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

NCT05289622 | Unknown FDA Device

• 1 other identifier: 43624621.7.0000.0070
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Polyurethane expandable valve stent implant surgery

EXPERIMENTAL

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

Device: Polyurethane expandable valve stent implant

Interventions

Polyurethane expandable valve stent implant DEVICE

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).

Polyurethane expandable valve stent implant surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Miguel Angel Maluf: lead
• SYNTHETIC HEART TECHNOLOGY: collaborator

Study Sites (1)

Hospital Alemão Oswaldo Cruz

São Paulo, 01327-001, Brazil

Location

MeSH Terms

Conditions

Heart Valve Diseases; Tetralogy of Fallot; Heart Failure; Ventricular Dysfunction, Right; Pulmonary Valve Insufficiency; Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ventricular Dysfunction

Study Officials

• Miguel Angel Maluf

  Hospital Alemão Oswaldo Cruz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dayane Correa Vila Nova

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 21, 2022
• Study Start: October 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: February 1, 2023
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)