Native Right Ventricle Outflow Tract(RVOT) DysfunctionNCT07531303
VenusP-Valve™ System Long-term Follow-up 6-10 Years
An observational study of Native Right Ventricle Outflow Tract(RVOT) Dysfunction, run by Venus MedTech (HangZhou) Inc..
Trial summary
The goal of this study is to assess the long-term safety, efficacy and performance of VenusP-Valve™ implantation. in all subjects who provided informed consent and received VenusP-Valve™ implantation in the VenusP-Valve™ system CE registration study (Protocol ID Number: VMT-001CE; NCT02846753). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Native Right Ventricle Outflow Tract(RVOT) Dysfunction
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All subjects who provided informed consent and received VenusP-Valve™ implantation in the VenusP-Valve™ system CE registration study (Protocol ID Number: VMT-001CE; NCT02846753).
Who may be able to join
- 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
Who cannot join
- The investigators consider that the patients are not suitable to participate in this study.
About this study
Official title: Long-term Follow-up Study of Implantation of the VenusP-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts
The goal of this study is to assess the long-term safety, efficacy and performance of VenusP-Valve™ implantation. in all subjects who provided informed consent and received VenusP-Valve™ implantation in the VenusP-Valve™ system CE registration study (Protocol ID Number: VMT-001CE; NCT02846753).
Annual clinic visits will be conducted from year 6 through year 10 post-implantation, including transthoracic echocardiography, New York Heart Association (NYHA) functional classification assessment, adverse event evaluation, and review of cardiovascular medication use at each visit..
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular reverse remodeling and improvement rate of right ventricular function were followed up at 6 months after operation
The right ventricular reverse remodeling and the improvement rate of right ventricular function at 6 months after operation were defined as the 6-month follow-up The right ventricular end-diastolic volume index measured by CMR was within the normal range, that is, RVEDVI≤108mL/m2.
Measured: From enrollment to month-6 post procedure.
Secondary outcomes (1)
adverse events and moderate or greater pulmonary regurgitation at 6 years, 7 years, 8 years, 9 years and 10 years.
- Occurrence of the following adverse events at 6 years, 7 years, 8 years, 9 years and 10 years:
- Device migration/embolization
- Valvar thrombosis
- Thromboembolism
- Bleeding
- Paravalvular leak
- Endocarditis
- Nonstructural dysfunction
- Explant
- Hemolysis
- Arrhythmias
- Moderate or greater pulmonary regurgitation by echocardiography at 6 years, 7 years, 8 years, 9 years and 10 years.
Measured: From enrollment to 10 years post procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Native Right Ventricle Outflow Tract(RVOT) DysfunctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Venus MedTech (HangZhou) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531303
- Sponsor's protocol ID
- VTPP-24-05
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up Study of Implantation of the VenusP-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts
- ClinicalTrials.gov ID
- NCT07531303
- Acronym / sponsor ID
- VTPP-24-05
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Venus MedTech (HangZhou) Inc.Industry (pharma, biotech, devices)
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 15 Apr 2026 (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.
The goal of this study is to assess the long-term safety, efficacy and performance of VenusP-Valve™ implantation. in all subjects who provided informed consent and received VenusP-Valve™ implantation in the VenusP-Valve™ system CE registration study (Protocol ID Number: VMT-001CE; NCT02846753).
Annual clinic visits will be conducted from year 6 through year 10 post-implantation, including transthoracic echocardiography, New York Heart Association (NYHA) functional classification assessment, adverse event evaluation, and review of cardiovascular medication use at each visit..
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All subjects who provided informed consent and received VenusP-Valve™ implantation in the VenusP-Valve™ system CE registration study (Protocol ID Number: VMT-001CE; NCT02846753).
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- The investigators consider that the patients are not suitable to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Right ventricular reverse remodeling and improvement rate of right ventricular function were followed up at 6 months after operation
Time frame: From enrollment to month-6 post procedure.
The right ventricular reverse remodeling and the improvement rate of right ventricular function at 6 months after operation were defined as the 6-month follow-up The right ventricular end-diastolic volume index measured by CMR was within the normal range, that is, RVEDVI≤108mL/m2.
1 secondary outcome
adverse events and moderate or greater pulmonary regurgitation at 6 years, 7 years, 8 years, 9 years and 10 years.
Time frame: From enrollment to 10 years post procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Native Right Ventricle Outflow Tract(RVOT) Dysfunction, 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 15 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Right ventricular reverse remodeling and improvement rate of right ventricular function were followed up at 6 months after operation (time frame: From enrollment to month-6 post procedure.). 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 15 Apr 2026.