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 Pennsylvania30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Structural and Valvular Heart Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Comparison of volume intracardiac echo imaging to 2 dimensional echo

Time frame: Comparison study

Data from ClinicalTrials.gov