Clinical trial NCT02639494: Self-Centering Guide Catheter Feasibility Study
Official title: Self-Centering Guide Catheter Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Stenosis
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2015-12-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Primary outcomes:
measure: 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
timeFrame: Through study completion, up to 72 hours post-procedure
Secondary outcomes:
Other outcomes:
measure: 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
timeFrame: Through study completion, up to 72 hours post-procedure
measure: Time From Insertion of the Self-Centering Guide Catheter Into the Body to Removal of the Self-Centering Guide Catheter From the Body
timeFrame: Through study completion, up to 72 hours post-procedure
measure: Number of Attempts Made to Cross the Stenotic Native Aortic Valve With a PTFE-coated Guidewire
timeFrame: Through study completion, up to 72 hours post-procedure
measure: 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
timeFrame: Through study completion, up to 72 hours post-procedure
measure: Number of Self-Centering Guide Catheters With Device Success
timeFrame: Through study completion, up to 72 hours post-procedure
measure: Number of Participants With Stroke
timeFrame: 72 hours post-procedure
measure: Number of Participants With Cardiac Tamponade
timeFrame: 72 hours post-procedure
measure: Death, All-cause, Cardiovascular, and Non-cardiovascular
timeFrame: 72 hours post-procedure
measure: Any Device-related Adverse Event
timeFrame: 72 hours post-procedure
measure: Any Adverse Event Occurring While the Self-Centering Guide Catheter is in the Subject
timeFrame: 72 hours post-procedure
measure: Number of Device Deficiencies Including But Not Limited to Failures, Malfunctions, Use Errors, Product Nonconformities, and Labeling Errors
timeFrame: 72 hours post-procedure
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Rajiv Gulati, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: