To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Insufficiency

NCT05424653 | Unknown

• 1 other identifier: Silara202101
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Symptomatic Aortic Insufficiency

Conditions

Aortic Insufficiency

Outcome Measures

Primary Outcomes (5)

• Rate of Device success

  Device Success is defined as a composite of : Absence of procedural mortality AND Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system AND Correct positioning of prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve (mean aortic valve gradient\<20 mmHg or peak velocity\<3 m/s, and no moderate or more prosthetic valve regurgitation

  Immediate post- procedure

• Rate of Procedure success

  Procedure Success is defined as no death, stroke, myocardial infarction and renal failure occurred within 72 hours after the operation on the basis of the final device success.

  Immediate post procedure

• Rate of none or trace AR

  30 days

• Rate of All cause mortality,including Cardiac death, non-cardiac death and unexplained death

  Percentage of subjects who died from all causes in this population

  30 days

• Incidence of MACCE

  MACCE includs death, stroke, MI, re-procedure, conduction disturbances and cardiac arrhythmias

  30 days

Secondary Outcomes (17)

• Delivery system performance

  Immediate post-procedure

• Retrieval system performance (if need)

  Immediate post-procedure

• Exchange system evaluation

  Immediate post-procedure

• Valvular function evaluation, including valve stenosis, AR, valve function(e.g. EOA, gradient) and PVL

  Immediate post-procedure, 7 days or discharge, 30 days, 6 months and 12months

• Quality of Life Assessment

  30 days, 6 months,and 12 months

Study Arms (1)

Severe Symptomatic Aortic Regurgitation

EXPERIMENTAL

Patients will be treated with transcatheter aortic valve system

Device: Transcatheter Aortic Valve System

Interventions

Transcatheter Aortic Valve System DEVICE

Procedure: Transcatheter Aortic Valve Replacement

Severe Symptomatic Aortic Regurgitation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 60 years old;
• Subjects with symptomatic severe aortic valve regurgitation.
• NYHA Functional Class ≥II.
• Life expectancy after aortic valve implantation thought to be \>1 year，
• Native valvular or peripheral vascular anatomy is appropriate for TAVR.
• Patient is assessed by at least two cardiothoracic surgeons and recorded as not suitable for surgery (defined as a risk of operative mortality after 30 days\>50%，or severe irreversible comorbidities or other factors affecting surgery (e.g., porcelain aorta, frailty, chest malformation, severe liver disease, severe lung disease, etc.)), or patients at high risk of surgery（Euroscore≥20%, or STS≥8）,or patient not agree open surgery.
• Patient can understand the purpose of the study, voluntarily participates and signs the informed consent form and is willing to accept the relevant examination and clinical follow-up visits.

You may not qualify if:

• Anatomy is not appropriate for percutaneous valve implantation. Native valve annulus diameter is not in the scope of application(native TAV diameter ≤20mm,or ≥28mm
• Evidence of an acute myocardial infarction within 30 days prior to the study procedure, defined as: Q-wave myocardial infarction, or non-Q-wave myocardial infarction, with CK-MB≥ 2x normal and/or elevated Tn (WHO definition).
• Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization).
• Hematological abnormality, defined as: Leukopenia (WBC \<3×109/L), acute anemia (Hb \<90g/L), or thrombocytopenia (platelet count\<50×109/L), history of bleeding diathesis or coagulopathy.
• Severe ventricular insufficiency. Left ventricular ejection fraction (LVEF) \<20%.
• Echocardiographic evidence of intra-cardiac thrombus or vegetation etc.
• Active pepticulcer or upper GI bleeding within 3 months prior to the study procedure.
• Cerebral Vascular Accident (CVA) within 3 months prior to the study procedure,including TIA.
• A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine , clopidogrel and high polymer material, or sensitivity to contrast media, which cannot be adequately pre-medicated.
• Patients with infective endocarditis or other active stage of infection. Currently participating in an investigational drug or another device trial.

Sponsors & Collaborators

• Chengdu Silara Meditech Inc.: lead

MeSH Terms

Conditions

Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Jincheng Liu

  The First Affiliated Hospital,the Air Force Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Liu

CONTACT

+86 13519135591; liuyangxijing@126.com

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: June 15, 2022
• First Posted: June 21, 2022
• Study Start: August 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: August 31, 2023
• Last Updated: June 21, 2022

Record last verified: 2022-06