VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study
Study Details
Study Description
Brief Summary
The study objective is to evaluate safety and effectiveness/performance of the Microport™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis in the real world settings.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This is a prospective, single-arm, multi-center, observational, post-market registry study. The purpose is to evaluate the safety, performance, and effectiveness of the VitaFlow™ Transcatheter Aortic Valve System in the real world settings.Patients will be seen at pre and post procedure, discharge, 30 days, 1 year and annually up to 5 years.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| single arm, treatment group Subjects in the treatment group will be implanted with the VitaFlow™ Transcatheter Aortic Valve System |
Device: VitaFlow™ Transcatheter Aortic Valve System
VitaFlow™ Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System,loading tools, a balloon dilatation catheter, and an introducer set
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Outcome Measures
Primary Outcome Measures
- Rate of all-cause mortality at 12 months post implantation [12 months post implantation]
Rate of all-cause mortality including cardiovascular and non-cardiovascular death
Secondary Outcome Measures
- Valve function-mean transvalvular gradient [at discharge, 30 days, 1 year and annually up to 5 years post implantation]
Mean transvalvular gradient measured by transthoracic echocardiography (TTE)(in mmHg)
- Valve function-effective orifice area [at discharge, 30 days, 1 year and annually up to 5 years post implantation]
Effective orifice area measured by transthoracic echocardiography (TTE)(in cm^2)
- Valve function-degree of prosthetic valve regurgitation [at discharge, 30 days, 1 year and annually up to 5 years post implantation]
Degree of prosthetic valve regurgitation, including paravalvular leak and intravalvular regurgitation measured by transthoracic echocardiography (TTE)
- Rate of safety events according to VARC2 [at immediate, 30 days, 1 year and annually up to 5 years post implantation]
Rate of safety events according to VARC2 including all-cause mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, new permanent pacemaker implantation
- Rate of other TAVI-related complications [at immediate, 30 days, 1 year and annually up to 5 years post implantation]
Rate of other TAVI-related complications including conversion to open surgery, unplanned use of cardiopulmonary bypass, coronary obstruction, ventricular septal perforation, mitral valve apparatus damage or dysfunction, cardiac tamponade, endocarditis, valve thrombosis, valve mal-positioning, TAV-in-TAV, valve related dysfunction requiring repeat procedure (TAVI,SAVR,BAV)
- Rate of device success [at immediate post implantation]
Rate of device success, assessed by the access, delivery, deployment and implantation of the device and the prosthetic valve function
- Rate of balloon pre-dilatation success [at immediate post implantation]
Rate of balloon pre-dilatation success, assessed by the access, delivery, pre-dilatation and retrieval of the balloon catheter
- Rate of balloon post-dilatation success [at immediate post implantation]
Rate of balloon pre-dilatation success, assessed by the access, delivery, post-dilatation and retrieval of the balloon catheter
- Rate of procedure success [at immediate post implantation]
Rate of procedure success, assessed by the device success and peri-procedural complications
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age≥70 years;
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Symptomatic , calcified, severe, degenerative, native aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or aortic valve area<0.8cm² (or EOA index<0.5cm²/m²);
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The patients considered to be not suitable for surgical aortic valve replacement (SAVR);
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The patient has been informed of the nature of the study, is willing to enroll in the study by signing a patient informed consent and agreeing to the scheduled follow up requirement.
Exclusion Criteria:
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Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve；
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Vascular diseases or anatomical condition preventing the device access；
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Previous implantation of mechanical or bioprosthesis valve in the aortic position；
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Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements；
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Ongoing sepsis, including active endocarditis；
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Estimated Life expectancy< 12 months；
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Participating in another trial and the primary endpoint is not achieved.
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Inability to comply with the clinical investigation follow-up or other requirements.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ruijing Hospital，Jiaotong University School of Medicine | Shanghai | Shanghai | China | |
| 2 | Zhongshan Hospital | Shanghai | Shanghai | China |
Sponsors and Collaborators
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LAUNCH-2020