Status:
COMPLETED
Valvuloplasty Scoring Balloon Catheter First-in-Man Study
Lead Sponsor:
Spectranetics Corporation
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 Cathete...
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 stand...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01514994
Start Date
June 1 2012
End Date
September 1 2015
Last Update
April 18 2016
Active Locations (1)
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1
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z1Y6