Status:

RECRUITING

A Prospective, Multicenter, Single-arm Study to Evaluate a Transcatheter Aortic Valve System Safety and Efficacy for the Treatment of Patients With Severe Aortic Stenosis

Lead Sponsor:

Pan Xiangbin

Conditions:

Severe Aortic Stenosis

Eligibility:

All Genders

70+ years

Phase:

NA

Brief Summary

Trial Title: Prospective, multicenter, single-arm target value clinical trial to evaluate the safety and efficacy of a transcatheter aortic valve system in the treatment of patients with severe aortic...

Eligibility Criteria

Inclusion Criteria:

  1. Age≥ 70 years;
  2. Patients with symptomatic severe aortic stenosis (mean pressure gradient across the aortic valve ≥ 40 mmHg (1 mmHg = 0.133 kPa) on echocardiography, or trans-aortic valve blood flow velocity ≥ 4.0 m/s, or aortic orifice area ≤ 1.0 cm2, or effective aortic orifice area index ≤0.6 cm2/m2)
  3. NYHA Grading ≥ Level II;
  4. Life expectancy of more than 1 year after implantation of the prosthetic valve;
  5. Assessed by not less than two cardiothoracic surgeons, documented as a contraindication to surgery, or documented as unsuitable for conventional surgery;
  6. Patients who can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and are willing to undergo relevant examinations and clinical follow-up.

Exclusion Criteria:

  1. The imaging data shows that it is anatomically unsuitable for transcatheter aortic valve implantation;
  2. Acute myocardial infarction (defined as Q-wave myocardial infarction, or non-Q-wave myocardial infarction with CK-MB≥ twice normal and/or elevated Tn (WHO definition)) occurring within 1 month before valve implantation);
  3. Received any therapeutic traumatic cardiac surgery (other than coronary revascularization) within 1 month before valve implantation;
  4. Implanted prosthetic heart valves at any location, or combined with other valves with severe stenosis or severe regurgitation;
  5. Hemorrhagic constitution or coagulation dysfunction (platelet PLT<50×10^9/L);
  6. Haemodynamic instability requiring continuous mechanical cardiac assistance;
  7. Severe left ventricular dysfunction, left ventricular ejection fraction LVEF <20%;
  8. Echocardiography shows intracardiac thrombosis or vegetation, etc.;
  9. Renal insufficiency decompensation (endogenous creatinine clearance rate<20ml/min);
  10. Active peptic ulcer or upper gastrointestinal bleeding within 3 months;
  11. Cerebrovascular events (CVAs) within 3 months before valve implantation, excluding transient ischemic attack;
  12. Allergy or contraindication to antiplatelet drugs, anticoagulant drugs, or contrast agents, resulting in the inability to perform preoperative or appropriate intraoperative medication, allergies, or contraindications to polymer materials;
  13. Patients with active infective endocarditis or other active infections;
  14. Concurrent participation in other drug or device studies.
  15. In the opinion of the investigator, it is not suitable for enrollment.

Key Trial Info

Start Date :

October 18 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 30 2029

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT06136429

Start Date

October 18 2023

End Date

December 30 2029

Last Update

November 18 2023

Active Locations (1)

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1

Beijing

Beijing, China