UnknownNot Applicable

Stent Implantation of Polyurethane Expandable Valve, by Catheter, in Patients With Pulmonary Valve Dysfunction

Brazil5 participantsStarted 2022-10

Plain-language summary

Prospective Study, Single Arm to evaluate the safety and efficacy of polyurethane expandable valve implantation in the pulmonary position, in 5 patients over 18 years of age, with pulmonary valve dysfunction and moderate to severe impairment of Right Ventricular function. During throughout the study, safety parameters related to valve operation will be evaluated (patient's Functional Class), in addition to the occurrence of Serious Adverse Events. After the procedure, the patient must be hospitalized in the Intensive Care Unit until the complete hemodynamic stabilization and normalization of lung function and in good general condition (2 to 3 days of stay) and then transferred to the ward (2 to 3 days and stay) before hospital discharge. A formal Statistical Analysis Plan (SAP) will be developed and finalized before closing the database. Full details of data presentations and analysis will be provided in SAP. Additional statistical analyses, other than those described in this section, may be performed if deemed appropriate and included in SAP. Any deviations from the final analysis plan or what is presented in the protocol will be discussed in the final study report. No formal inferential statistics will be applied to the data collected in the study.

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 or older; * Pulmonary valve dysfunction and moderate to severe impairment of Right Ventricle function; * Functional Class II to IV New York Heart Association (NYHA) classification of heart failure. Exclusion Criteria: * Impairment of cardiovascular function; * Neurological impairment; * Syndromes without prognosis or survival of less than 1 year; * Carriers of infection undergoing medical treatment; * Patients undergoing artificial life support; * Known hypersensitivity to aspirin or heparin; * Positive urine or serum test for pregnancy in female patients of reproductive age.

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

Pulmonary Regurgitation After Polyurethane Expandable Valve Stent Implant Surgery

Timeframe: 6 months

Trial details

NCT IDNCT05289622

SponsorDr. Miguel Angel Maluf

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12

Contact for this trial

Dayane Correa Vila Nova

+55 11 3549-0729 dvilanova@haoc.com.br

View on ClinicalTrials.gov More Valvulopathy trials