Safety and Feasibility of TRISKELE in Severe AS

NCT05391191 | Unknown

• 1 other identifier: TRISKELE
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study is a prospective、single arm and exploratory study, to explore the feasibility and safety of MitrAssist TRISKELE® transcatheter aortic valve system in the treatment of patients with severe aortic stenosis.

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (2)

• Technical success

  Freedom from mortality; Successful access, delivery of the device, and retrieval of the delivery System; Correct positioning of a single prosthetic heart valve into the proper anatomical location; Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication

  at exit from procedure room

• Device success

  Technical success; Freedom from mortality; Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication; Intended performance of the valve (mean gradient \<20 mmHg, peak velocity\<3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation)

  within 30 days after operation

Secondary Outcomes (3)

• Early safety endpoint

  within 30 days after operation

• six minute walk distance (6MWD) test

  within 30 days after operation

• The quality of life improved 30 days after operation

  within 30 days after operation

Study Arms (1)

MitrAssist TRISKELE® transcatheter aortic valve system

EXPERIMENTAL

Device: MitrAssist TRISKELE® transcatheter aortic valve system

Device: MitrAssist TRISKELE® transcatheter aortic valve system

Interventions

MitrAssist TRISKELE® transcatheter aortic valve system DEVICE

Patients were treated with MitrAssist TRISKELE® transcatheter aortic valve system

MitrAssist TRISKELE® transcatheter aortic valve system

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 70 years old;
• Patients with symptomatic severe aortic stenosis (echocardiographic mean pressure gradient across aortic valve ≥ 40mmhg, or blood flow velocity across aortic valve ≥ 4.0m/s, or aortic valve area \< 0.8cm2, or effective aortic valve area index \< 0.5cm2/m2);
• Patients with biological valve decay meeting the criteria in (2) above;
• NYHA grade ≥ grade II;
• The life expectancy after artificial valve implantation is more than 1 year;
• Patients who are anatomically suitable for transcatheter aortic valve implantation;
• Two or more cardiothoracic surgeons evaluate and record it as surgical contraindication or as high-risk surgery and unsuitable for routine surgery;
• Patients who can understand the purpose of the trial, voluntarily participate in and sign informed consent, and are willing to accept relevant examination and clinical follow-up.

You may not qualify if:

• Acute myocardial infarction occurred within 30 days before this treatment (WHO definition: Q-wave MI, or non-Q-wave MI with elevated creatine kinase isoenzyme and troponin T);
• Patients whose aortic root anatomy and lesions are not suitable for artificial valve implantation;
• Compound aortic valve disease (aortic stenosis with severe regurgitation); Severe mitral regurgitation;
• Hematological malignancies, hemophilia and other coagulation disorders;
• Hemodynamic instability, requiring mechanical cardiac assistance;
• Emergency operation for any reason;
• Obstructive hypertrophic cardiomyopathy;
• Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) \< 30%;
• Severe right ventricular dysfunction;
• Echocardiography showed the presence of intracardiac mass, thrombus or vegetations;
• Active peptic ulcer or upper gastrointestinal hemorrhage within 3 months;
• Allergic to nickel titanium alloy, stainless steel alloy, PU (polyurethane), or contrast agent; Unable to tolerate anticoagulant and antiplatelet therapy;
• Cerebrovascular events (CVA) occurred within 3 months, including ischemic stroke and hemorrhagic stroke, excluding transient ischemic attack (TIA);
• Vascular diseases affecting the instrument approach;
• Infective endocarditis in active phase or other active infections;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hopital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• JUNBO GE, PHD

  Fudan University

  STUDY CHAIR

Central Study Contacts

XIAOCHUN ZHANG, MD

CONTACT

8615002121366; zhang.xiaochun1@zs-hospital.sh.cn

Study Design

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

Study Record Dates

• First Submitted: May 22, 2022
• First Posted: May 25, 2022
• Study Start: July 6, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)