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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: AngioScore's Valvuloplasty Scoring Balloon

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
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z1Y6
      • St. Paul's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Spectranetics Corporation
• Investigators: Principal Investigator: John G. Webb, MD, St. Paul's Hospital, Vancouver, Canada

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: January 11, 2012
• First Submitted That Met QC Criteria: January 18, 2012
• First Posted (Estimate): January 23, 2012

Study Record Updates

• Last Update Posted (Estimate): April 18, 2016
• Last Update Submitted That Met QC Criteria: April 15, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: ST-1486