RENATUS transcatheter aortic valve for severe aortic stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, non-randomized, observational post-market follow-up that will monitor the safety and effectiveness of the RENATUS transcatheter aortic valve system in patients with symptomatic severe aortic stenosis. Participants judged eligible for transcatheter aortic valve replacement by their treating physician will receive the RENATUS device and undergo scheduled clinical and echocardiographic follow-up. The study will collect procedural outcomes, valve performance measures such as mean gradient and valve area, and adverse event data over time. Findings will inform longer-term device safety and performance in a real-world population.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Study coordinator: Lai Yongqiang
• Email: yongqianglai@outlook.com
• Phone: 010-64456376

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Registry of Transcatheter Aortic Valve Treatments at a Italian Center

  This registry tests how safe and effective transcatheter valve procedures are in adults with severe aortic stenosis treated at a single Italian center.

  Recruiting Fondazione IRCCS Policlinico San Matteo di Pavia · Pavia, Pavia · NCT07596394

• CT-FFR-guided revascularization for people with severe aortic stenosis

  This study will see if adding CT-FFR (a noninvasive blood-flow test) to preoperative CT angiography helps doctors decide whether people with severe aortic stenosis need coronary revascularization before valve replacement.

  Recruiting Yan'an Affiliated Hospital of Kunming Medical University · Kunming, Yunnan · NCT07469371

• Pre-emptive LAVA-ECMO support for complex, high-risk TAVR

  The team will try pre-emptive left atrial veno-arterial ECMO to stabilize adults with severe aortic stenosis undergoing complex, high-risk TAVR who are unstable or at risk of instability.

  Recruiting at 2 sites Atlantic Health System · Detroit, Michigan and 1 other locations · NCT07309029

• Comparing the DurAVR transcatheter heart valve with SAPIEN and Evolut valves for severe aortic stenosis

  This trial will test whether the DurAVR transcatheter heart valve works as well and is as safe as SAPIEN or Evolut valves in people with severe calcific aortic stenosis, and it also includes a registry for people needing valve‑in‑valve procedures.

  Recruiting Anteris Technologies Ltd. · Copenhagen, Capital Region of Denmark · NCT07194265

• Navitor TAVI valve in Japanese patients with severe aortic stenosis

  This study will try the Navitor transcatheter aortic valve with the FlexNav delivery system in about 100 Japanese adults with symptomatic severe aortic stenosis to track safety and how well the valve works.

  Recruiting at 3 sites Abbott Medical Devices · Fukuoka and 2 other locations · NCT07193888

• Improving quality of life for patients with severe aortic stenosis

  This study looks at how severe aortic stenosis affects the daily lives of patients to see if a new heart valve procedure can help improve their quality of life.

  Recruiting Hospices Civils de Lyon · Clermont-Ferrand and 3 other locations · NCT06477042

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.