CompletedNot Applicable

Paravalvular Leak for Transcatheter Valve Replacement

United States12 participantsStarted 2014-01

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged ≥18 years * Patients eligible for implantation of Edwards Sapien aortic valve. Exclusion Criteria: * 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

What they're measuring

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).

Timeframe: Up to 1 year +/- 60 days post TAVR.

Trial details

NCT IDNCT02079129

SponsorBaylor Research Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-07

View on ClinicalTrials.gov More Paravalvular Leak trials