A Prospective, Multicentric Clinical Trial Protocol to Evaluate the Safety and Efficacy of the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System for the Treatment of Moderate-severe or Severe Mitral Regurgitation With Single-arm Objective Performance Criteria

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

• Note 2: For patients with primary mitral regurgitation, the multidisciplinary cardiac team of the research center needs to use a standard scoring system, considering multiple factors such as complications, frailty, and disability, ensuring the enrolled with a high risk of surgery.

• 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.

Locations
Other Locations
China
Peiga Medical Technology (Suzhou) Co.
RECRUITING
Suzhou
Contact Information
Primary
Kejing Yi
yikejing@peijiamedical.com
+86-13801858760
Time Frame
Start Date: 2022-07-06
Estimated Completion Date: 2029-07-06
Participants
Target number of participants: 110
Treatments
Experimental: A single set of test
The HighLife Trans-Septal TMVR System comprises a 28mm Transcatheter Mitral Valve, a loop placement catheter, a sub-annular implant and its delivery systems.
Related Therapeutic Areas
Sponsors
Collaborators: Second Affiliated Hospital, School of Medicine, Zhejiang University, West China Hospital, The Second Affiliated Hospital of Harbin Medical University
Leads: Peijia Medical Technology (Suzhou) Co., Ltd.

This content was sourced from clinicaltrials.gov