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

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: Recruiting
• Conditions: Severe Aortic Stenosis
• Intervention / Treatment: Device: RENATUS® TAVR

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lai Yongqiang; Phone Number: 010-64456376; Email: yongqianglai@outlook.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Anzhen Hospital, Capital Medical University
    • Contact: Lai Yongqiang; Phone Number: 010-64456376; Email: yongqianglai@outlook.com
  • Beijing, China
    • Recruiting
    • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
    • Contact: Xu Shangdong; Phone Number: 18611021519; Email: xushangdong@126.com
  • Beijing, China
    • Recruiting
    • Beijing Chaoyang Hospital, Capital Medical University
    • Contact: Li Bo; Phone Number: 13911365935; Email: libo1976@mail.ccmu.edu.cn
  • Beijing, China
    • Recruiting
    • Fu Wai Hospital, Chinese Academy of Medical Sciences
    • Contact: Zhao Jie; Phone Number: 13911036089; Email: fwzhaojie@126.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RENATUS® TAVR treatment	Device: RENATUS® TAVR; RENATUS® Transcatheter Aortic Valve System，an approved marketed TAVR

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Balance Medical Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2037

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID 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