Valvuloplasty Scoring Balloon Catheter First-in-Man Study

NCT ID: NCT01514994

Last Updated: 2016-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-09-30

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.

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.

Conditions

Aortic Valve Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AngioScore's Valvuloplasty Scoring Balloon

Group Type: EXPERIMENTAL

AngioScore's Valvuloplasty Scoring Balloon

Intervention Type: DEVICE

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

Interventions

AngioScore's Valvuloplasty Scoring Balloon

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

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spectranetics Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John G. Webb, MD

Role: PRINCIPAL_INVESTIGATOR

St. Paul's Hospital, Vancouver, Canada

Locations

St. Paul's Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

ST-1486

Identifier Type: -

Identifier Source: org_study_id