Clinical trial NCT05289622: Stent Implantation of Polyurethane Expandable Valve, by Catheter, in Patients With Pulmonary Valve Dysfunction
Official title: Single-arm Prospectus Study to Evaluate the Safety and Security of the Expandable Valve Stent, Approach Technique and Its Implantation in the Pulmonary Position
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Valvulopathy
Keywords: pulmonary valve dysfunction
pulmonary valvulopathy
Stent implant
Pulmonary valve disorders
Polyurethane Expandable Valve Stent
Tetralogy of Fallot
Cardiac insufficiency
right ventricular dysfunction
Pulmonary Valve Insufficiency
heart diseases
Prosthesis
Lead sponsor: Hospital Alemão Oswaldo Cruz
Sponsor class: OTHER
Collaborators: name: SYNTHETIC HEART TECHNOLOGY
First posted: 2022-03-21
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, Single Arm Safety and Efficacy Study to evaluate the expandable polyurethane valve in the pulmonary position, in 5 patients over 18 years of age, with pulmonary valve dysfunction and moderate to severe impairment of cardiac ventricular function.
Primary purpose: DEVICE_FEASIBILITY

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pulmonary Regurgitation After Polyurethane Expandable Valve Stent Implant Surgery
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Alemão Oswaldo Cruz
Study officials:
affiliation: Hospital Alemão Oswaldo Cruz
name: Miguel Angel Maluf
role: PRINCIPAL_INVESTIGATOR
References: