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

Dr. Miguel Angel Maluf

Status: Unknown

Conditions: Valvulopathy

Treatments: Device: Polyurethane expandable valve stent implant

Study type: Interventional

Funder types: Other

Identifiers

NCT05289622

43624621.7.0000.0070

Details and patient eligibility

About

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.

Enrollment: 5 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Polyurethane expandable valve stent implant surgery

Experimental group

Description:

Valve stent implantation will be performed under general anesthesia with transesophageal echocardiography monitoring, with thoracotomy approach median and circulation aid extracorporeal.

Treatment:

Device: Polyurethane expandable valve stent implant