Severe Aortic StenosisNCT07414342
Safety and Efficacy of the RENATUS® Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis
A study testing RENATUS® TAVR in people with Severe Aortic Stenosis, run by Beijing Balance Medical Technology Co., Ltd at 4 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Severe Aortic Stenosis
- What is being tested?
- RENATUS® TAVR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 4 sitesChina
- Study dates
- Feb 2026to Sep 2037
- Phase
- Interventional
- 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 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 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;
- 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.
Who cannot join
- Patients with a life expectancy of ≤1 year following prosthetic valve implantation;
- Patients who have experienced an acute myocardial infarction or undergone any therapeutic cardiac surgery within the past month;
- Patients with minimal or no calcification of the aortic annulus;
- Patients with aortic root anatomy or pathology deemed unsuitable for prosthetic valve implantation;
- Patients with multivalvular disease (severe stenosis and/or regurgitation);
- 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;
Show all 18Show fewer
- Patients with untreated coronary artery disease requiring revascularization;
- Patients with obstructive hypertrophic cardiomyopathy;
- Patients with severe left ventricular dysfunction (LVEF <20%);
- Patients with severe right ventricular dysfunction;
- Patients with intracardiac masses, fresh thrombi, or vegetations detected by echocardiography;
- Patients unable to tolerate anticoagulant or antiplatelet therapy;
- Patients who have experienced a cerebrovascular accident (CVA)-including ischemic or hemorrhagic stroke-within the past 3 months;
- Patients with decompensated renal insufficiency;
- Patients with active infective endocarditis or other active infections;
- Patients with untreated conduction system disease requiring pacemaker implantation;
- Patients who have participated in another drug or medical device clinical trial and have not yet reached the primary endpoint assessment timepoint;
- Any other condition, as determined by the investigator, that renders the patient unsuitable for transcatheter aortic valve intervention.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing
Lai Yongqiang, 010-64456376, yongqianglai@outlook.com
- Recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing
Li Bo, 13911365935, libo1976@mail.ccmu.edu.cn
- Recruiting
Fu Wai Hospital, Chinese Academy of Medical Sciences
Beijing
Zhao Jie, 13911036089, fwzhaojie@126.com
- Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing
Xu Shangdong, 18611021519, xushangdong@126.com
About this study
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.
- Conditions
- Severe Aortic Stenosis
- Being tested
- RENATUS® TAVR
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RENATUS® TAVRDevice
RENATUS® Transcatheter Aortic Valve System，an approved marketed TAVR
| Study group | Role | What they receive |
|---|---|---|
| RENATUS® TAVR treatment | Experimental | Not described Receives: Device: RENATUS® TAVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative all-cause mortality (all-cause mortality includes both cardiac and non-cardiac deaths)
Measured: 1 year post-procedure
Secondary outcomes (3)
Procedural success rate
Measured: Perioperative
Device success rate;
Measured: Perioperative
All-cause mortality at 1, 3, 5, and 10 years
Measured: 1, 3, 5, and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Aortic StenosisStudies 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Balance Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414342
- Sponsor's protocol ID
- KS2026002
- Other IDs
- Z251100004625015
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the RENATUS® Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT07414342
- Acronym / sponsor ID
- KS2026002
- Conditions
- Severe Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Beijing Balance Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2037 (estimated)
- First posted
- 17 Feb 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RENATUS® TAVR treatment | Experimental | Device: RENATUS® TAVR |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
- Symptomatic patients with severe aortic stenosis, defined by echocardiography as having at least one of the following:
- 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.
Key exclusion criteria (18 listed)
- Patients with a life expectancy of ≤1 year following prosthetic valve implantation;
- Patients who have experienced an acute myocardial infarction or undergone any therapeutic cardiac surgery within the past month;
- Patients with minimal or no calcification of the aortic annulus;
- Patients with aortic root anatomy or pathology deemed unsuitable for prosthetic valve implantation;
- Patients with multivalvular disease (severe stenosis and/or regurgitation);
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 |
|---|---|---|
| RENATUS® TAVRRENATUS® Transcatheter Aortic Valve System，an approved marketed TAVR | Device | RENATUS® TAVR treatment |
Primary outcome
Cumulative all-cause mortality (all-cause mortality includes both cardiac and non-cardiac deaths)
Time frame: 1 year post-procedure
3 secondary outcomes
Procedural success rate
Time frame: Perioperative
Device success rate;
Time frame: Perioperative
All-cause mortality at 1, 3, 5, and 10 years
Time frame: 1, 3, 5, and 10 years
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 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Severe Aortic Stenosis
Active, not recruiting
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
Aortic Valve Stenosis, Regurgitation, Aortic
Not yet recruiting
Effect of Double-Tap Optimization on Valve Expansion and Hemodynamics in Balloon-expandable Transcatheter Aortic Valve Implantation: A Randomized Clinical Trial (DO-OPT TAVI Trial)
Severe Aortic Stenosis
Active, not recruiting
Target Value Study to Evaluate the Safety and Efficacy of the Taurus NXT® Transcatheter Aortic Valve System for the Treatment of Severe Calcific Aortic Stenosis
Aortic Stenosis
RecruitingObservational study
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
Severe Aortic Valve Stenosis, Valvular Heart Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RENATUS® TAVR in people with Severe Aortic Stenosis, run by Beijing Balance Medical Technology Co., Ltd at 4 sites in China.
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 6 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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?
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?
Contact Lai Yongqiang (010-64456376, yongqianglai@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative all-cause mortality (all-cause mortality includes both cardiac and non-cardiac deaths) (time frame: 1 year 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 17 Feb 2026.