NCT04988243

Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: CCRF Inc., Beijing, China · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a prospective / retrospective, multicenterstudy after listing. The researchers preliminarily confirmed that they could be enrolled in this study according to the diagnosis of the subjects' medical history. After fully informed, they signed the informed consent, and met the TAVR inclusion requirements (see the inclusion criteria for details). At the same time, they registered the subjects in multiple centers. After the start of the trial, the participants were enrolled in the study, All the subjects who met the inclusion criteria but did not meet the discharge criteria were registered in the central registration system. The patients were followed up for 30 days, 6 months and 12 months, and followed up by telephone for 2, 3, 4 and 5 years.

Conditions

• Severe Aortic Valve Stenosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-08-01
• Primary completion: 2021-08-01
• Completion: 2028-08-01
• First posted: 2021-08-03
• Last updated: 2021-08-03