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Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System | Clinical Trials | Clareo Health

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Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System

A Prospective，Multicenter, Single-arm Clinical Trial to Evaluate Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System With Accessories in Patients With Symptomatic, Calcified and Severe Aortic Stenosis

NCT05202977•Lepu Medical Technology (Beijing) Co., Ltd.

View on ClinicalTrials.gov

Summary

This study was designed to preliminary verify the safety and of efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System With accessories in patients with symptomatic, calcified and severe aortic stenosis using objective performance criteria

Detailed Description

This prospective, single-center, single-arm clinical trial was designed to preliminary confirm the safety and efficacy of SinocrownTM transcatheter aortic valve system with accessories. According to the inclusion and exclusion criteria, 10 patients were enrolled and implanted with SinocrownTM .Patients will been followed up 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after valve implantation. The main follow-up included clinical symptoms and signs, cardiac ultrasound, etc. The primary endpoint was device success after TAVR, Secondary endpoints included procedural success, all-cause mortality, myocardial infarction, disabling stroke, severe bleeding, acute kidney injury, permanent pacemaker implantation, vascular complications, other complication, MACCEs, valvular function , cardiac function improvement, quality of life of patients.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 65 years ;
•2. Autologous degenerative aortic stenosis（evaluated by echocardiography: transaortic valve pressure gradient ≥40mmHg , or transaortic valve blood flow rate ≥4m/s, or aortic Valve area\<1.0cm2, or AVA \<0.5cm2 /m2）
•3. Patients with aortic annulus size≥17.5mm and ≤29mm (echocardiography measurement);
•4. The diameter of the ascending aorta of the patient was \< 45mm.
•5. Appear obvious symptoms caused by aortic stenosis, NYHA class Ⅱ to IV;
•6. Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
•7. Subjects are willing to accept all clinical follow-up.
•8. The cardiologist and cardiac surgeon evaluated the subject as unsuitable for surgical treatment (the risk of death or irreversible complications within 30 days after operation is expected to be above 50% , or contraindicated comorbidities such as prior chest radiotherapy, liver failure, diffuse severe calcification of the aorta, extreme weakness, etc.). Or Moderate or higher surgical risk (STS score ≥ 4%).

Exclusion Criteria

•1. defined as Q-wave myocardial infarction or non-Q-wave myocardial infarction with CK-MB level ≥ 2 times the upper limit of normal value and / or Tn increase.
•2. Subjects with congenital unicuspid, without calcification.
•3. Any therapeutic or traumatic cardiac surgery within 30 days (within 3 months in case of drug-eluting stents implantation)
•4. The patient's heart has been implanted with other artificial heart valves, artificial rings, or severe mitral annulus calcification (MAC), severe (\> 3 +) mitral insufficiency.
•5. Hematological abnormalities, including leukopenia (WBC\<3×109/L), acute anemia (HB \<90g/L), thrombocytopenia (PLT\<50×109/L), bleeding constitution and coagulopathy ；
•6. Subjects with hemodynamic instability, requiring continuous mechanical heart assistance.
•7. Subjects who need emergency surgery for any reason;
•8. Hypertrophic cardiomyopathy with or without obstruction;
•9. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) \<20%;
•10. The echocardiogram indicates the presence of a thrombus or vegetation;
+11 more criteria

Locations (1)

Hefei High-tech Cardiovascular hospital

Hefei, Anhui, China

Key Dates

Start Date

April 6, 2021

Primary Completion Date

August 7, 2021

Completion Date

August 1, 2026

Last Updated

January 24, 2022

Enrollment

ESTIMATED participants

Conditions

Transcatheter Aortic Valve Replacement

Interventions

SinocrownTM Transcatheter Aortic Valve Replacement System

DEVICE

Short Versus Long Antiplatelet Therapy After TAVI

NCT06518317

Transcatheter Aortic Valve Replacement

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RECRUITING

Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR

NCT04139616

Conduction DisturbancesTranscatheter Aortic Valve Replacement+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 24, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System

Inclusion Criteria

Exclusion Criteria

Short Versus Long Antiplatelet Therapy After TAVI

Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR

Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement

Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement

The Sentinel Registry

Intra-procedural ECG Changes During TAVR