Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCCRF Inc., Beijing, China

About this trial

The purpose of this study was to observe the safety and effectiveness of transcatheter aortic valve replacement in patients with aortic valve stenosis in a real-world clinical practice environment.

Eligibility criteria

Qualifiers

The mean differential pressure measured by echocardiography ≥ 40mm Hg

Or peak aortic ejection ≥ 4.0 m / S

Or aortic valve area ≤ 1.0cm ²( Or AVA index ≤ 0.6 cm2 / m2)

Severe aortic stenosis and aortic valve area ≤ 1.0cm ²( 6 cm2 / m2) with aortic ejection peak value ≥ 5.0 M / s or mean pressure difference measured by --echocardiography ≥ 60 mm Hg;

Disqualifiers

Contraindications to any artificial biological valve implantation;

Any known allergies or contraindications;

Aspirin or heparin and bivalirudin;

Tigrelol and clopidogrel;

Trial design

Treatments tested in this trial

  • All aortic valve products on the market

Treatment groups

320 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

CCRF Inc., Beijing, China

Lead sponsor

Hangzhou Qiming Medical Instrument Co., Ltd

Collaborator