PrizValve® Transcatheter Aortic Valve Replacement Study

Evaluation of the Efficacy and Safety of the Transcatheter Aortic Valve Replacement System in Patients With Severe Aortic Valve Stenosis Disease at High Surgical Risk

The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not suitable for surgery.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: PrizValve® valve and transapical delivery system

Detailed Description

This study is an multicenter, single-arm, prospective, safety and performance clinical study.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan, China
    • Department of Cardiology, West China Hospital, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 65 years ;
2. Patients with symptomatic severe aortic valve stenosis (evaluated by echocardiography: transaortic valve pressure gradient ≥40mmHg (1mmHg=0.133kPa), or transaortic valve blood flow rate ≥4m/s, or aortic Valve area<1.0cm2, or AVA <0.5cm2 /m2);
3. NYHA ≥ II;
4. Life expectancy> 12 months;
5. Patients who are anatomically suitable for transcatheter aortic valve implantation;
6. After evaluation by two or more cardiovascular surgeons, patients who are unsuitable for surgery; or patients who refuse surgery after sufficient communication by the surgeons and are at high risk of routine surgery;
7. Patients who can understand the purpose of the trial, voluntarily participate in and signed informed consent form, and are willing to accept relevant examinations and clinical follow-ups.

Exclusion Criteria:

1. Acute myocardial infarction occurred within 1 month before this treatment;
2. Congenital single leaf aortic valve;
3. Any therapeutic cardiac operation (including placement of coronary drug-eluting stents) within 30 days;
4. The patient's heart has been implanted with other artificial heart valves, artificial rings, or severe mitral regurgitation (>3+);
5. Blood system diseases or abnormalities, including leukopenia (WBC<3×109/L), acute anemia (HB <90g/L), thrombocytopenia (PLT<50×109/L), bleeding constitution and coagulopathy ；
6. Untreated severe coronary artery stenosis that requires revascularization;
7. Patients with hemodynamic or respiratory instability, requiring continuous mechanical heart assistance or mechanical ventilation;
8. Patients who need emergency surgery for any reason;
9. Hypertrophic cardiomyopathy with obstruction;
10. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%;
11. The echocardiogram indicates the presence of a heart mass, thrombus or vegetation;
12. A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months;
13. Are allergic to cobalt-chromium alloys or contrast agents, and cannot tolerate anticoagulation and antiplatelet therapy;
14. The diameter of the aortic valve annulus <16mm or >28mm;
15. In any case, patients who refuse surgical treatment in emergency situations;
16. Cerebrovascular accident occurred within 3 months, not including transient ischemic attack;
17. Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, obvious curvature of the aortic arch, atherosclerosis of the aortic arch, narrowing of the abdominal or thoracic aorta, and obvious curvature or extension of the thoracic aorta;
18. The iliac-femoral artery is severely obstructed with calcification, severely tortuous or unable to place the 1418F catheter sheath kit;
19. Active infective endocarditis or other active infections;
20. Aortic valve leaflets calcified plaque close to the coronary ostium;
21. Severe disability Alzheimer's disease and unable to take care of oneself in life;
22. Those who have participated in clinical trials of other drugs or medical devices before entering the group and have not yet reached the time limit of the primary research endpoint;
23. The researcher judged that the patient had poor compliance and could not complete the study as required.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Transcatheter aortic valve replacement	Device: PrizValve® valve and transapical delivery system; Transcatheter aortic valve replacement system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from all-cause mortality	All-cause mortality within 12 months of TAVI procedure	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from all-cause mortality	All-cause mortality within 2-5 years of TAVI procedure	2-5 years
Device success	Device success after TAVI	immediate post-surgical
Procedural success	Procedural success after TAVI	immediate post-surgical
Rate of Myocardial infarction	Rate of Myocardial infarction after TAVI	30 days、6 months、1-5 years
Rate of All disabling stroke	Rate of All disabling stroke after TAVI	30 days、6 months、1-5 years
Rate of Severe bleeding	Rate of Severe bleeding after TAVI	30 days、6 months、1-5 years

Collaborators and Investigators

• Sponsor: Shanghai NewMed Medical Co., Ltd.
• Investigators: Study Chair: Chen mao, Chief, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2021
• Primary Completion (Actual): June 19, 2023
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: A-valve-2020-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No