CompletedNot Applicable

Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech PLD Device

Italy144 participantsStarted 2016-10

Plain-language summary

Collect patient data and to monitor the clinical use (safety and efficacy) of the device

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 with PVL associated hemolysis, recurrent blood transfusions, or hemodynamically significant heart failure Exclusion criteria The device is contraindicated for patients known to have any of the following: * Known coagulation dysfunction * Leak reversal with separate or significant residual or recurrent leak * Acute infection * Known intra-cardiac thrombi * Recent pelvic venous thrombosis * Recent myocardial infarction or a surgical bypass operation in the last 30 days * If adequate oral anticoagulation therapy / antiplatelet aggregation inhibition is not possible post-procedurally * Intolerance of contrast agent

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

Proper closure of the PVL (defined as Reduction in paravalvular regurgitation of ≥ one grade as assessed by echocardiography pre vs post implantation) and/or reduction in the number of hemolysis related transfusions.

Timeframe: 6 month following implantation

Absence of device -and/or procedure-related Serious Adverse Events (SAEs) including deaths, stroke (ischemic stroke that occurs within 24 hours following implantation), systemic embolism or device embolizations.

Timeframe: 6 month following implantation

Trial details

NCT IDNCT03003481

SponsorOcclutech International AB

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-05

View on ClinicalTrials.gov More Mitral Paravalvular Leaks (PVL) 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.

What they're measuring

Timeframe: 6 month following implantation