CompletedNot Applicable

Evaluation of the Usefulness of Imaging Methods and 3D Reconstruction in Percutaneous Closure Procedures of PVL.

Poland18 participantsStarted 2017-05-08

Plain-language summary

Paravalvular leak (PVL) is a condition that could be treated surgically or by the transcatheter deployment of the occluder devices (plugs). No PVL-specific occluder device is available on the market. VALE consortium plans to design and validate a new PVL dedicated devices (sizing balloon and occluder) in the context of computer 3D modeling, bench testing, preclinical evaluation and clinical research.

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: * The presence of clinically and haemodynamically significant leakage around the surgically implanted cardiac prosthesis in the mitral or aortic position. * Heart surgery (heart team) disability after another cardiac surgery. * Technical feasibility of paravalvular leakage closure according to experienced operator. Exclusion Criteria: * Active endocarditis on artificial valve * Instability of artificial valve * The amount of cavity that prevents effective closure with an occluder * A history of acute coronary syndrome in less than 3 months before enrollment * Confirmed echocardiography of transplatin or transesophageal echocardiography * Hypersensitivity to contrast media * Any condition associated with the expected life expectancy of less than 6 months * Haemorrhagic diathesis * Significant renal impairment (eGFR \<30 mL/min/1.73m2)/chronic kidney disease at \>G3 stage * Pregnancy or lactation * Under 18 years of age * Patient unable or unwilling to give an informed consent to participate in the study

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

Number of subjects with sizing procedure success (efficacy outcome)

Timeframe: During index procedure

Incidence of a combined investigational device safety endpoint (safety outcome)

Timeframe: During index procedure

Trial details

NCT IDNCT03371472

SponsorBalton Sp.zo.o.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-06-12

View on ClinicalTrials.gov More PVL - Paravalvular Leak trials