Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

The purpose of this study is to evaluate the safety and effectiveness of transcatheter aortic valve replacement in Chinese population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • transcatheter aortic valve replacement

    Procedure/Surgery

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: Aortic Stenosis/regurgitationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Death from any cause

Time frame
1 year

Secondary outcomes

1

stroke

Time frame
30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years
2

death from cardiac causes

Time frame
30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years
3

myocardial infarction

Time frame
30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years
4

repeated hospitalization

Time frame
30days, 6months,1 year,2 years, 3 years, 4 years, 5 years, 10 years

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

The Second Affiliated Hospital, School of Medicine at Zhejiang UniversityRecruiting310000, Hanzhou, ZhejiangChinaChina

Sponsors and contacts

Click on the lead sponsor to view all of their trials.