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Transcatheter Aortic Valve ReplacementNCT05202977

Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System

A study testing SinocrownTM Transcatheter Aortic Valve Replacement System in people with Transcatheter Aortic Valve Replacement, run by Lepu Medical Technology (Beijing) Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Transcatheter Aortic Valve Replacement
What is being tested?
SinocrownTM Transcatheter Aortic Valve Replacement System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
6 Apr 2021to Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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%).

Who cannot join

  • 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.
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  • 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;
  • Significant aortic diseases, including abdominal aortic or thoracic aortic aneurysm(defined as maximum lumen diameter > 50mm, obvious distortion), atherosclerosis of the aortic arch(especially bulge with thickness > 5mm or ulceration), narrowing of the abdominal or thoracic aorta(especially calcification and irregular surface), and severe curvature of the thoracic aorta;
  • The iliac-femoral artery cannot be inserted with a guide sheath of 22F or above, such as severely obstructed with calcification, severely tortuous or vessel diameter less than 6mm;
  • Screening participant who is participating in other drug or medical device clinical trials;
  • Active infective endocarditis or other active infections;
  • Anatomically, the approach or aortic root is not suitable for TAVR (such as a high risk of coronary artery occlusion).
  • Other conditions considered by the investigator to be inappropriate for participation in this clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hefei High-tech Cardiovascular hospital

    Hefei, Anhui

Other trials in China

About this study

Official title: 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

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

Read the 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.

Being tested
SinocrownTM Transcatheter Aortic Valve Replacement System
Keywords
aortic stenosis
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.

  • SinocrownTM Transcatheter Aortic Valve Replacement SystemDevice

    Subjects receiving SinocrownTM Transcatheter Aortic Valve Replacement System of Lepu Medical

Study groups in NCT05202977
Study groupRoleWhat they receive
SinocrownTM Transcatheter Aortic Valve Replacement SystemExperimentalThe experimental apparatus consisted of artificial aortic valve, transporter and grip-loading system.
Receives: Device: SinocrownTM Transcatheter Aortic Valve Replacement System

What is being measured

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

  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)

    Measured: immediate post-surgical

Secondary outcomes (13)

  1. Procedural success

    Device success without death and aortic valve reintervention during operation

    Measured: immediate post-surgical

  2. All-cause mortality

    including cardiac, non-cardiac and unexplained deaths

    Measured: 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

  3. Myocardial infarction

    Rate of patients with myocardial infarction

    Measured: 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

  4. Rate of disabling stroke

    Disabling stroke was defined as mRS ≥ 2, and the mRS score increased by more than 1 point compared with the last visit

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

  5. Rate of Severe bleeding(life-threatening or disabling)

    Severe degree was defined as type 3a or above（according to BARC）

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

  6. acute kidney injury

    Rate of patients with acute kidney injury

    Measured: 7 days after procedure/prior to discharge, 30 days after procedure

  7. permanent pacemaker implantation

    Rate of patients implanted with permanent pacemaker

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

  8. vascular complications

    Vascular complications mainly include dissection, occlusion, rupture and bleeding of access vessels.

    Measured: immediate post-surgical, 7 days after procedure/prior to discharge

  9. other operative complication

    including conversion to surgery, unexpected cardiopulmonary mechanical assistance, coronary artery occlusion, ventricular septal perforation, mitral valve injury or loss of function, pericardial tamponade, endocarditis, valve thrombosis, valve ectopic (displacement, embolization, misrelease), and so on.

    Measured: immediate post-surgical, 7 days after procedure/prior to discharge

  10. The incidence of major adverse cardiovascular and cerebrovascular events during the trial(MACCEs)

    Incidence of MACCEs (including mortality, stroke, myocardial infarction, reoperation, arrhythmias and conduction blocks) during the trial.

    Measured: 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

  11. Valve and heart function

    Doppler echocardiography was used to evaluate the valve performance at each follow-up point, including valve orifice area, mean aortic gradient, degree of valve regurgitation, left ventricular ejection fraction LVEF, end diastolic left ventricular inner diameter LVEDd, moderate or above perivalvular leakage PVL, and degree of aortic stenosis.

    Measured: immediate post-surgical, 7 days after procedure/prior to discharge, 30 days, 6 months, 12 months

  12. Cardiac function improvement

    Cardiac function improvement is accessed by NYHA cardiac function classification increases from baseline to discharge, 30 days, 6 months, 12 months

    Measured: 7 days after procedure/prior to discharge, 30 days, 6 months, 12 months

  13. Quality of life of patients

    Quality of Life of patients accessed by EuroQol-5 Dimensions (EQ-5D) Questionnaire. The higher scores mean a better health state. Recording changes from baseline to 30 days, 6 months, 12 months

    Measured: 30 days, 6 months, 12 months

Timeline

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

  1. First posted24 Jan 2022
  2. Study start6 Apr 2021
  3. Primary completion7 Aug 2021
  4. Study completionAug 2026 (estimated)

Resources

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
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05202977
Sponsor's protocol ID
LP-TAVR-2021
Status last verified
Dec 2021
First submitted
31 Dec 2021
Last updated
24 Jan 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing SinocrownTM Transcatheter Aortic Valve Replacement System in people with Transcatheter Aortic Valve Replacement, run by Lepu Medical Technology (Beijing) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

device success (time frame: immediate post-surgical). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05202977.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.

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