Actively Recruiting
Safety and Efficacy of the HighLife Transcatherter Mitral Valve Replacement System in Patients With Moderate-severe or Severe Mitral Regurgitation in China
Led by Peijia Medical Technology (Suzhou) Co., Ltd. · Updated on 2022-11-09
110
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
Sponsors
P
Peijia Medical Technology (Suzhou) Co., Ltd.
Lead Sponsor
W
West China Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of the HighLife Transcatherter Mitral Valve Replacement System in Patients With Moderate-severe or Severe Mitral Regurgitation in China
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who voluntarily participate and sign the informed consent form and can cooperate with the entire trial process
- Age 18 years or older
- Moderate-severe or severe mitral regurgitation (grade 3+ or higher)
- For secondary mitral regurgitation: treated for at least 1 month after optimal guideline medical therapy and assessed by echocardiography after resynchronization therapy or revascularization
- For primary mitral regurgitation: assessed by a multidisciplinary cardiac team to have high surgical risk
- New York Heart Association functional class II, III, or ambulatory IV
- Anatomically suitable for treatment with the HighLife Transcatheter Mitral Valve Replacement System
You will not qualify if you...
- Stroke or transient ischemic attack within 30 days
- Severe symptomatic bilateral carotid stenosis (over 70%)
- Active infection requiring antibiotics
- Active ulcer or gastrointestinal bleeding within past 3 months
- History of coagulopathy or refusal of blood transfusion
- Unable to undergo transesophageal echocardiography
- Pregnant, breastfeeding, or planning pregnancy within 12 months
- Unable to follow-up or complete examinations
- Currently enrolled in other clinical studies
- Allergy to device components or contrast agents
- Unable to receive anticoagulant or antiplatelet therapy
- Life expectancy less than 12 months due to non-cardiac disease
- Need for emergency surgical treatment
- Scheduled cardiac surgery within 12 months
- Mitral annulus or leaflet size less than 30mm or greater than 45mm
- Moderate or above mitral stenosis
- Flail mitral leaflets or moderate to severe mitral valve prolapse
- Severe liver or kidney failure
- Severe calcification of mitral annulus or leaflets
- History of mitral valve surgery or interventional therapy
- Acute myocardial infarction within past 1 month
- Untreated symptomatic coronary lesions needing revascularization
- Untreated severe aortic stenosis or regurgitation
- Presence of aortic valve prosthesis
- Severe tricuspid valve disease requiring surgery
- Significant right ventricular dysfunction
- Left ventricular ejection fraction less than 30% or left ventricular end-diastolic diameter over 70mm
- Intracardiac mass, thrombus, or tumor
- Hypertrophic obstructive cardiomyopathy
- Active or recent endocarditis within 3 months
- Severe pulmonary hypertension not caused by left heart disease
- Low blood pressure (systolic less than 90 mmHg) within 7 days or need for mechanical hemodynamic support
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peiga Medical Technology (Suzhou) Co.
Suzhou, Jiangsu, China, 215025
Actively Recruiting
Research Team
K
Kejing Yi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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