Structural Heart Surgery Assist System for Transcatheter Mitral Valve Edge-to-Edge Repair (TEER).
Recruiting
N/A
Interventional Study
Mitral R
Mitral Regurgitation
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 112 (estimated)
- Sponsor
- Xiamen Cardiovascular Hospital, Xiamen University · Other
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About This Trial
This trial aims to evaluate the safety and efficacy of the Structural Heart Surgery Assist System in assisting TEER for patients with moderate-to-severe or greater degenerative or functional mitral regurgitation (MR ≥3+). A prospective, multicenter, stratified randomized controlled design with non-inferiority comparison will be used. The experimental group will utilize the Structural Heart Surgery…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age ≥18 years, regardless of gender.
2. Symptomatic moderate-to-severe or greater mitral regurgitation (MR ≥3+) confirmed by transthoracic and/or transesophageal echocardiography (TTE/TEE), with planned transcatheter edge-to-edge repair (TEER):
For degenerative mitral reg…
Contacts