A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve (METASAR)

July 4, 2023 updated by: Jilin Venus Haoyue Medtech Limited
The goal of this clinical trial is to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve in subjects who are clinically indicated for aortic valve replacement.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective, multicenter, non-randomized interventional study to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve. 155 subjects are estimated to be enrolled in this study. Total enrollment period for this trial is estimated to be 1 year. Follow-up duration is estimated to be 5 years. Overall duration of the trial is estimated to be 6 years. The trial begins with the enrollment of the first subject and ends after the last subject is exited from the trial after completing the last follow-up visit at approximately 5 years, all subjects are fully monitored, all outstanding data queries are resolved.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
155

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Deutsches Herzzentrum Berlin-Charité
        • Principal Investigator:
          • Volkmar Falk
        • Contact:
          • Destino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Patients who are clinically indicated for aortic valve replacement
  3. Patients who are willing and able to participate in the follow-up requirements, and provide written informed consent

Exclusion Criteria:

  1. Previous surgical or/and transcatheter cardiac valve replacement at any site
  2. Previous open-heart surgical valve repair at any site
  3. Any percutaneous cardiovascular intervention (excluding diagnostic percutaneous coronary artery intervention), cardiovascular surgery, carotid surgery within 30 days
  4. Untreated mitral, tricuspid, or pulmonary valve diseases requiring procedural intervention
  5. Untreated clinically significant coronary artery diseases requiring revascularization
  6. Acute myocardial infarct within the previous 30 days
  7. Severe right heart dysfunction
  8. Active infection requiring antibiotic therapy including infective endocarditis
  9. Hypertrophic obstructive cardiomyopathy (HOCM)
  10. Severe symptomatic carotid artery stenosis
  11. Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability
  12. Chronic kidney disease (eGFR<45 mL/min/1.73m2) or end-stage renal disease requiring chronic dialysis
  13. Hematologic disorders: Leukopenia (WBC < 3000 cell/mL), anemia (Hgb < 9 g/dL), thrombocytopenia (Plt< 50,000 cell/mL), or any known blood clotting disorder, deemed clinically significant after consultation with Hematooncology specialists
  14. Severe chronic lung disease
  15. Previous organ transplant or currently an organ transplant candidate Anatomical
  16. LVEF < 20%
  17. Left ventricular end diastolic diameter (LVEDD) >70mm
  18. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
  19. Native aortic valve geometry and size unfavorable for study bioprosthetic valve General
  20. Hemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance
  21. Urgent, emergency or salvage surgeries
  22. Known intolerance for periprocedural/post-procedural anticoagulation or antiplatelet therapy leading to be unable to undergo index procedure per physicians' judgement
  23. Life expectancy ≤ 1 year due to non-cardiac reasons
  24. Planned relevant concomitant procedure within 30 days post index procedure
  25. Current or recent participation (within 6 weeks prior to index procedure) in another drug or device trial
  26. Pregnant, breastfeeding or intend to become pregnant within 1 year
  27. Currently incarcerated or unable to give voluntary informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Venus-Neo group
Procedure: surgical aortic valve replacement
Device: Venus-Neo Surgical Aortic Valve
Implant of a Venus-Neo Surgical Aortic Valve

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
primary composite safety endpoint
Time Frame: 1 year
composite safety endpoint at 1 year, including: valve-related mortality, thromboembolism, aortic valve reintervention, structural valve deterioration, major paravalvular leak (defined as moderate or greater paravalvular leak or any paravalvular leak requiring intervention), valve thrombosis, endocarditis
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
secondary composite safety endpoint
Time Frame: 2 through 5 Years
safety is assessed over 1-year timeframe by comparing the occurrence of specific safety endpoints to the objective performance criteria (OPC) reported in Table I.1 in "ISO:5840-2:2021(E), Annex I, Methods of evaluating clinical data against objective performance criteria"
2 through 5 Years
Occurrence of each of the following adverse events
Time Frame: baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter
Occurrence of each of the following adverse events until 5 years, including: mortality, valve-related mortality, thromboembolism, aortic valve reintervention, structural valve deterioration, non-structural valve deterioration, all paravalvular leak, major paravalvular leak, valve thrombosis, endocarditis, all hemorrhage, major hemorrhage, bioprosthetic valve explant, hemolysis
baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinically acceptable bioprosthetic valve performance
Time Frame: baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter
Clinically acceptable bioprosthetic valve performance until 5 years: clinically acceptable effective orifice area (EOA), mean pressure gradient (MPG) <20mmHg, freedom from moderate or greater regurgitation (transvalvular and paravalvular), freedom from aortic valve reintervention, freedom from clinically significant bioprosthetic valve thrombosis
baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter
Procedure success
Time Frame: pre-discharge
Procedure success at pre-discharge: freedom from valve-related mortality, freedom from aortic valve reintervention, intended performance of bioprosthetic valve (mean gradient <20 mmHg, peak velocity <3 m/s, and less than moderate aortic regurgitation)
pre-discharge
New York Heart Association (NYHA) classification
Time Frame: baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter
New York Heart Association (NYHA) classification until 5 years
baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jilin Venus Haoyue Medtech Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Volkmar Falk, Deutsches Herzzentrum Berlin-Charité

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VSAF-23-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

to publish the results

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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