Self-Centering Guide Catheter Feasibility Study

NCT02639494 | Completed Results FDA Device

• 1 other identifier: S2360
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (11)

• 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

  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

Study Arms (1)

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.

Device: Self-Centering Guide Catheter

Interventions

Self-Centering Guide Catheter DEVICE

Self-Centering Guide Catheter

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Dr. Rajiv Gulati
• Organization: Mayo Clinic

Gulati.Rajiv@mayo.edu

507-538-6325

Study Officials

• Rajiv Gulati, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: December 24, 2015
• Study Start: May 12, 2016
• Primary Completion: October 6, 2016
• Study Completion: October 6, 2016
• Last Updated: August 29, 2018
• Results First Posted: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)