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

Aortic Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05424653
• Other study ID #: Silara202101
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: June 2022
• Source: Chengdu Silara Meditech Inc.
• Contact: Yang Liu
• Phone: +86 13519135591
• Email: liuyangxijing[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Transcatheter Aortic Valve System (Chengdu Silara Medtech Inc. ,Chengdu, China) will be used for this study. To evaluate the feasibility , safety and effectiveness of Transcatheter aortic valve system.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: August 31, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. Age = 60 years old;

2. Subjects with symptomatic severe aortic valve regurgitation.

3. NYHA Functional Class =II.

4. Life expectancy after aortic valve implantation thought to be >1 year,

5. Native valvular or peripheral vascular anatomy is appropriate for TAVR.

6. 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.

7. 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.

Exclusion Criteria:

1. 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

2. 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).

3. Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization).

4. 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.

5. Severe ventricular insufficiency. Left ventricular ejection fraction (LVEF) <20%.

6. Echocardiographic evidence of intra-cardiac thrombus or vegetation etc.

7. Active pepticulcer or upper GI bleeding within 3 months prior to the study procedure.

8. Cerebral Vascular Accident (CVA) within 3 months prior to the study procedure,including TIA.

9. 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.

10. Patients with infective endocarditis or other active stage of infection. Currently participating in an investigational drug or another device trial.

Related Conditions & MeSH terms

• Aortic Insufficiency
• Aortic Valve Insufficiency

Intervention

Device:
• Transcatheter Aortic Valve System
Procedure: Transcatheter Aortic Valve Replacement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu Silara Meditech Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Rate of none or trace AR		30 days
Primary	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
Primary	Incidence of MACCE	MACCE includs death, stroke, MI, re-procedure, conduction disturbances and cardiac arrhythmias	30 days
Secondary	Delivery system performance	Delivery System Performance wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor.	Immediate post-procedure
Secondary	Retrieval system performance (if need)	Retrieval System Performance wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor.	Immediate post-procedure
Secondary	Exchange system evaluation	Exchange Systerm Evaluation wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor.	Immediate post-procedure
Secondary	Valvular function evaluation, including valve stenosis, AR, valve function(e.g. EOA, gradient) and PVL	The evaluation criteria refer to the 2012 edition of the Association for Valvular Academic Research (VARC-2) consensus document	Immediate post-procedure, 7 days or discharge, 30 days, 6 months and 12months
Secondary	Quality of Life Assessment	SF-12	30 days, 6 months,and 12 months
Secondary	NYHA function		7 days or discharge, 30 days, 6 months ,12 months
Secondary	All-cause Mortality		Immediate post- procedure ,7 days /discharge, 6 months and 12 months
Secondary	Rate of moderate to severe AR		immediate post- procedure ,7 days /discharge, 6 months and 12 months
Secondary	Incidence of Myocardial Infarction		immediate post- procedure, 7 days /discharge, 30 days, 6 months and 12months
Secondary	Incidence of MACCE	including death, stroke, MI, re-procedure, Conduction disturbances and cardiac arrhythmias	Immediate post- procedure, 7 days /discharge, 6 months and 12months.
Secondary	Incidence of Bleeding(life-threatening or disabling and major)		Immediate post- procedure, 7 days /discharge, 30 days, 6 months and 12 months
Secondary	Incidence of stroke		7 days /discharge, 30 days, 6 months and 12 months
Secondary	Incidence of AKI	including AKIN stage 2 and 3,or renal replacement therapy (RRT:Hemodialysis, abdomen Cavity dialysis, hemofiltration)	7 days /discharge, 30 days, 6 months and 12 months
Secondary	Incidence of Permanent Pacemaker Implantation		7 days /discharge, 30 days, 6 months and 12 months
Secondary	Incidence of major vascular complications		Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months
Secondary	Incidence of Conduction disturbances and cardiac arrhythmias		Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months
Secondary	Incidence of other TAVI-related complications	including transfer to surgery , accidental heart-lung machine, coronary obstruction, ventricular septal rupture, mitral valve damage or dysfunction,cardiac tamponade,endocarditis ,valvular thrombus,valve migration(shifting, detachment, embolism, error deployment),valve in valve	at immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month