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Valvuloplasty Scoring Balloon Catheter First-in-Man Study

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ClinicalTrials.gov Identifier: NCT01514994
Recruitment Status : Completed
First Posted : January 23, 2012
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
Spectranetics Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: AngioScore's Valvuloplasty Scoring Balloon Not Applicable

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  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Critical Aortic Valve Stenosis Using a Novel Valvuloplasty Scoring Balloon Catheter: a First-in-Man Study
Study Start Date : June 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT01514994


Locations
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z1Y6
Sponsors and Collaborators
Spectranetics Corporation
Investigators
Principal Investigator: John G. Webb, MD St. Paul's Hospital, Vancouver, Canada

Responsible Party: Spectranetics Corporation
ClinicalTrials.gov Identifier: NCT01514994     History of Changes
Other Study ID Numbers: ST-1486
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction