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

NCT06721676 | Not Yet Recruiting

• 1 other identifier: B2024-496
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Aortic Stenosis Symptomatic

Keywords

aortic stenosis; TAVI; TAVR; Function of bending

Outcome Measures

Primary Outcomes (1)

• Device success rate

  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access, artificial aortic valve delivery and release were successful, and the delivery catheter was successfully withdrawn.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)

  at 30 days

Study Arms (1)

A single arm study

EXPERIMENTAL

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

Device: transcatheter aortic valve replacement in severe aortic stenosis

Interventions

transcatheter aortic valve replacement in severe aortic stenosis DEVICE

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

A single arm study

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peijia Medical Technology (Suzhou) Co., Ltd.: lead
• Shanghai Zhongshan Hospital: collaborator

Study Sites (1)

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

Suzhou, Jiangsu, 215025, China

Location

Related Publications (3)

• 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.

  PMID: 30883058 RESULT

• 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.

  PMID: 38456886 RESULT

• 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.

  PMID: 34538602 RESULT

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Transcatheter aortic valve system 2.5 generation is a new self-expanding valve system developed by Peijia Medical. Through the improvement of the delivery device to achieve A2 flex and commissural alignment technology, it can better manage the whole life cycle of AS patients

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: December 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: June 30, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

CN (1)