Native Aortic Valve With a PTFE-coated Guidewire | Through study completion, up to 72 hours post-procedure |
| Successful Recapture of the Distal Self-centering Basket of the Device Into the Guide and Withdrawal of the Self-Centering Guide Catheter Through the Guide System | The outcome measure of successful recapture of the distal self-centering basket of the device into the guide and withdrawal of the Self-Centering Guide Catheter through the guide system will be assessed via physician assessment of the self-centering basket recapture and will be recorded in the case report form. | Through study completion, up to 72 hours post-procedure |
| Number of Self-Centering Guide Catheters With Device Success | Device success is defined as successful delivery of a guide wire through the Self-Centering Guide Catheter across the stenotic native aortic valve into the left ventricle and successful recapture of the distal self-centering basket of the device into the guide and withdrawal of the Self-Centering Guide Catheter through the guide system. This outcome will be assessed via physician determination and will be recorded in the case report form. | Through study completion, up to 72 hours post-procedure |
| Number of Participants With Stroke | 72 hours post-procedure |
| Number of Participants With Cardiac Tamponade | 72 hours post-procedure |
| Death, All-cause, Cardiovascular, and Non-cardiovascular | 72 hours post-procedure |
| Any Device-related Adverse Event | 72 hours post-procedure |
| Any Adverse Event Occurring While the Self-Centering Guide Catheter is in the Subject | 72 hours post-procedure |
| Number of Device Deficiencies Including But Not Limited to Failures, Malfunctions, Use Errors, Product Nonconformities, and Labeling Errors | All device deficiencies including but not limited to failures, malfunctions, use errors, product nonconformities, and labeling errors will be recorded in the case report form | 72 hours post-procedure |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Counts |
|---|
| Participants |
|
| Device |
|
|
| Other Pre-specified | Time From Insertion of the Self-Centering Guide Catheter Into the Body to Successful Placement of a PTFE-coated Guidewire Across the Stenotic Native Aortic Valve | A guide wire was delivered through the self-centering guide catheter in 18/20 patients. | Posted | Mean | 95% Confidence Interval | minutes | Through study completion, up to 72 hours post-procedure |
|
|
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| Other Pre-specified | Time From Insertion of the Self-Centering Guide Catheter Into the Body to Removal of the Self-Centering Guide Catheter From the Body | A guide wire was delivered through the self-centering guide catheter in 18/20 patients. In total 23 devices were used. | Posted | Mean | 95% Confidence Interval | minutes | Through study completion, up to 72 hours post-procedure | Devices | Devices |
|
|
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| Other Pre-specified | Number of Attempts Made to Cross the Stenotic Native Aortic Valve With a PTFE-coated Guidewire | Posted | Mean | 95% Confidence Interval | Attempts | Through study completion, up to 72 hours post-procedure | Device | Device |
|
|
|
| Other Pre-specified | Successful Recapture of the Distal Self-centering Basket of the Device Into the Guide and Withdrawal of the Self-Centering Guide Catheter Through the Guide System | The outcome measure of successful recapture of the distal self-centering basket of the device into the guide and withdrawal of the Self-Centering Guide Catheter through the guide system will be assessed via physician assessment of the self-centering basket recapture and will be recorded in the case report form. | Posted | Count of Units | Device | Through study completion, up to 72 hours post-procedure | Device | Device |
|
|
|
| Other Pre-specified | Number of Self-Centering Guide Catheters With Device Success | Device success is defined as successful delivery of a guide wire through the Self-Centering Guide Catheter across the stenotic native aortic valve into the left ventricle and successful recapture of the distal self-centering basket of the device into the guide and withdrawal of the Self-Centering Guide Catheter through the guide system. This outcome will be assessed via physician determination and will be recorded in the case report form. | Posted | Count of Units | Device | Through study completion, up to 72 hours post-procedure | Device | Device |
|
|
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| Other Pre-specified | Number of Participants With Stroke | Posted | Count of Participants | Participants | 72 hours post-procedure |
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|
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| Other Pre-specified | Number of Participants With Cardiac Tamponade | Posted | Count of Participants | Participants | 72 hours post-procedure |
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|
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| Other Pre-specified | Death, All-cause, Cardiovascular, and Non-cardiovascular | Posted | Count of Participants | Participants | 72 hours post-procedure |
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| Other Pre-specified | Any Device-related Adverse Event | Posted | Count of Participants | Participants | 72 hours post-procedure |
|
|
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| Other Pre-specified | Any Adverse Event Occurring While the Self-Centering Guide Catheter is in the Subject | Posted | Count of Participants | Participants | 72 hours post-procedure |
|
|
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| Other Pre-specified | Number of Device Deficiencies Including But Not Limited to Failures, Malfunctions, Use Errors, Product Nonconformities, and Labeling Errors | All device deficiencies including but not limited to failures, malfunctions, use errors, product nonconformities, and labeling errors will be recorded in the case report form | Posted | Count of Units | Device | 72 hours post-procedure | Device | Device |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| D014694 |
| Ventricular Outflow Obstruction |