Clinical Trial in China for Aortic Valve Stenosis

Department
Recruiting
65 years or above
All
Phase N/A
53 participants needed
15 Locations

Brief description of study

The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis disease who are at high or prohibitive surgical risk.

Detailed description of study

This study is a prospective, multicenter, single-arm, clinical study.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Diseases of Aortic Valve, Aortic Stenosis Disease
  • Age: 65 years or above
  • Gender: All

Inclusion Criteria:
  1. Age ≥ 65;
  2. Patients with symptomatic aortic valve regurgitation diseases, and New York HeartAssociation (NYHA) ≥ II;
  3. Subject must have Society of Thoracic Surgeons (STS) score ≥8% or have been evaluatedinoperable by the surgical team [defined as rate of death #50% within 30 dpost-surgery or accompanied with irreversible occasions of other factors preventurgeries (such as heavily calcified (porcelain) ascending aorta, weakness, chesttion, liver dysfunction, pulmonary dysfunction and so on ); (Note: age ofinoperable patients can be expanded to ≥ 50);
  4. Aortic valve anatomy is suitable for TAVR evaluated by the investigators;
  5. Patients who can sign informed consent form, and are willing to accept relevantxaminations and clinical follow-ups.
Exclusion Criteria:
  1. Active endocarditis;
  2. Acute myocardial infarction or coronary revascularization occurred within 1 monthbefore procedure;
  3. Cerebrovascular accident (CVA) occurred within 30 days before procedure;
  4. The echocardiogram indicates the presence of mass, thrombus or vegetation in leftventricle and left atrium;
  5. Hypertrophic obstructive cardiomyopathy;
  6. Other valve diseases that need interventions;
  7. Previous aortic valve implantation (mechanical or biological);
  8. Allergic to Nickel-titanium alloys or contrast agents or cattle-originated products;
  9. Known allergy or contraindication to all anticoagulation, or anticoagulation can notbe used during the TAVR;
  10. In presence one of the following (from selection to the day of procedure index): ather diseases that may shorten life expectancy to less than 12 months (recurrent ortastatic cancer, congestive heart failure); b drug abuse (such as cocaine, heroinnd so on); c planned additional operations that may result in incompliance or dataconfusion;
  11. Stenosis of common carotid artery, internal carotid artery or vertebral artery #70%;
  12. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%;
  13. Hepatic encephalopathy or acute active hepatitis;
  14. Receiving hemodialysis;
  15. Bleeding tendency or history of coagulopathy or refuse to receive transfusion;
  16. Active gastrointestinal (GI) ulcer or bleeding;
  17. Severe dementia;
  18. Patients who need emergency surgery for any reason;
  19. Patients are participating in other drugs or medical devices clinical trial;
  20. Pregnant or plan to be pregnant, or are taking estrogen or estrogen-like drugs (Womenuspected of pregnancy must have a negative serum or urine test for human villousgonadotropin prior to enrollment in the study);
  21. Other inappropriate occasions according to the investigators.

Updated on 03 Dec 2024. Study ID: S202112-01

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