Clinical trial NCT04414865: VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study
Official title: A Prospective, Multi-center, Post-market Registry Study Evaluating Safety and Effectiveness of the Microport™CardioFlow VitaFlow™Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Stenosis
Lead sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-04
Enrollment: 100
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes symptomatic patients (≥70 years old ) with calcified, severe, degenerative, native aortic valve stenosis who are not suitable for the surgical aortic valve replacement as assessed by the heart team

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.

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.

Eligibility criteria: Inclusion Criteria:

* Age≥70 years;
* 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);
* The patients considered to be not suitable for surgical aortic valve replacement (SAVR);
* 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:

* Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve；
* Vascular diseases or anatomical condition preventing the device access；
* Previous implantation of mechanical or bioprosthesis valve in the aortic position；
* Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements；
* Ongoing sepsis, including active endocarditis；
* Estimated Life expectancy\< 12 months；
* Participating in another trial and the primary endpoint is not achieved.
* Inability to comply with the clinical investigation follow-up or other requirements.

Primary outcomes:
measure: Rate of all-cause mortality at 12 months post implantation
timeFrame: 12 months post implantation
Secondary outcomes:
measure: Valve function-mean transvalvular gradient
timeFrame: at discharge, 30 days, 1 year and annually up to 5 years post implantation
measure: Valve function-effective orifice area
timeFrame: at discharge, 30 days, 1 year and annually up to 5 years post implantation
measure: Valve function-degree of prosthetic valve regurgitation
timeFrame: at discharge, 30 days, 1 year and annually up to 5 years post implantation
measure: Rate of safety events according to VARC2
timeFrame: at immediate, 30 days, 1 year and annually up to 5 years post implantation
measure: Rate of other TAVI-related complications
timeFrame: at immediate, 30 days, 1 year and annually up to 5 years post implantation
measure: Rate of device success
timeFrame: at immediate post implantation
measure: Rate of balloon pre-dilatation success
timeFrame: at immediate post implantation
measure: Rate of balloon post-dilatation success
timeFrame: at immediate post implantation
measure: Rate of procedure success
timeFrame: at immediate post implantation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijing Hospital，Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
References: