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

December 3, 2024 updated by: Peijia Medical Technology (Suzhou) Co., Ltd.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215025
        • Peiga Medical Technology (Suzhou) Co., Ltd, Suzhou, Jiangsu 215025
        • Contact:
        • Sub-Investigator:
          • daxin zhou, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: transcatheter aortic valve replacement in severe aortic stenosis
transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device success rate
Time Frame: 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)
at 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peijia Medical Technology (Suzhou) Co., Ltd.

Collaborators

Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Estimated)

December 6, 2024

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2024-496

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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