Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Jun 13, 2016

Keywords

ClinConnect Summary

This clinical trial is looking at a procedure called transcatheter aortic valve replacement (TAVR) in Chinese patients who have symptomatic aortic stenosis, a condition where the heart's aortic valve becomes narrowed and causes problems with blood flow. The goal of the study is to see how safe and effective this treatment is for these patients.

To be eligible for the trial, participants need to have symptoms related to aortic stenosis and must be technically suitable for the procedure. They should also be willing to follow the study guidelines and attend follow-up appointments. However, patients who have certain allergies to medications used during the procedure, refuse blood transfusions, or have a life expectancy of less than a year may not qualify. If selected, participants can expect to receive the TAVR procedure and will be monitored closely afterward to assess their recovery and overall health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with symptomatic aortic stenosis/regurgitation
• • Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
• • The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.
• • Patients are technical and anatomical eligible for interventions
• Exclusion Criteria:
• • A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: Aspirin Heparin (HIT/HITTS) and bivalirudin Nitinol (titanium or nickel) Ticlopidine and clopidogrel Contrast media
• • Subject refuses a blood transfusion.
• • Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
• • Life expectancy is less than one year