Safety and Efficacy of the HighLife Transcatherter Mitral Valve Replacement System in Patients Wi… (NCT05610566) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Efficacy of the HighLife Transcatherter Mitral Valve Replacement System in Patients With Moderate-severe or Severe Mitral Regurgitation in China
China110 participantsStarted 2022-07-06
Plain-language summary
To observe and evaluate the safety and efficacy of the HighLife Transcatheter Mitral Valve Replacement System in patients with moderate-severe or severe mitral valve regurgitation through a prospective, multicenter clinical trial using objective performance criteria.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients who voluntarily participate and sign the informed consent form and can cooperate with the completion of the entire trial process;
✓. Age ≥ 18 years old;
✓. Moderate-severe or severe mitral regurgitation (≥3+); Note 1: Patients with ischemic or non-ischemic heart disease induced symptomatic secondary mitral regurgitation as the primary cause must be treated for at least 1 month after optimal guideline medical therapy (GDMT). Echocardiography should be performed 3 months after cardiac resynchronization therapy and 1 month after coronary revascularization to assess the degree of regurgitation.
✓. Patients with New York Heart Association (NYHA) functional ratings are Class II, III, or ambulatory Class IV;
✓. Anatomically appropriate for treatment with the HighLife Transcatheter Mitral Valve Replacement System.
Exclusion criteria
✕. Patients had any stroke/TIA within 30 days;
✕. Patients with severe symptomatic bilateral carotid stenosis (\>70% stenosis on non-invasive imaging);
✕. Patients with active infection requiring antibiotic therapy;
✕. Patients with active ulcer or gastrointestinal bleeding within the past 3 months;
✕. Patients with history of coagulopathy or refuse future blood transfusion;
✕. Patients unable to undergo transesophageal echocardiography (TEE);
What they're measuring
1
All-cause mortality at 12 months
Timeframe: 12 months
Trial details
NCT IDNCT05610566
SponsorPeijia Medical Technology (Suzhou) Co., Ltd.