Valvuloplasty Scoring Balloon Catheter First-in-Man Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of Critical Aortic Valve Stenosis Using a Novel Valvuloplasty Scoring Balloon Catheter: a First-in-Man Study

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: AngioScore's Valvuloplasty Scoring Balloon


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AngioScore's Valvuloplasty Scoring Balloon<br> | Device: AngioScore's Valvuloplasty Scoring Balloon<br>* All patients will receive treatment for their aortic valve stenosis with the Valvuloplasty Scoring Balloon Catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | 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. | 1 day | 
| Number of participants who do not experience death, stroke, myocardial infarction or emergency cardiac surgery during their hospitalization. | Freedom from in-hospital death, stroke, myocardial infarction or emergency cardiac surgery | Participants will be followed for the duration of the hospital stay, an expected average of 48 hours |