Evaluating the VitaFlow™ Transcatheter Aortic Valve System for severe aortic stenosis

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

This study is testing a new heart valve system to see if it safely helps people with severe aortic stenosis who can't have traditional surgery.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 70 Years and up
• Sex: All
• Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT04414865 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the safety and effectiveness of the VitaFlow™ Transcatheter Aortic Valve System in treating severe aortic stenosis in real-world settings. It is a prospective, single-arm, multi-center registry that will follow patients before and after the procedure, with evaluations at discharge, 30 days, 1 year, and annually up to 5 years. The study includes patients who are not suitable for surgical aortic valve replacement and focuses on gathering data on the valve's performance and patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 70 years and older with symptomatic, severe aortic valve stenosis who are deemed unsuitable for surgical aortic valve replacement.

Not a fit: Patients with unsuitable aortic root anatomy, vascular diseases preventing device access, or those with ongoing infections will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for patients with severe aortic stenosis who are not candidates for traditional surgery.

How similar studies have performed: Other studies have shown success with similar transcatheter valve approaches, indicating a promising avenue for treatment.

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.

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Ruijing Hospital，Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Zhongshan Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Zhujun Cai, PhD

Conditions Aortic Valve Stenosis