Pulmonary RegurgitationNCT02846753
Implantation of the Venus P-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts
A study testing trans catheter heart valve replacement in people with Pulmonary Regurgitation, run by Venus MedTech (HangZhou) Inc..
Trial summary
A prospective, non-randomized multi-center clinical investigation of the Venus P-Valve™ for the treatment of pulmonary regurgitation with or without stenosis in patient with native outflow tracts. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Pulmonary Regurgitation
- What is being tested?
- trans catheter heart valve replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 17 Aug 2016to 31 Dec 2024
- 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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Candidates for this study must meet all of the following Inclusion criteria:
- Age: range from 12-70 years of age
- Weight must be "equal to" or exceed 30 kilograms
- Subject presents with evidence of moderate or severe (≥3+) pulmonary regurgitation by TTE
- Subject presents with >30% pulmonary regurgitation fraction as defined by cardiac MRI
- Subject is symptomatic from his/her pulmonary regurgitation or meets MRI criteria for intervention: right ventricular ejection fraction (RVEF) < 45%, pulmonary regurgitant fraction (PRRF) >30% and increased right ventricular end-diastolic volume (RVEDV) >150ml/m2
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- Subject will comply with specified follow-up evaluations, including echocardiograms and MRI
- The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the ethics committee and regulatory authority if applicable of the respective clinical site
- The subject and the treating physician agree that the subject will return for all required post-procedure follow up visits
- Catheterization is determined to be feasible by the treating physician
Who cannot join
- Candidates will be excluded from the study if any of the following conditions are present:
- Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics)
- Severe chest wall deformity
- Leukopenia (WBC<3000 mm3)
- Acute or chronic anemia (Hb <90g/l)
- Platelet count <100,000 cells/mm3
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- In the judgment of the investigator, percutaneous introduction and delivery of the valve is not feasible
- Need for emergency cardiac or vascular surgery, including pulmonary embolectomy, for any reason
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- History of, or active, endocarditis, unless the endocarditis has been treated >6 months previous to the procedure
- History of or current intravenous drug abuse
- A known hypersensitivity to aspirin or heparin
- Currently participating in an investigational drug or another device study [Note: Trials requiring extended follow up for products that were investigational, but have since become commercially available, are not considered investigational devices.]
- Major or progressive non-cardiac disease resulting in a life expectancy of <1yr
- Obstruction of the central veins preventing advancement of the pulmonary bioprosthesis delivery system to the heart
- Positive urine or serum pregnancy test in female subjects of child-bearing potential
- Ileofemoral vessel characteristics that would preclude safe placement of 19 French (F), 22 F and 24 F introducer sheath
- Contraindication for cardiac magnetic resonance imaging or inability to cooperate with a cardiac magnetic resonance imaging exam
- Need for concomitant interventional procedures
About this study
A prospective, non-randomized multi-center clinical investigation of the Venus P-Valve™ for the treatment of pulmonary regurgitation with or without stenosis in patient with native outflow tracts.
Read the detailed description
This study evaluates the implantation of the Venus P-Valve™ for the treatment of patients with an incompetent pulmonic valve, which causes blood to flow back from the pulmonary artery into the right heart ventricle during pumping of the heart (pulmonary regurgitation). Patients with and without narrowing (stenosis) of the right ventricular outflow tract will be included. The purpose of this protocol is to assess the safety and performance of Venus P-Valve™ implantation.
Post-procedure, a clinical visit will be scheduled at 30 days, 6 month, 12 months, and annually thereafter to 3 years. Population: Patients≥12 years with a body weight of ≥30kg, with significant pulmonary regurgitation (≥3+) with or without right ventricular outflow tract (RVOT) stenosis (mean Doppler gradient ≥35mmHg) with native right ventricular outflow tracts.
- Conditions
- Pulmonary Regurgitation
- Being tested
- trans catheter heart valve replacement
- Medical subject headings
- Pulmonary Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans catheter heart valve replacementProcedure or surgery
trans catheter heart valve replacement
| Study group | Role | What they receive |
|---|---|---|
| Implantation of Venus P-Valve™ | Experimental | Implantation of the Venus P-Valve™ in the pulmonic position in patients with native outflow tracts; trans catheter heart valve replacement. Receives: Procedure: trans catheter heart valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Venus P-Valve™ measured as probability of death/reoperation
Occurrence of death or reoperation (Valve and/or procedure related) calculated as a composite freedom-of-death and -reoperation probability at 12 months. The acceptance criterion for mortality and reoperation is 16% (or equivalently 84% freedom from death and reoperation). If the lower 95% confidence limit for survival and freedom from reoperation at 12 months is greater than 84%, the acceptance criterion for safety will have been met.
Measured: month 12 follow-up
Safety of Venus P-Valve™ measured as probability of Major Adverse Cardiac and Cerebro-vascular Event (MACCE)
Occurrence of MACCE (defined as death, myocardial infarction, reoperation, vascular injury resulting in the need for an unplanned vascular grafting intervention, stroke, and pulmonary embolism) calculated as freedom-from-MACCE probability at month-1, calculated using the Kaplan Meier method
Measured: month 1 follow-up
Performance of Venus P-Valve™ measured as Success rate of valve placement and implantation
The device success is defined as the percentage of subjects with successful implant of the P-Valve assessed at the earliest evaluable echocardiogram. Linearized rates will be presented.
Measured: up to 30 days
Hemodynamic Performance of Venus P-Valve™ measured as the mean transvalvular pressure (mmHg)
Hemodynamic performance, measured as the mean transvalvular pressure gradient measured by transthoracic echocardiogram at month-1
Measured: 1 month
Performance of Venus P-Valve™ measured as change of pulmonary regurgitation (regurgitation classification by MRI)
Improvement or abolition of pulmonary regurgitation assessed by MRI at baseline and month 6, with grading of pulmonary stenosis defined as: mild <2, moderate: 2-4; severe >4
Measured: baseline and month 6
Performance of Venus P-Valve™ measured as change of pulmonary regurgitation (regurgitation classification by transthoracic echocardiogram)
Improvement or abolition of pulmonary regurgitation assessed by transthoracic echocardiogram at baseline, day 1, month 1, 6, 12 and annually thereafter to 3 years post procedure, with grading of pulmonary stenosis defined as: mild <2, moderate: 2-4; severe >4
Measured: baseline, day 1, month 1, 6, 12 and annually thereafter to 3 years post procedure
Performance of Venus P-Valve™ measured as percentage of subjects with structural valve deterioration
Structural valve deterioration assessment includes stent fracture, leaflet mobility, thickening and calcification
Measured: month 6
Secondary outcomes (3)
Safety measured as percentage of subjects experiencing serious adverse events
Within the duration of the study of the percentage of patients experiencing the following events is measured:
- Device migration/embolization
- Valvar thrombosis
- Thromboembolism
- Bleeding
- Paravalvar leak
- Endocarditis
- Nonstructural dysfunction
- Explant
- Hemolysis
- Arrhythmias
- all other serious adverse events as defined in protocol section 6.2
Measured: up to third year of follow-up
Functional improvement measured as decreased pulmonary regurgitation (regurgitation classification by transthoracic echocardiogram )
Improved valve function demonstrated by a decrease in pulmonary regurgitation (PR) to mild or less (≤ 2) by transthoracic echocardiogram (TTE) at month-1
Measured: 1 month
Functional improvement measured as decreased pulmonary regurgitation (regurgitation classification by MRI)
Improved valve function demonstrated by a decrease in pulmonary regurgitation (PR) to mild or less (≤ 2) by MRI at month-6
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study start17 Aug 2016
- Primary completion31 Jul 2022
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary RegurgitationStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venus MedTech (HangZhou) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Inc., TheraGenesis, Intrials
- Responsible party
- Sponsor
- Investigators
- Shakeel A. Qureshi, MD, Principal investigator, Evelina Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846753
- Sponsor's protocol ID
- VMT-001CE
- Status last verified
- Apr 2023
- First submitted
- 3 May 2016
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The results of the study will be reported and disseminated in peer-reviewed scientific journals, internal reports, conference presentations and submissions to regulatory authorities. Nevertheless, all data used in the analysis and reporting of this clinical investigation will be without identifiable reference to individual patients. All the data will be anonymous.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation of the Venus P-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts
- ClinicalTrials.gov ID
- NCT02846753
- Acronym / sponsor ID
- VMT-001CE
- Conditions
- Pulmonary Regurgitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Venus MedTech (HangZhou) Inc.Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Inc., TheraGenesis, Intrials
- Study start
- 17 Aug 2016 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Jul 2016 (estimated)
- 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.
A prospective, non-randomized multi-center clinical investigation of the Venus P-Valve™ for the treatment of pulmonary regurgitation with or without stenosis in patient with native outflow tracts.
Detailed description
This study evaluates the implantation of the Venus P-Valve™ for the treatment of patients with an incompetent pulmonic valve, which causes blood to flow back from the pulmonary artery into the right heart ventricle during pumping of the heart (pulmonary regurgitation). Patients with and without narrowing (stenosis) of the right ventricular outflow tract will be included. The purpose of this protocol is to assess the safety and performance of Venus P-Valve™ implantation.
Post-procedure, a clinical visit will be scheduled at 30 days, 6 month, 12 months, and annually thereafter to 3 years. Population: Patients≥12 years with a body weight of ≥30kg, with significant pulmonary regurgitation (≥3+) with or without right ventricular outflow tract (RVOT) stenosis (mean Doppler gradient ≥35mmHg) with native right ventricular outflow tracts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation of Venus P-Valve™ | Experimental | Procedure: trans catheter heart valve replacementImplantation of the Venus P-Valve™ in the pulmonic position in patients with native outflow tracts; trans catheter heart valve replacement. |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Age: range from 12-70 years of age
- Weight must be "equal to" or exceed 30 kilograms
- Subject presents with evidence of moderate or severe (≥3+) pulmonary regurgitation by TTE
- Subject presents with >30% pulmonary regurgitation fraction as defined by cardiac MRI
- Subject is symptomatic from his/her pulmonary regurgitation or meets MRI criteria for intervention: right ventricular ejection fraction (RVEF) < 45%, pulmonary regurgitant fraction (PRRF) >30% and increased right ventricular end-diastolic volume (RVEDV) >150ml/m2
Key exclusion criteria (19 listed)
- Candidates will be excluded from the study if any of the following conditions are present:
- Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics)
- Severe chest wall deformity
- Leukopenia (WBC<3000 mm3)
- Acute or chronic anemia (Hb <90g/l)
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 |
|---|---|---|
| trans catheter heart valve replacementtrans catheter heart valve replacement | Procedure or surgery | Implantation of Venus P-Valve™ |
Primary outcome
Safety of Venus P-Valve™ measured as probability of death/reoperation
Time frame: month 12 follow-up
Occurrence of death or reoperation (Valve and/or procedure related) calculated as a composite freedom-of-death and -reoperation probability at 12 months. The acceptance criterion for mortality and reoperation is 16% (or equivalently 84% freedom from death and reoperation). If the lower 95% confidence limit for survival and freedom from reoperation at 12 months is greater than 84%, the acceptance criterion for safety will have been met.
Safety of Venus P-Valve™ measured as probability of Major Adverse Cardiac and Cerebro-vascular Event (MACCE)
Time frame: month 1 follow-up
Occurrence of MACCE (defined as death, myocardial infarction, reoperation, vascular injury resulting in the need for an unplanned vascular grafting intervention, stroke, and pulmonary embolism) calculated as freedom-from-MACCE probability at month-1, calculated using the Kaplan Meier method
Performance of Venus P-Valve™ measured as Success rate of valve placement and implantation
Time frame: up to 30 days
The device success is defined as the percentage of subjects with successful implant of the P-Valve assessed at the earliest evaluable echocardiogram. Linearized rates will be presented.
Hemodynamic Performance of Venus P-Valve™ measured as the mean transvalvular pressure (mmHg)
Time frame: 1 month
Hemodynamic performance, measured as the mean transvalvular pressure gradient measured by transthoracic echocardiogram at month-1
Performance of Venus P-Valve™ measured as change of pulmonary regurgitation (regurgitation classification by MRI)
Time frame: baseline and month 6
Improvement or abolition of pulmonary regurgitation assessed by MRI at baseline and month 6, with grading of pulmonary stenosis defined as: mild <2, moderate: 2-4; severe >4
Performance of Venus P-Valve™ measured as change of pulmonary regurgitation (regurgitation classification by transthoracic echocardiogram)
Time frame: baseline, day 1, month 1, 6, 12 and annually thereafter to 3 years post procedure
Improvement or abolition of pulmonary regurgitation assessed by transthoracic echocardiogram at baseline, day 1, month 1, 6, 12 and annually thereafter to 3 years post procedure, with grading of pulmonary stenosis defined as: mild <2, moderate: 2-4; severe >4
Performance of Venus P-Valve™ measured as percentage of subjects with structural valve deterioration
Time frame: month 6
Structural valve deterioration assessment includes stent fracture, leaflet mobility, thickening and calcification
3 secondary outcomes
Safety measured as percentage of subjects experiencing serious adverse events
Time frame: up to third year of follow-up
Functional improvement measured as decreased pulmonary regurgitation (regurgitation classification by transthoracic echocardiogram )
Time frame: 1 month
Functional improvement measured as decreased pulmonary regurgitation (regurgitation classification by MRI)
Time frame: month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Individual participant dataSharing planned: No. The results of the study will be reported and disseminated in peer-reviewed scientific journals, internal reports, conference presentations and submissions to regulatory authorities. Nevertheless, all data used in the analysis and reporting of this clinical investigation will be without identifiable reference to individual patients. All the data will be anonymous.
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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.
Shakeel A. Qureshi, MD principal investigator
Evelina Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing trans catheter heart valve replacement in people with Pulmonary Regurgitation, run by Venus MedTech (HangZhou) Inc..
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 10 inclusion and 19 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 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Venus P-Valve™ measured as probability of death/reoperation (time frame: month 12 follow-up). The study lists 7 primary outcomes in all. 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 21 Apr 2023.