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Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China

NCT04988243 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2021-08-03

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Hangzhou Qiming Medical Instrument Co., Ltd

    collaborator UNKNOWN

  • CCRF Inc., Beijing, China

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-31
Primary Completion
2021-08-31
Completion
2028-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04988243 on ClinicalTrials.gov