Safety and Efficacy of the RENATUS® Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis

February 10, 2026 updated by: Beijing Balance Medical Technology Co., Ltd
This study is a prospective, non-randomized, observational, post-market follow-up trial designed to evaluate the safety and efficacy of the RENATUS® Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

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.
800

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

  • China
      • Beijing, China
        • Recruiting
        • Beijing Anzhen Hospital, Capital Medical University
        • Contact:
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
        • Contact:
      • Beijing, China
        • Recruiting
        • Beijing Chaoyang Hospital, Capital Medical University
        • Contact:
      • Beijing, China
        • Recruiting
        • Fu Wai Hospital, Chinese Academy of Medical Sciences
        • Contact:

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. Patients deemed eligible for TAVR by the treating physician, including those at high, intermediate, or low surgical risk, with a calculated Society of Thoracic Surgeons (STS) risk score;

  2. Symptomatic patients with severe aortic stenosis, defined by echocardiography as having at least one of the following:

    • Mean transvalvular pressure gradient ≥40 mmHg (1 mmHg = 0.133 kPa),
    • Peak aortic jet velocity ≥4.0 m/s,
    • Aortic valve area <1.0 cm², or Indexed effective orifice area <0.6 cm²/m²;
  3. Patients who understand the purpose of the trial, voluntarily agree to participate, provide written informed consent, and are willing to undergo required examinations and clinical follow-up.

Exclusion Criteria:

  1. Patients with a life expectancy of ≤1 year following prosthetic valve implantation;
  2. Patients who have experienced an acute myocardial infarction or undergone any therapeutic cardiac surgery within the past month;
  3. Patients with minimal or no calcification of the aortic annulus;
  4. Patients with aortic root anatomy or pathology deemed unsuitable for prosthetic valve implantation;
  5. Patients with multivalvular disease (severe stenosis and/or regurgitation);
  6. Patients with hematologic cachexia, including leukopenia (WBC <3×10⁹/L), acute anemia (Hb <90 g/L), thrombocytopenia (PLT <50×10⁹/L), bleeding diathesis, or coagulopathy;
  7. Patients with untreated coronary artery disease requiring revascularization;
  8. Patients with obstructive hypertrophic cardiomyopathy;
  9. Patients with severe left ventricular dysfunction (LVEF <20%);
  10. Patients with severe right ventricular dysfunction;
  11. Patients with intracardiac masses, fresh thrombi, or vegetations detected by echocardiography;
  12. Patients unable to tolerate anticoagulant or antiplatelet therapy;
  13. Patients who have experienced a cerebrovascular accident (CVA)-including ischemic or hemorrhagic stroke-within the past 3 months;
  14. Patients with decompensated renal insufficiency;
  15. Patients with active infective endocarditis or other active infections;
  16. Patients with untreated conduction system disease requiring pacemaker implantation;
  17. Patients who have participated in another drug or medical device clinical trial and have not yet reached the primary endpoint assessment timepoint;
  18. Any other condition, as determined by the investigator, that renders the patient unsuitable for transcatheter aortic valve intervention.

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: RENATUS® TAVR treatment
Device: RENATUS® TAVR
RENATUS® Transcatheter Aortic Valve System，an approved marketed TAVR

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
Time Frame
Cumulative all-cause mortality (all-cause mortality includes both cardiac and non-cardiac deaths)
Time Frame: 1 year post-procedure
1 year post-procedure

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
Time Frame
Procedural success rate
Time Frame: Perioperative
Perioperative
Device success rate;
Time Frame: Perioperative
Perioperative
All-cause mortality at 1, 3, 5, and 10 years
Time Frame: 1, 3, 5, and 10 years
1, 3, 5, and 10 years

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
Time Frame
Transvalvular pressure gradient at 30 days and 1 year post-procedure;
Time Frame: 30 days and 1 year post-procedure;
30 days and 1 year post-procedure;
Valve performance changes: valvular regurgitation, paravalvular leak, etc.;
Time Frame: 1 year post-procedure
1 year post-procedure
Incidence of major adverse cardiovascular and cerebrovascular events (MACCE): death, disabling stroke, myocardial infarction, arrhythmia, conduction block, pacemaker implantation, etc.
Time Frame: 1, 3, 5, and 10 years
1, 3, 5, and 10 years
Incidence of valve-related complications: infective endocarditis, hemolysis, valve stenosis, prosthetic valve failure, and other manifestations of valve dysfunction
Time Frame: 1, 3, 5, and 10 years
1, 3, 5, and 10 years
Reoperation rate;
Time Frame: 1, 3, 5, and 10 years
1, 3, 5, and 10 years
NYHA functional classification;
Time Frame: 1 year post-procedure
1 year post-procedure
Patient-reported quality of life score.
Time Frame: 1 year post-procedure
1 year post-procedure
Hospital readmission rate;
Time Frame: 1, 3, 5, and 10 years
1, 3, 5, and 10 years
Anticoagulation-related complications.
Time Frame: 1, 3, 5, and 10 years
1, 3, 5, and 10 years

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.
Beijing Balance Medical Technology Co., Ltd

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.
February 1, 2026

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.
September 1, 2027

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.
September 1, 2037

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).
February 3, 2026

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.
February 10, 2026

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.
February 17, 2026

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.
February 17, 2026

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.
February 10, 2026

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.
February 1, 2026

More Information

Terms related to this study

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.
  • KS2026002
  • Z251100004625015 (Other Grant/Funding Number: Beijing Science and Technology Commission)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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