Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China

NCT ID: NCT04988243

Last Updated: 2021-08-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-31
• Study Completion Date: 2028-08-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prospective and retrospective study of subjects undergoing aortic valve surgery

This study is a prospective / retrospective, multicenter, and observational study after listing. The researchers can initially determine that they can be enrolled in the study according to the history diagnosis of the subjects. After fully informed, they sign informed consent form. After the evaluation of the researchers, they meet the TAVR selection requirements, and register the subjects in multiple centers at the same time

Group Type: OTHER

All aortic valve products on the market

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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;

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Qiming Medical Instrument Co., Ltd

UNKNOWN

Sponsor Role: collaborator

CCRF Inc., Beijing, China

INDUSTRY

Sponsor Role: lead

Responsible Party

Yaling Han, M.d., Ph.D.

Academlcan/chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

DB001

Identifier Type: -

Identifier Source: org_study_id