Valvuloplasty Scoring Balloon Catheter First-in-Man Study

NCT01514994 | Completed

• 1 other identifier: ST-1486
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

AngioScore's Valvuloplasty Scoring Balloon

EXPERIMENTAL

Device: AngioScore's Valvuloplasty Scoring Balloon

Interventions

AngioScore's Valvuloplasty Scoring Balloon DEVICE

All patients will receive treatment for their aortic valve stenosis with the Valvuloplasty Scoring Balloon Catheter.

AngioScore's Valvuloplasty Scoring Balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Spectranetics Corporation: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• John G. Webb, MD

  St. Paul's Hospital, Vancouver, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2012
• First Posted: January 23, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: September 1, 2015
• Last Updated: April 18, 2016

Record last verified: 2016-04

Locations

CA (1)