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

NCT ID: NCT06721676

Last Updated: 2024-12-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2025-06-30

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

Conditions

Aortic Stenosis Symptomatic

Keywords

aortic stenosis; TAVI; TAVR; Function of bending

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A single arm study

The experimental apparatus consisted of artificial aortic valve, transporter and grip-loading system.the transporter has A2 flex function to improve coaxiality and commissural aligment to reduce coronary occlusion

Group Type: EXPERIMENTAL

transcatheter aortic valve replacement in severe aortic stenosis

Intervention Type: DEVICE

transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis

Interventions

transcatheter aortic valve replacement in severe aortic stenosis

transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: collaborator

Peijia Medical Technology (Suzhou) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peiga Medical Technology (Suzhou) Co., Ltd, Suzhou, Jiangsu 215025

Suzhou, Jiangsu, China

Countries

China

Facility Contacts

jing jing

Role: primary

References

Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.

Reference Type: RESULT

PMID: 30883058 (View on PubMed)

Vinayak M, Tang GHL, Li K, Berdan M, Koshy AN, Khera S, Lerakis S, Dangas GD, Sharma SK, Kini AS, Krishnamoorthy P. Commissural vs Coronary Alignment to Avoid Coronary Overlap With THV-Commissure in TAVR: A CT-Simulation Study. JACC Cardiovasc Interv. 2024 Mar 25;17(6):715-726. doi: 10.1016/j.jcin.2024.01.073. Epub 2024 Mar 6.

Reference Type: RESULT

PMID: 38456886 (View on PubMed)

Bieliauskas G, Wong I, Bajoras V, Wang X, Kofoed KF, De Backer O, Sondergaard L. Patient-Specific Implantation Technique to Obtain Neo-Commissural Alignment With Self-Expanding Transcatheter Aortic Valves. JACC Cardiovasc Interv. 2021 Oct 11;14(19):2097-2108. doi: 10.1016/j.jcin.2021.06.033. Epub 2021 Sep 15.

Reference Type: RESULT

PMID: 34538602 (View on PubMed)

Other Identifiers

B2024-496

Identifier Type: -

Identifier Source: org_study_id