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Completed

NCT Number: NCT02639494

Self-Centering Guide Catheter Feasibility Study

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.

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Key information

Conditions

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

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Self-Centering Guide Catheter

Device

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

    Time frame: 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

    Time frame: 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.

  5. Number of Self-Centering Guide Catheters With Device Success

    Time frame: 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.

  6. Number of Participants With Stroke

    Time frame: 72 hours post-procedure

  7. Number of Participants With Cardiac Tamponade

    Time frame: 72 hours post-procedure

  8. Death, All-cause, Cardiovascular, and Non-cardiovascular

    Time frame: 72 hours post-procedure

  9. Any Device-related Adverse Event

    Time frame: 72 hours post-procedure

  10. Any Adverse Event Occurring While the Self-Centering Guide Catheter is in the Subject

    Time frame: 72 hours post-procedure

  11. Number of Device Deficiencies Including But Not Limited to Failures, Malfunctions, Use Errors, Product Nonconformities, and Labeling Errors

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 24, 2015
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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