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

Completed

• Conditions: Structural and Valvular Heart Disease

• Registration Number: NCT01669551
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Status Verified: 2012-08
• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-21
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-08
• Last Update Posted: 2014-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of volume intracardiac echo imaging to 2 dimensional echo	Comparison study