Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcatheter aortic valve replacement in severe aortic stenosis.
- Who it may be relevant to
- Registry conditions: Aortic Stenosis Symptomatic. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
Interventions
- Device transcatheter aortic valve replacement in severe aortic stenosis
transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis
Primary outcome measures
- Device success rate [Time frame: at 30 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peiga Medical Technology (Suzhou) Co., Ltd, Suzhou, Jiangsu 215025 — Suzhou
Publications
- 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. PMID 30883058
- 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
- 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
Identifiers
NCT: NCT06721676 · B2024-496