Valvuloplasty Scoring Balloon Catheter First-in-Man Study

Aortic Valve Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514994
• Other study ID #: ST-1486
• Status: Completed
• Phase: N/A
• First received: January 11, 2012
• Last updated: April 15, 2016
• Start date: June 2012
• Est. completion date: September 2015

Study information

• Verified date: April 2016
• Source: Spectranetics Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• AngioScore's Valvuloplasty Scoring Balloon
All patients will receive treatment for their aortic valve stenosis with the Valvuloplasty Scoring Balloon Catheter.

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Spectranetics Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes