Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement (BAV-SAVR)

University of California (UC) Davis

Status: Completed

Conditions: Aortic Stenosis

Study type: Observational

Funder types: Other

Identifiers

NCT00584116

200614760

Details and patient eligibility

About

Prospective, two academic center, non-randomized pilot, acute in-patient study correlating pre-operative imaging studies, intra-operative measurements and intra-operative balloon aortic valvuloplasty (BAV) in patients with degenerative aortic stenosis undergoing surgical aortic valve replacement (SAVR) to understand the requirements (device size and radial strength) of emerging percutaneous heart valve technologies in the treatment of aortic stenosis.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older

• Any patient with severe, symptomatic calcific aortic stenosis (AS) referred for elective surgical aortic valve replacement.

  • Severe AS: aortic valve area (AVA) ≤ 1.0 cm2
  • Symptoms: dyspnea on exertion, heart failure, angina or syncope believed to be secondary to AS

Exclusion criteria

• Emergent surgical aortic valve replacement.
• Inability to undergo TTE or TEE intra-operatively.
• Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.