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Self-Centering Guide Catheter Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02639494
Recruitment Status : Completed
First Posted : December 24, 2015
Results First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment Phase
Aortic Stenosis Device: Self-Centering Guide Catheter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Self-Centering Guide Catheter Feasibility Study
Actual Study Start Date : May 12, 2016
Actual Primary Completion Date : October 6, 2016
Actual Study Completion Date : October 6, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Self-Centering Guide Catheter
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



Primary Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639494


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Rajiv Gulati, MD, PhD Mayo Clinic
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02639494    
Other Study ID Numbers: S2360
First Posted: December 24, 2015    Key Record Dates
Results First Posted: August 29, 2018
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction