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Safety and Feasibility of TRISKELE in Severe AS

Primary Purpose

Aortic Valve Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MitrAssist TRISKELE® transcatheter aortic valve system
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Disease

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 70 years old;
  2. 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);
  3. Patients with biological valve decay meeting the criteria in (2) above;
  4. NYHA grade ≥ grade II;
  5. The life expectancy after artificial valve implantation is more than 1 year;
  6. Patients who are anatomically suitable for transcatheter aortic valve implantation;
  7. Two or more cardiothoracic surgeons evaluate and record it as surgical contraindication or as high-risk surgery and unsuitable for routine surgery;
  8. 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.

Exclusion Criteria:

  1. 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);
  2. Patients whose aortic root anatomy and lesions are not suitable for artificial valve implantation;
  3. Compound aortic valve disease (aortic stenosis with severe regurgitation); Severe mitral regurgitation;
  4. Hematological malignancies, hemophilia and other coagulation disorders;
  5. Hemodynamic instability, requiring mechanical cardiac assistance;
  6. Emergency operation for any reason;
  7. Obstructive hypertrophic cardiomyopathy;
  8. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) < 30%;
  9. Severe right ventricular dysfunction;
  10. Echocardiography showed the presence of intracardiac mass, thrombus or vegetations;
  11. Active peptic ulcer or upper gastrointestinal hemorrhage within 3 months;
  12. Allergic to nickel titanium alloy, stainless steel alloy, PU (polyurethane), or contrast agent; Unable to tolerate anticoagulant and antiplatelet therapy;
  13. Cerebrovascular events (CVA) occurred within 3 months, including ischemic stroke and hemorrhagic stroke, excluding transient ischemic attack (TIA);
  14. Vascular diseases affecting the instrument approach;
  15. Infective endocarditis in active phase or other active infections;
  16. Those who have participated in clinical trials of other drugs or medical devices before enrollment and have not reached the time limit of the main research endpoint.

Sites / Locations

  • Zhongshan Hopital of Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MitrAssist TRISKELE® transcatheter aortic valve system

Arm Description

Device: MitrAssist TRISKELE® transcatheter aortic valve system

Outcomes

Primary Outcome Measures

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
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)

Secondary Outcome Measures

Early safety endpoint
Freedom from all-cause mortality; Freedom from all stroke; Freedom from VARC type 2-4 bleeding (in trials where control group is surgery, it is appropriate to include only Type 3 and 4 bleeding); Freedom from major vascular, access-related, or cardiac structural complication; Freedom from acute kidney injury stage 3 or 4; Freedom from moderate or severe aortic regurgitation; Freedom from new permanent pacemaker due to procedure-related conduction abnormalities; Freedom from surgery or intervention related to the device
six minute walk distance (6MWD) test
The six minute walk distance (6MWD) test (see Appendix II) was used to record the patients' six minute walk distance before operation and 30 days after operation. The six minute walk test is mainly used to evaluate the efficacy of treatment intervention in patients with moderate and severe cardiovascular diseases, and can objectively reflect the actual daily activity ability
The quality of life improved 30 days after operation
SF-12 quality of life table was used to score the cardiac function improvement before discharge and 30 days after operation. NYHA classification scheme was adopted for the classification of cardiac function.

Full Information

First Posted
May 22, 2022
Last Updated
July 11, 2022
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05391191
Brief Title
Safety and Feasibility of TRISKELE in Severe AS
Official Title
Prospective Clinical Study on the Safety and Clinical Feasibility of Exploring TRISKELE® Transcatheter Aortic Valve System in the Treatment of Severe Aortic Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
This study was a prospective、single arm clinical trial design. For patients with surgical contraindications or high-risk symptomatic severe aortic stenosis, MitrAssist TRISKELE® transcatheter aortic valve system was performed by aortic valve replacement. Patients were followed up 30 days (± 7 days) after operation for the feasibility and safety analysis to explore the test device in patients with surgical contraindications or high-risk symptomatic severe aortic stenosis.In this study, a clinical trial institution meeting the national qualification is planned to be selected as the clinical research center, and 7 patients are planned to be selected. The success rate of operation 30 days after operation was taken as the main evaluation index and the success of device implantation, the result of echocardiography evaluation of valve function, the improvement rate of NYHA cardiac function classification, six minute walking distance and the score of Kansas City Cardiomyopathy Questionnaire were taken as the secondary evaluation indexes, to evaluate clinical effectiveness of TRISKELE® transcatheter aortic valve system; Adverse events, serious adverse events, major cardiovascular and cerebrovascular adverse events, device defects, vital signs and laboratory examination results were used as safety indicators to evaluate the safety of the test device .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MitrAssist TRISKELE® transcatheter aortic valve system
Arm Type
Experimental
Arm Description
Device: MitrAssist TRISKELE® transcatheter aortic valve system
Intervention Type
Device
Intervention Name(s)
MitrAssist TRISKELE® transcatheter aortic valve system
Intervention Description
Patients were treated with MitrAssist TRISKELE® transcatheter aortic valve system
Primary Outcome Measure Information:
Title
Technical success
Description
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
Time Frame
at exit from procedure room
Title
Device success
Description
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)
Time Frame
within 30 days after operation
Secondary Outcome Measure Information:
Title
Early safety endpoint
Description
Freedom from all-cause mortality; Freedom from all stroke; Freedom from VARC type 2-4 bleeding (in trials where control group is surgery, it is appropriate to include only Type 3 and 4 bleeding); Freedom from major vascular, access-related, or cardiac structural complication; Freedom from acute kidney injury stage 3 or 4; Freedom from moderate or severe aortic regurgitation; Freedom from new permanent pacemaker due to procedure-related conduction abnormalities; Freedom from surgery or intervention related to the device
Time Frame
within 30 days after operation
Title
six minute walk distance (6MWD) test
Description
The six minute walk distance (6MWD) test (see Appendix II) was used to record the patients' six minute walk distance before operation and 30 days after operation. The six minute walk test is mainly used to evaluate the efficacy of treatment intervention in patients with moderate and severe cardiovascular diseases, and can objectively reflect the actual daily activity ability
Time Frame
within 30 days after operation
Title
The quality of life improved 30 days after operation
Description
SF-12 quality of life table was used to score the cardiac function improvement before discharge and 30 days after operation. NYHA classification scheme was adopted for the classification of cardiac function.
Time Frame
within 30 days after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; Those who have participated in clinical trials of other drugs or medical devices before enrollment and have not reached the time limit of the main research endpoint.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
XIAOCHUN ZHANG, MD
Phone
8615002121366
Email
zhang.xiaochun1@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JUNBO GE, PHD
Organizational Affiliation
Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan Hopital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
XIAOCHUN ZHANG, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Feasibility of TRISKELE in Severe AS

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