Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China

Overview

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.

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

Primary outcome measures

• Primary end point: the incidence of all-cause death 12 months after operation [Time frame: 12 months after aortic valve replacement]

Secondary outcome measures (8)

• The compound incidence of death, surgery, severe stroke, life-threatening bleeding, serious vascular complications and acute renal failure (within 30 days after operation); [Time frame: Within 30 days after aortic valve replacement]
• The implantation rate of permanent pacemaker within 30 days; [Time frame: Within 30 days after aortic valve replacement]
• All stroke (disabled or not disabled) within 12 months and 2, 3, 4 and 5 years [Time frame: 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; [Time frame: 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; [Time frame: 12 months and within 2, 3, 4 and 5 years]
• The incidence of readmission due to symptoms and signs of aortic valve disease within 12 months and 2,3,4,5 years; [Time frame: 12 months and within 2, 3, 4 and 5 years]
• The incidence of prosthetic valve dysfunction at 12 months (moderate or severe stenosis or reflux by ultrasonography); [Time frame: 12 months and within 2, 3, 4 and 5 years]
• The incidence of thrombus in clinical and subclinical prosthetic heart valves at 12 months; [Time frame: 12 months after aortic valve replacement]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Fang Y, Wang H, Li Y, Zhao X, Wang B, Wang G, Liu D, Yan C, Xu K, Han Y. Identification of key diagnostic and prognostic biomarkers for aortic valve stenosis with coronary artery disease through immunological profiling integrating proteomics, single-cell sequencing, and machine learning. Biochem Biophys Res Commun. 2025 Nov 14;789:152855. doi: 10.1016/j.bbrc.2025.152855. Epub 2025 Oct 24. PMID 41151411

Identifiers

NCT: NCT04988243 · DB001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗