ValvulopathyNCT05289622
Stent Implantation of Polyurethane Expandable Valve, by Catheter, in Patients With Pulmonary Valve Dysfunction
A study testing Polyurethane expandable valve stent implant in people with Valvulopathy, run by Dr. Miguel Angel Maluf at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valvulopathy
- What is being tested?
- Polyurethane expandable valve stent implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2022to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Alemão Oswaldo Cruz
São Paulo, 01327-001
Dayane Correa Vila Nova, +55 11 3549-0729, dvilanova@haoc.com.br
Miguel Maluf
About this study
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
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
- Being tested
- Polyurethane expandable valve stent implant
- 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
- Medical subject headings
- Heart Valve Diseases, Tetralogy of Fallot, Heart Failure, Ventricular Dysfunction, Right, Pulmonary Valve Insufficiency, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyurethane expandable valve stent implantDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Polyurethane expandable valve stent implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study startOct 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ValvulopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Miguel Angel Maluf
- Sponsor type
- University, hospital or other
- Collaborators
- SYNTHETIC HEART TECHNOLOGY
- Responsible party
- Sponsor-investigator, Dr. Miguel Angel Maluf, Hospital Alemão Oswaldo Cruz
- Investigators
- Miguel Angel Maluf, Principal investigator, Hospital Alemão Oswaldo Cruz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289622
- Sponsor's protocol ID
- 43624621.7.0000.0070
- Status last verified
- Mar 2022
- First submitted
- 11 Mar 2022
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05289622
- Acronym / sponsor ID
- 43624621.7.0000.0070
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Dr. Miguel Angel MalufUniversity, hospital or other
- Collaborators
- SYNTHETIC HEART TECHNOLOGY
- Study start
- Oct 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Polyurethane expandable valve stent implant surgery | Experimental | Device: Polyurethane expandable valve stent implantValve stent implantation will be performed under general anesthesia with transesophageal echocardiography monitoring, with thoracotomy approach median and circulation aid extracorporeal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyurethane expandable valve stent implantThe 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). | Device | Polyurethane expandable valve stent implant surgery |
Primary outcome
Pulmonary Regurgitation After Polyurethane Expandable Valve Stent Implant Surgery
Time frame: 6 months
if there are changes in pulmonary regurgitation (PR): discreet or less (≤2+) on transthoracic echocardiogram (TTE).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Angel Maluf principal investigator
Hospital Alemão Oswaldo Cruz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyurethane expandable valve stent implant in people with Valvulopathy, run by Dr. Miguel Angel Maluf at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dayane Correa Vila Nova (+55 11 3549-0729, dvilanova@haoc.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Regurgitation After Polyurethane Expandable Valve Stent Implant Surgery (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.