Severe Aortic Valve StenosisNCT04988243

Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China

A study testing All aortic valve products on the market in people with Severe Aortic Valve Stenosis, run by CCRF Inc., Beijing, China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Severe Aortic Valve Stenosis
What is being tested?: All aortic valve products on the market
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 320 participants
Where: No sites listed yet
Study dates: Aug 2021to Aug 2028
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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:

Show all 14Show fewer

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.

Who cannot join

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;

Show all 11Show fewer

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;

About this study

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.

Read the 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
Being tested: All aortic valve products on the market
Medical subject headings: Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

All aortic valve products on the marketOther
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

Study groups in NCT04988243
Study group	Role	What they receive
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 Receives: Other: All aortic valve products on the market

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2021Aug 2028

First posted3 Aug 2021
Study startAug 2021 (estimated)
Primary completionAug 2021 (estimated)
Study completionAug 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Severe Aortic Valve StenosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Model description: 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
Masking: None (open label)
Enrolment: 320 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04988243
Sponsor's protocol ID: DB001
Status last verified: Aug 2021
First submitted: 23 Jul 2021
Last updated: 3 Aug 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

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.
PubMed 41151411

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
Severe Aortic Valve Stenosis, Valvular Heart Disease
RecruitingObservational study
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
Recruiting
A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI)
Aortic Stenosis, Severe, Aortic Valve Stenosis
Recruiting
ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
Aortic Stenosis, Severe
Not yet recruiting
Sparrow App Guided Evaluation (SAGE) Vanguard Trial for Aortic Stenosis in Adults Aged Seventy and Older
Moderate or Severe Aortic Stenosis

All Severe Aortic Valve Stenosis trials