A Phase 1 Feasbility Study Of Volume Intracardiac Echo In Assessment Of Patients With Structural And Valvular Heart Disease Undergoing Percutaneous Transcatheter Therapy

University of Pennsylvania

Status: Completed

Conditions: Structural and Valvular Heart Disease

Study type: Observational

Funder types: Other

Identifiers

NCT01669551

UPenn 815656

Details and patient eligibility

About

This study will compare 3 dimensional intracardiac echo (ICE) with 2 dimensional ICE or transesophageal echo in patients with structural and valvular heart disease who are already scheduled to undergo a percutaneous intervention. Specifically those patients would be those scheduled for a PFO or ASD repair, mitral balloon valvuloplasty, diagnostic cardiac catheterization assessment of aortic stenosis and those undergoing transcatheter aortic valve replacement.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients in the study population referred to the cardiac catheterization laboratory for a percutaneous procedure to treat structural or valvular heart disease

Exclusion criteria

• Class IV CHF, inadequate femoral access, coagulation abnormalities, intracariac thrombus or DVT

Trial design

30 participants in 1 patient group

Structural or Valvular Heart Disease