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NCT04988243

Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China

Sponsor: CCRF Inc., Beijing, China

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

320

Start Date

2021-08

Completion Date

2028-08

Last Updated

2021-08-03

Healthy Volunteers

Conditions

Severe Aortic Valve Stenosis

Interventions

OTHER

All aortic valve products on the market

1. Subjects with severe aortic valve stenosis 2. Subjects who plan (or have) to use the transcatheter aortic valve replacement system for percutaneous aortic valve replacement 3. The patients agreed to join the study, voluntarily signed the informed consent and completed the follow-up; 4. Be able to contact the subjects or their legal guardians / relatives; 5. The medical record records the subjects who have died and can't get any contact information of the subjects（ (for dead cases only) Sign the informed consent form, then check the inclusion and exclusion criteria, register after meeting the criteria, obtain the registration number, perform aortic valve replacement surgery, follow-up 24 hours, discharge, 30 days, 1 year, 2 years, 3 years, 4 years and 5 years after operation according to the test requirements, and carry out relevant follow-up according to the scheme requirements to collect data

Inclusion Criteria: 1. Severe aortic valve stenosis, defined as follows: 1. Symptomatic patients: * 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) 2. Asymptomatic patients: * 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; * Or aortic valve area ≤ 1.0cm ²（ Or AVA index ≤ 0.6 cm2 / m2), combined with aortic ejection peak ≥ 4.0 m / s or average differential pressure measured by echocardiography ≥ 40 mm Hg, combined with limited exercise tolerance test, abnormal blood pressure response or arrhythmia; * Or aortic valve area ≤ 1.0cm ²（ Or AVA index ≤ 0.6 cm2 / m2), combined with aortic ejection peak ≥ 4.0 m / s or average differential pressure measured by echocardiography ≥ 40 mm Hg, combined with LVEF \< 50% 2. Subjects who plan (or have) to use the transcatheter aortic valve replacement system for percutaneous aortic valve replacement 3. The patients agreed to join the study, voluntarily signed the informed consent and completed the follow-up; 4. Be able to contact the subjects or their legal guardians / relatives; 5. The medical record records the subjects who have died and can't get any contact information of the subjects（ (for dead cases only) Note: for dead subjects, they must meet 1, 2 and 5 at the same time before they can be included in the group. Exclusion Criteria: 1. Contraindications to any artificial biological valve implantation; 2. Any known allergies or contraindications; * Aspirin or heparin and bivalirudin; * Tigrelol and clopidogrel; * Nickel titanium alloy; * Contrast medium; 3. The patient is currently participating in drug or device research; 4. The patient is pregnant or lactating; 5. Aortic annulus diameter \< 17 mm or \> 32 mm; 6. The diameter of approach vessel was less than 5.0mm; 7. The investigator believes that the patient is not suitable to participate in this study or complete the follow-up specified in the protocol;