Status:
UNKNOWN
Stent Implantation of Polyurethane Expandable Valve, by Catheter, in Patients With Pulmonary Valve Dysfunction
Lead Sponsor:
Dr. Miguel Angel Maluf
Collaborating Sponsors:
SYNTHETIC HEART TECHNOLOGY
Conditions:
Valvulopathy
Eligibility:
All Genders
18+ years
Phase:
NA
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 dysf...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05289622
Start Date
October 1 2022
End Date
February 1 2023
Last Update
April 1 2022
Active Locations (1)
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1
Hospital Alemão Oswaldo Cruz
São Paulo, Brazil, 01327-001