Paravalvular Leak for Transcatheter Valve Replacement

Completed

Conditions studied: Paravalvular Leak, Transcatheter Valve Replacement

In brief

The study objective is to assess the agreement between cMRI PVL grading (based on regurgitant fraction) and TTE PVL grading (based on pressure half-time and the ratio of the jet arc to the circumference of the annulus).

Key facts

Study ID

NCT02079129

Run by

Baylor Research Institute

People needed

12

Starts

2014-01-01

Expected to finish

2018-07-01

Last updated by the study team

2020-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged ≥18 years
• Patients eligible for implantation of Edwards Sapien aortic valve.

You may not qualify if…

• Pregnancy-Women of childbearing potential should have negative urine pregnancy test prior to enrollment
• Patients with implanted pacemaker
• Patients with implantable cardiac defibrillator
• Patients with contraindication to MRI
• Medically unable to provide consent
• Any surgical prosthesis
• Moderate or severe mitral regurgitation
• Central aortic valve leak

Where it is running

• The Heart Hospital Baylor — Plano, Texas, United States

Full record on ClinicalTrials.gov

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