RECRUITINGPhase 4INTERVENTIONAL
Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population
THE TORCH TRIAL:Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population
About This Trial
The purpose of this study is to evaluate the safety and effectiveness of transcatheter aortic valve replacement in Chinese population.
Who May Be Eligible (Plain English)
Who May Qualify:
- Patients with symptomatic aortic stenosis/regurgitation
- Subject has been informed of the nature of the study, agrees to its provisions and has provided written willing to sign a consent form.
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
PROCEDURE
transcatheter aortic valve replacement
Locations (1)
The Second Affiliated Hospital, School of Medicine at Zhejiang University
Hanzhou, Zhejiang, China