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

Single-arm Prospectus Study to Evaluate the Safety and Security of the Expandable Valve Stent, Approach Technique and Its Implantation in the Pulmonary Position

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Valvulopathy
• Intervention / Treatment: Device: Polyurethane expandable valve stent implant

• Study Type: Interventional
• Enrollment (Anticipated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dayane Correa Vila Nova; Phone Number: +55 11 3549-0729; Email: dvilanova@haoc.com.br

Study Locations

• Brazil
  • São Paulo, Brazil, 01327-001
    • Hospital Alemao Oswaldo Cruz
    • Contact: Dayane Correa Vila Nova; Phone Number: +55 11 3549-0729; Email: dvilanova@haoc.com.br
    • Principal Investigator: Miguel Maluf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Polyurethane expandable valve stent implant surgery; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dr. Miguel Angel Maluf
• Collaborators: SYNTHETIC HEART TECHNOLOGY
• Investigators: Principal Investigator: Miguel Angel Maluf, Hospital Alemao Oswaldo Cruz

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Prosthesis; Tetralogy of Fallot; heart diseases; right ventricular dysfunction; pulmonary valve dysfunction; pulmonary valvulopathy; Stent implant; Pulmonary valve disorders; Polyurethane Expandable Valve Stent; Cardiac insufficiency; Pulmonary Valve Insufficiency
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases
• Other Study ID Numbers: 43624621.7.0000.0070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: A representative appointed by the study sponsor, regulatory authorities, or other auditing bodies whose job it is to verify that the research is being conducted properly may review any study data and records maintained by the study physician at the research site only, maintaining the privacy and anonymity of each participant.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes