Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System

NCT05202977 | Enrolling By Invitation

• 1 other identifier: LP-TAVR-2021
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Transcatheter Aortic Valve Replacement

Keywords

aortic stenosis

Outcome Measures

Primary Outcomes (1)

• device success

  Immediate postoperative device success was defined as : successfully loading the valve into the delivery system, sending it to the target site through the delivery system, accurately releasing the artificial aortic valve and completely withdrawing the delivery system (valve orifice area \> 1.2cm2, mean aortic gradient\< 20mmhg or maximal aortic valve velocity \< 3 m/ s, and there is no moderate or severe valve stenosis)

  immediate post-surgical

Secondary Outcomes (13)

• Procedural success

  immediate post-surgical

• All-cause mortality

  immediate post-surgical, 7 days after procedure/prior to discharge, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years

• Myocardial infarction

  immediate post-surgical, 7 days after procedure/prior to discharge, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years

• Rate of disabling stroke

  7 days after procedure/prior to discharge, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years

• Rate of Severe bleeding(life-threatening or disabling)

  7 days after procedure/prior to discharge, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years

Study Arms (1)

SinocrownTM Transcatheter Aortic Valve Replacement System

EXPERIMENTAL

The experimental apparatus consisted of artificial aortic valve, transporter and grip-loading system.

Device: SinocrownTM Transcatheter Aortic Valve Replacement System

Interventions

SinocrownTM Transcatheter Aortic Valve Replacement System DEVICE

Subjects receiving SinocrownTM Transcatheter Aortic Valve Replacement System of Lepu Medical

SinocrownTM Transcatheter Aortic Valve Replacement System

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years ;
• 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）
• Patients with aortic annulus size≥17.5mm and ≤29mm (echocardiography measurement);
• The diameter of the ascending aorta of the patient was \< 45mm.
• Appear obvious symptoms caused by aortic stenosis, NYHA class Ⅱ to IV;
• 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.
• Subjects are willing to accept all clinical follow-up.
• 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%).

You may not qualify if:

• 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.
• Subjects with congenital unicuspid, without calcification.
• Any therapeutic or traumatic cardiac surgery within 30 days (within 3 months in case of drug-eluting stents implantation)
• The patient's heart has been implanted with other artificial heart valves, artificial rings, or severe mitral annulus calcification (MAC), severe (\> 3 +) mitral insufficiency.
• Hematological abnormalities, including leukopenia (WBC\<3×109/L), acute anemia (HB \<90g/L), thrombocytopenia (PLT\<50×109/L), bleeding constitution and coagulopathy ；
• Subjects with hemodynamic instability, requiring continuous mechanical heart assistance.
• Subjects who need emergency surgery for any reason;
• Hypertrophic cardiomyopathy with or without obstruction;
• Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) \<20%;
• The echocardiogram indicates the presence of a thrombus or vegetation;
• A history of active peptic ulcer or upper gastrointestinal bleeding within 3 months;
• Are allergic to nickel titanium alloys or contrast agents, and cannot tolerate anticoagulation and antiplatelet therapy;
• Cerebrovascular accident occurred within 6 months, including transient ischemic attack;
• renal insufficiency(creatinine\> 3.0mg/dL) and/or end-stage renal disease requiring Renal dialysis;
• Life expectancy\< 12 months;

Sponsors & Collaborators

• Lepu Medical Technology (Beijing) Co., Ltd.: lead

Study Sites (1)

Hefei High-tech Cardiovascular hospital

Hefei, Anhui, China

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Yongjian Wu

  Heifei High-tech Cardiovascular hospital

  STUDY CHAIR

• Weiyi Fang

  Heifei High-tech Cardiovascular hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2021
• First Posted: January 24, 2022
• Study Start: April 6, 2021
• Primary Completion: August 7, 2021
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 24, 2022

Record last verified: 2021-12

Locations

CN (1)