Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis

Not Applicable

Not yet recruiting

• Conditions: Aortic Stenosis Symptomatic

• Registration Number: NCT06721676
• Lead Sponsor: Peijia Medical Technology (Suzhou) Co., Ltd.

Brief Summary

A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medical

Detailed Description

A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medica.Patients are seen at pre and post procedure, discharge, 30 days. The main follow-up included clinical symptoms and signs, cardiac ultrasound, CT, etc. The outcome include immediate device success, procedure success and device sucess. The secondary end points include ：1) Immediate postoperative ultrasound evaluation of different sinus valve implantation depths.2) realization rate of commissural alignment was evaluated by ultrasound immediately after operation.3) the incidence of ≥ moderate paravalvular regurgitation assessed by ultrasound at 30 days after surgery.

4) CT assessment of different sinus valve implantation depths at 30 days after surgery.5) CT was performed 30 days after operation to evaluate the realization rate of commissural alignment and coronary artery alignment

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-05-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients who are willing to participate and sign the informed consent and can cooperate with the whole trial process;
• Age ≥60 years old;
• Patients with severe calcified aortic stenosis confirmed by echocardiography (trans-aortic valve flow velocity ≥ 4.0m /s, or trans-active valvular pressure difference ≥40mmHg (1mmHg=0.133kPa), or aortic valve orientation area < 0.8cm2, or effective aortic valve orifice the product index is < 0.5cm2/m2);
• The cardiac team (at least two specialists in cardiovascular surgery) assessed the patient as unsuitable for routine surgery ;
• The aortic angel ≥60 degree.

Exclusion Criteria

• The left and right coronary ostiums originate from the junctional zone or from both coronary ostiums;
• previous CABG history;
• Coronary ostial lesions（PCI or not）;
• Prior aortic valve prosthesis implantation (interventional/surgical, bioprosthetic/mechanical);
• Spoor peripheral arterial condition precluded transfemoral TAVR;
• Severe coronary stenoses requiring intervention for which concomitant PCI is not possible;
• Concomitant diseases requiring cardiac surgery;
• Other serious diseases that may reduce life expectancy to less than 12 months (e.g. clinically recurrent or metastatic cancer, congestive heart failure, etc.);
• contraindications to conventional cardiac catheterization, such as intracardiac thrombosis, infection, outflow obstruction, hypertrophic cardiomyopathy, etc;
• other surgical anatomical contraindications, such as the risk of coronary artery occlusion;
• clinically significant active bleeding
• platelet count < 30×10/ L;
• participating in other drug or medical device clinical studies that have not yet been completed ;
• considered inappropriate by the investigator to participate in the clinical study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Device success rate	at 30 days	Device success is defined as - Vascular access, artificial aortic valve delivery and release were successful, and the delivery catheter was successfully withdrawn. - The artificial aortic valve was implanted in an anatomically accurate position. - The artificial aortic valve met the expected requirements (mean transvalvular pressure difference \< 20mmHg or maximum flow rate \< 3m/s; Doppler velocity index \>_0.25,and less than moderate aortic regurgitation)

Trial Locations

Locations (1)

Peiga Medical Technology (Suzhou) Co., Ltd, Suzhou, Jiangsu 215025; 🇨🇳 Suzhou, Jiangsu, China