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Valvuloplasty Scoring Balloon Catheter First-in-Man Study

This study has been completed.
Information provided by (Responsible Party):
Spectranetics Corporation Identifier:
First received: January 11, 2012
Last updated: April 15, 2016
Last verified: April 2016
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 Intervention
Aortic Valve Stenosis Device: AngioScore's Valvuloplasty Scoring Balloon

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Spectranetics Corporation:

Primary Outcome Measures:
  • 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.

  • 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

Enrollment: 25
Study Start Date: June 2012
Study Completion Date: September 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01514994

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

Responsible Party: Spectranetics Corporation Identifier: NCT01514994     History of Changes
Other Study ID Numbers: ST-1486
Study First Received: January 11, 2012
Last Updated: April 15, 2016

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction processed this record on August 17, 2017