Self-Centering Guide Catheter Feasibility Study

Aortic Stenosis Clinical Trial

Official title:

Self-Centering Guide Catheter Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02639494
• Other study ID #: S2360
• Status: Completed
• Phase: N/A
• Start date: May 12, 2016
• Est. completion date: October 6, 2016

Study information

• Verified date: August 2018
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 6, 2016
• Est. primary completion date: October 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

Intervention

Device:
• Self-Centering Guide Catheter

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Number of Participants With Stroke		72 hours post-procedure
Other	Number of Participants With Cardiac Tamponade		72 hours post-procedure
Other	Death, All-cause, Cardiovascular, and Non-cardiovascular		72 hours post-procedure
Other	Any Device-related Adverse Event		72 hours post-procedure
Other	Any Adverse Event Occurring While the Self-Centering Guide Catheter is in the Subject		72 hours post-procedure
Other	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
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.	Through study completion, up to 72 hours post-procedure