Severe Aortic Stenosis, Transcatheter Aortic Valve Replacemen
Conditions
Brief summary
This is a prospective, single-arm, multi-center, post-market registry study conducted in China. The purpose is to evaluate the safety and effectiveness of the AlwideTM Plus balloon catheter for pre-dilatation of the aortic valve during TAVR in the real-world setting.
Detailed description
The study is designed to evaluate the safety and effectiveness of the Alwide Plus balloon catheter for pre-dilatation of the aortic valve during in transcatheter aortic valve replacement in the real-world setting, with TAVI device success at immediate post-procedure as the primary endpoint. The immediate post-procedural pre-dilation success, all-cause mortality, stroke, bleeding, acute kidney injury, permanent pacemaker implantation, major vascular complication, valve function at post-procedure and discharge, and post-dilation success will be used as secondary endpoints.This is a prospective, multi-center, post market clinical investigation. 75 patients will be enrolled in this clinical investigation. All subjects will undergo telephone follow-up at 30 days post-procedure.
Interventions
None listed
Sponsors
Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age≥18 years old; * Severe aortic stenosis verified by echocardiogram: mean transvalvular gradient≥40mmHg (1mmHg=0.133kPa), or peak aortic jet velocity≥4m/s, or aortic valve area (AVA) ≤ 1.0cm2 (or AVA index≤ 0.6cm2/m2); * Patients, who can understand the clinical investigation purpose, voluntary agree and sign the informed consent form, and willing to comply with relevant trial assessments and clinical follow up
Exclusion criteria
* Aortic valve anatomy or lesion unsuitable or not necessary for balloon pre-dilation during the TAVR procedure * TAVR procedure in trans-apical access * Pre-implanted mechanical or bioprosthetic valve at the aortic valve position * Acute myocardial infarction (MI) occurred in the last 30 days before the treatment； * LVOT obstruction; * Serious left ventricular dysfunction with left ventricular ejection fraction (LVEF) \<20% * Echocardiographic evidence of intracardiac mass, thrombus or neoplasm； * Unable to receive anticoagulation or antiplatelet therapy； * Allergy to nitinol or sensitive contrast media； * Active bacterial endocarditis or other active infection may affect the procedure； * Aortic valve anatomy , lesion, or other situation unsuitable for the prosthesis valve implantation as assessed by the investigator team； * Life expectancy \> 12 months； * vulnerable individuals who are unable to give informed consent/ unable to fully understand all aspects of the investigation or Severe incapacitating Alzheimer's disease； * Patients who participated in other clinic trials of drugs or medical device before being enrolled for which the primary endpoint follow up duration has not been reached； * Investigators determined that patients have poor compliance and can't complete the study as required
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with TAVI device success at immediate post-procedure | Immediate post-procedure | TAVI device success, defined as (meeting all the following criteria): Freedom from mortality; Successful access, delivery, deployment, implantation of the valve, and retrieval of the delivery system; Correct positioning of the prosthetic heart valve into the proper anatomical location; Intended performance of the valves (mean gradient \<20mmHg, or peak velocity \<3 m/s, and no severe aortic regurgitation or paravalvular leakage). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of all-cause mortality, disabling and non-disabling stroke, life-threatening or disabling bleeding, major bleeding, acute kidney injury(AKIN≥2), major vascular complications and new permanent pacemaker implantation | Immediate post-procedure and 30 days post-procedure | Definition following VARC-2 criteria |
| Prosthetic valve performance-mean transvalular pressure gradient | Immediate post-procedure and discharge(within 7 days post-procedure) | Prosthetic valve performance-mean pressure gradient(assessed by echocardiography), unit -mmHg |
| Prosthetic valve performance-orifice area | Immediate post-procedure and discharge(within 7 days post-procedure) | Prosthetic valve performance-orifice area(assessed by echocardiography), unit -cm2 |
| Prosthetic valve performance-valve regurgitation(intra- and para valvular leakage) | Immediate post-procedure and discharge(within 7 days post-procedure) | Prosthetic valve performance-valve regurgitation(intra- and para valvular leakage), none/trace/mild/moderate/severe |
| Percentage of patients with balloon pre-dilation success | Immediate post-procedure | defined as successful access, delivery and dilation the aortic valve, and retrieval for the AlwideTM Plus balloon catheter |
| Percentage of paitents with balloon post-dilation success | Immediate post-procedure | defined as successful access, delivery and dilation the transcatheter aortic valve, and retrieval for the AlwideTM Plus balloon catheter |
Countries
China
Outcome results
None listed