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Valvuloplasty Scoring Balloon Catheter First-in-Man Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Spectranetics Corporation
ClinicalTrials.gov Identifier:
NCT01514994
First received: January 11, 2012
Last updated: April 15, 2016
Last verified: April 2016

January 11, 2012
April 15, 2016
June 2012
December 2014   (final data collection date for primary outcome measure)
  • Procedural Success [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Freedom from in-hospital death, stroke, myocardial infarction or emergency cardiac surgery
Same as current
Complete list of historical versions of study NCT01514994 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Valvuloplasty Scoring Balloon Catheter First-in-Man Study
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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Aortic Valve Stenosis
Device: AngioScore's Valvuloplasty Scoring Balloon
All patients will receive treatment for their aortic valve stenosis with the Valvuloplasty Scoring Balloon Catheter.
Experimental: AngioScore's Valvuloplasty Scoring Balloon
Intervention: Device: AngioScore's Valvuloplasty Scoring Balloon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
September 2015
December 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01514994
ST-1486
No
Not Provided
Not Provided
Spectranetics Corporation
Spectranetics Corporation
Not Provided
Principal Investigator: John G. Webb, MD St. Paul's Hospital, Vancouver, Canada
Spectranetics Corporation
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP