Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China

NCT04988243 | Not Yet Recruiting

• 1 other identifier: DB001
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Severe Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Primary end point: the incidence of all-cause death 12 months after operation

  After subjects completed aortic valve replacement surgery, whether prospectively or retrospectively, all-cause mortality at 12 months after operation was collected according to the time node of subjects' enrollment

  12 months after aortic valve replacement

Secondary Outcomes (8)

• The compound incidence of death, surgery, severe stroke, life-threatening bleeding, serious vascular complications and acute renal failure (within 30 days after operation);

  Within 30 days after aortic valve replacement

• The implantation rate of permanent pacemaker within 30 days;

  Within 30 days after aortic valve replacement

• All stroke (disabled or not disabled) within 12 months and 2, 3, 4 and 5 years

  12 months and within 2, 3, 4 and 5 years

• the incidence of life-threatening bleeding within 12 months and 2, 3, 4 and 5 years;

  12 months and within 2, 3, 4 and 5 years

• The incidence of reoperation due to dysfunction of prosthetic valve within 12 months and 2,3,4,5 years;

  12 months and within 2, 3, 4 and 5 years

Study Arms (1)

Prospective and retrospective study of subjects undergoing aortic valve surgery

OTHER

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

Other: All aortic valve products on the market

Interventions

All aortic valve products on the market 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

Prospective and retrospective study of subjects undergoing aortic valve surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe aortic valve stenosis, defined as follows:
• 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)
• 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%
• Subjects who plan (or have) to use the transcatheter aortic valve replacement system for percutaneous aortic valve replacement
• The patients agreed to join the study, voluntarily signed the informed consent and completed the follow-up;
• Be able to contact the subjects or their legal guardians / relatives;
• 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.

You may not qualify if:

• Contraindications to any artificial biological valve implantation;
• Any known allergies or contraindications;
• Aspirin or heparin and bivalirudin;
• Tigrelol and clopidogrel;
• Nickel titanium alloy;
• Contrast medium;
• The patient is currently participating in drug or device research;
• The patient is pregnant or lactating;
• Aortic annulus diameter \< 17 mm or \> 32 mm;
• The diameter of approach vessel was less than 5.0mm;
• The investigator believes that the patient is not suitable to participate in this study or complete the follow-up specified in the protocol;

Sponsors & Collaborators

• CCRF Inc., Beijing, China: lead
• Hangzhou Qiming Medical Instrument Co., Ltd: collaborator

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academlcan/chief physician

Model Details: Retrospective subjects were subjects who had completed transcatheter aortic valve replacement at the beginning of the study. Previous data such as demography and treatment of subjects before the start of the study will be realized by reviewing medical records. Follow up data not traceable to medical records and follow-up data after the start of the study, Prospective subjects were those who were undergoing or planned to undergo transcatheter aortic valve replacement at the beginning of the study. Subjects were enrolled from the beginning of the first case to one year later. The demographic, treatment and follow-up data of subjects will be collected through clinical follow-up or telephone follow-up

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 3, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2021
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 3, 2021

Record last verified: 2021-08