TAVR for Aortic Valve Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNanjing First Hospital, Nanjing Medical University

About this trial

Transcatheter aortic valve replacement (TAVR) has became an important treatment of severe aortic stenosis (AS). Several randomized clinical trials showed that TAVR was non-inferior or superior to surgical aortic valve replacement (SAVR). However, many different issues have emerged: TAVR in younger patients? valve leaflet thrombosis? transcatheter valve durability? coronary reaccess after TAVR? TAVR in bicuspid aortic valve? TAVR in aortic regurgitation? etc. Hence, a prospective, multicenter database is created to provide the real-word data for these questions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of severe aortic stenosis or aortic regurgitation

Patients undergo transcatheter aortic valve replacement

Disqualifiers

None

Trial population

All patients undergoing transcatheter aortic valve replacement due to severe aortic valve stenosis or regurgitation were eligible into this registry.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • transcatheter heart valve

    Device

    patients with severe aortic valve disease underwent transcatheter heart valve

Treatment groups

5,000 Participants
are divided into 1 treatment group
Group A: TAVR in aortic valve disease1 intervention

Trial outcomes

Primary outcomes

1

all-cause death during follow-up

all-cause death during 5-year follow-up

Time frame
5 years

Secondary outcomes

1

cardiac death during follow-up

Cardiac death during 5-year follow-up

Time frame
5 years

Other outcomes

Sponsors and contacts

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