Aortic Stenosis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICESelf-Centering Guide Catheter
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
* Subject must be at least 18 years of age. * Subject (or legal guardian) understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed. * Subject is eligible for and is an acceptable candidate for transcatheter aortic valve replacement of a stenotic (aortic valve area ≤1 cm2, aortic jet velocity ≥4.0 m/s, or mean gradient ≥40 mmHg) native valve with a transcatheter aortic valve that is introduced percutaneously via the femoral artery using conventional catheterization techniques.
Exclusion criteria
* Subject has known hypersensitivity to the components of the device (e.g., polyether block amide, fluoropolymers, nickel, platinum, tantalum, titanium). * Subject has a pre-existing prosthetic aortic valve.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Through study completion, up to 72 hours post-procedure | This outcome will be assessed via physician determination and will be recorded in the case report form. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time From Insertion of the Self-Centering Guide Catheter Into the Body to Removal of the Self-Centering Guide Catheter From the Body | 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 | Through study completion, up to 72 hours post-procedure | 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. |
| Number of Self-Centering Guide Catheters With Device Success | Through study completion, up to 72 hours post-procedure | 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. |
| Number of Participants With Stroke | 72 hours post-procedure | — |
| 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 | — |
| 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 | 72 hours post-procedure | 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 |
| Number of Participants With Cardiac Tamponade | 72 hours post-procedure | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Self-Centering Guide Catheter |
|---|---|
| Age, Continuous | 78.0 years STANDARD_DEVIATION 9.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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.
Time frame: Through study completion, up to 72 hours post-procedure
Population: 20 patients were treated with 23 devies
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Self-Centering Guide Catheter | 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 | 18 Device |
Other Pre-specified
Any Adverse Event Occurring While the Self-Centering Guide Catheter is in the Subject
Time frame: 72 hours post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Centering Guide Catheter | Any Adverse Event Occurring While the Self-Centering Guide Catheter is in the Subject | 0 Participants |
Other Pre-specified
Any Device-related Adverse Event
Time frame: 72 hours post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Centering Guide Catheter | Any Device-related Adverse Event | 0 Participants |
Other Pre-specified
Death, All-cause, Cardiovascular, and Non-cardiovascular
Time frame: 72 hours post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Centering Guide Catheter | Death, All-cause, Cardiovascular, and Non-cardiovascular | 0 Participants |
Other Pre-specified
Number of Attempts Made to Cross the Stenotic Native Aortic Valve With a PTFE-coated Guidewire
Time frame: Through study completion, up to 72 hours post-procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Self-Centering Guide Catheter | Number of Attempts Made to Cross the Stenotic Native Aortic Valve With a PTFE-coated Guidewire | 5.1 Attempts |
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
Time frame: 72 hours post-procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Self-Centering Guide Catheter | Number of Device Deficiencies Including But Not Limited to Failures, Malfunctions, Use Errors, Product Nonconformities, and Labeling Errors | 1 Device |
Other Pre-specified
Number of Participants With Cardiac Tamponade
Time frame: 72 hours post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Centering Guide Catheter | Number of Participants With Cardiac Tamponade | 0 Participants |
Other Pre-specified
Number of Participants With Stroke
Time frame: 72 hours post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Centering Guide Catheter | Number of Participants With Stroke | 0 Participants |
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.
Time frame: Through study completion, up to 72 hours post-procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Self-Centering Guide Catheter | Number of Self-Centering Guide Catheters With Device Success | 18 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.
Time frame: Through study completion, up to 72 hours post-procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Self-Centering Guide Catheter | 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 | 23 Device |
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
Time frame: Through study completion, up to 72 hours post-procedure
Population: A guide wire was delivered through the self-centering guide catheter in 18/20 patients. In total 23 devices were used.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Self-Centering Guide Catheter | Time From Insertion of the Self-Centering Guide Catheter Into the Body to Removal of the Self-Centering Guide Catheter From the Body | 6.6 minutes |
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
Time frame: Through study completion, up to 72 hours post-procedure
Population: A guide wire was delivered through the self-centering guide catheter in 18/20 patients.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Self-Centering Guide Catheter | 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 | 3.8 minutes |