Brief Title
Valvuloplasty Scoring Balloon Catheter First-in-Man Study
Official Title
Treatment of Critical Aortic Valve Stenosis Using a Novel Valvuloplasty Scoring Balloon Catheter: a First-in-Man Study
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.
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
Primary Outcome
Procedural Success
Condition
Aortic Valve Stenosis
Intervention
AngioScore's Valvuloplasty Scoring Balloon
Study Arms / Comparison Groups
AngioScore's Valvuloplasty Scoring Balloon
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
25
Start Date
June 2012
Completion Date
September 2015
Primary Completion Date
December 2014
Eligibility 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)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
John G. Webb, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT01514994
Organization ID
ST-1486
Responsible Party
Sponsor
Study Sponsor
Spectranetics Corporation
Study Sponsor
John G. Webb, MD, Principal Investigator, St. Paul's Hospital, Vancouver, Canada
Verification Date
April 2016