Valvuloplasty Scoring Balloon Catheter First-in-Man Study

April 15, 2016 updated by: Spectranetics Corporation

Treatment of Critical Aortic Valve Stenosis Using a Novel Valvuloplasty Scoring Balloon Catheter: a First-in-Man Study

The Valvuloplasty Scoring Balloon First-in-Man study is a prospective, single arm, two phase, observational registry to demonstrate the safety and efficacy of the Valvuloplasty Scoring Balloon Catheter for the treatment of critical aortic valve stenosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Phase 1 will enroll patient who are scheduled to undergo open surgical aortic valve replacement and will have the Valvuloplasty Scoring Balloon delivered to their stenotic aortic valve through a standard aortotomy and deployed immediately prior to valve replacement.

Phase 2 will enroll patients with aortic valve stenosis who are deemed to not be suitable candidates for elective surgical aortic valve replacement and in whom the investigational Valvuloplasty Scoring Balloon will be used as a stand-alone Valvuloplasty procedure or "bridge" to trans-catheter aortic valve implantation (TAVI) or surgery.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z1Y6
        • St. Paul's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Native, degenerative-calcific, tricuspid, aortic valve stenosis with echocardiographic derived criteria: mean gradient of >40 mm Hg or Doppler peak systolic velocity greater than 4.0 m/s or an initial aortic valve area < 0.8 cm2.
  • Symptomatic aortic valve disease as demonstrated by CCS Functional Class II or greater
  • Aortic valve annulus of greater than or equal to 18 mm and less than or equal to 28 mm measured on pre-procedure TTE.
  • Phase 1 patients must be scheduled for a surgical aortic valve replacement.
  • Phase 2 patients must not be suitable candidates for elective surgical aortic valve replacement.

Exclusion Criteria:

  • Recent myocardial infarction (<30days)
  • Unicuspid or bicuspid aortic valve or non-calcific aortic valve stenosis
  • Any sepsis, including active endocarditis
  • Concomitant 2+ or greater aortic valve valve regurgitation
  • LVEF < 20%
  • CVA or TIA within the previous 6 months
  • Previous aortic valve replacement (bioprosthetic or mechanical)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AngioScore's Valvuloplasty Scoring Balloon
Device: AngioScore's Valvuloplasty Scoring Balloon
All patients will receive treatment for their aortic valve stenosis with the Valvuloplasty Scoring Balloon Catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural Success
Time Frame: 1 day
Procedural success defined as a >50% increase in the aortic valve effective orifice area and less than or equal to 2+ valvular regurgitation at the end of the percutaneous valvuloplasty procedure utilizing echocardiography, hemodynamic measurements and angiography.
1 day
Number of participants who do not experience death, stroke, myocardial infarction or emergency cardiac surgery during their hospitalization.
Time Frame: Participants will be followed for the duration of the hospital stay, an expected average of 48 hours
Freedom from in-hospital death, stroke, myocardial infarction or emergency cardiac surgery
Participants will be followed for the duration of the hospital stay, an expected average of 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectranetics Corporation

Investigators

  • Principal Investigator: John G. Webb, MD, St. Paul's Hospital, Vancouver, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 11, 2012

First Submitted That Met QC Criteria

January 18, 2012

First Posted (Estimate)

January 23, 2012

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST-1486

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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