NCT07414342

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
135mo left

Started Feb 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Feb 2026Sep 2037

Study Start

First participant enrolled

February 1, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2037

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

1.6 years

First QC Date

February 3, 2026

Last Update Submit

February 10, 2026

Conditions

Severe Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

  • Cumulative all-cause mortality (all-cause mortality includes both cardiac and non-cardiac deaths)

    1 year post-procedure

Secondary Outcomes (3)

  • 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 Outcomes (9)

  • 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

  • +6 more other outcomes

Study Arms (1)

RENATUS® TAVR treatment

EXPERIMENTAL
Device: RENATUS® TAVR

Interventions

RENATUS® TAVRDEVICE

RENATUS® Transcatheter Aortic Valve System，an approved marketed TAVR

RENATUS® TAVR treatment

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

RECRUITING

Beijing Chaoyang Hospital, Capital Medical University

Beijing, China

RECRUITING

Fu Wai Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Central Study Contacts

Lai Yongqiang

CONTACT

010-64456376yongqianglai@outlook.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 17, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2037

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations

CN(4)