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Tests treatment safety and results for Severe Aortic Stenosis
Official title Safety and Efficacy of the RENATUS® Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis
ClinicalTrials.gov ID: NCT07414342
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 100
You may be able to join if
- Patients deemed eligible for TAVR by the treating physician, including those at high, intermediate, or low surgical risk, with a calculated Society...
- 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;
You likely can't join 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...
See the full eligibility criteria
- 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.
- 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;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.