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

Valvulopathy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05289622
• Other study ID #: 43624621.7.0000.0070
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2022
• Est. completion date: February 2023

Study information

• Verified date: March 2022
• Source: Hospital Alemão Oswaldo Cruz
• Contact: Dayane Correa Vila Nova
• Phone: +55 11 3549-0729
• Email: dvilanova[@]haoc.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5
• Est. completion date: February 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Valve Diseases
• Valvulopathy

Intervention

Device:
• Polyurethane expandable valve stent implant
The baseline assessment of patients will include the admission of patients and the performance of preoperative exams (cardiological imaging for the correct selection). An estimated surgery time of 5 hours. During the entire procedure, patients will be under general anesthesia and controlled mechanical ventilation. The material collected in the laboratory will be processed, the result released and discarded. After the patient enters the operating room, hemodynamic monitoring, ECG, arterial saturation, with peripheral sensor, central venous access with double lumen catheter will be carried out; blood pressure monitoring by radial artery puncture, bladder catheter and thermometer in the nasopharynx and rectum. After preoperative preparation, patients will undergo a surgical approach by median thoracotomy and installation of the Cardiopulmonary bypass (ECC) circuit, by placing a cannula in the ascending aorta, Superior Vena Cava (SVC) and Inferior Vena Cava (IVC).

Locations

Country	Name	City	State
Brazil	Hospital Alemão Oswaldo Cruz	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Miguel Angel Maluf	SYNTHETIC HEART TECHNOLOGY

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Regurgitation After Polyurethane Expandable Valve Stent Implant Surgery	if there are changes in pulmonary regurgitation (PR): discreet or less (=2+) on transthoracic echocardiogram (TTE).	6 months