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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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