Valvuloplasty Scoring Balloon Catheter First-in-Man Study

Spectranetics

Status

Completed

Conditions

Aortic Valve Stenosis

Treatments

Device: AngioScore's Valvuloplasty Scoring Balloon

Study type

Interventional

Funder types

Industry

Identifiers

NCT01514994

ST-1486

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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