Back to resultsSelf-Centering Guide Catheter Feasibility Study
Primary Purpose
Aortic Stenosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Centering Guide Catheter
Sponsored by
About this trial
This is an interventional device feasibility trial for Aortic Stenosis
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Self-Centering Guide Catheter
Arm Description
Subjects who provided written informed consent and an attempt is made to insert the Self-Centering Guide Catheter into the subject's femoral artery.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02639494
First Posted
December 17, 2015
Last Updated
August 27, 2018
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02639494
Brief Title
Self-Centering Guide Catheter Feasibility Study
Official Title
Self-Centering Guide Catheter Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 12, 2016 (Actual)
Primary Completion Date
October 6, 2016 (Actual)
Study Completion Date
October 6, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-Centering Guide Catheter
Arm Type
Experimental
Arm Description
Subjects who provided written informed consent and an attempt is made to insert the Self-Centering Guide Catheter into the subject's femoral artery.
Intervention Type
Device
Intervention Name(s)
Self-Centering Guide Catheter
Primary Outcome Measure Information:
Title
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
Description
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
Other Pre-specified Outcome Measures:
Title
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
Title
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
Title
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
Title
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
Description
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
Title
Number of Self-Centering Guide Catheters With Device Success
Description
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
Title
Number of Participants With Stroke
Time Frame
72 hours post-procedure
Title
Number of Participants With Cardiac Tamponade
Time Frame
72 hours post-procedure
Title
Death, All-cause, Cardiovascular, and Non-cardiovascular
Time Frame
72 hours post-procedure
Title
Any Device-related Adverse Event
Time Frame
72 hours post-procedure
Title
Any Adverse Event Occurring While the Self-Centering Guide Catheter is in the Subject
Time Frame
72 hours post-procedure
Title
Number of Device Deficiencies Including But Not Limited to Failures, Malfunctions, Use Errors, Product Nonconformities, and Labeling Errors
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajiv Gulati, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Self-Centering Guide Catheter Feasibility Study
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