MitraClip EXPAND G4 Study
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Details and patient eligibility
About
This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.
Full description
This is a post-market, multi-center, single-arm, prospective study to assess the safety and performance of the next generation MitraClip G4 System. The current protocol describes the design of this post-market study.
Up to 1,100 post-market, consented patients will be treated with a MitraClip G4 device according to local guidelines and IFU from the Europe and Middle East, the United States, Canada and Japan, and will be included in the analysis for the MitraClip EXPAND G4 Study. Follow-up echocardiograms will be collected at Discharge, 30 days and 1 year and 5 year at post-procedure visits. Additional clinical follow-up visits will be at 6 months (phone call), 2, 3, 4 year (office visits). Cardiovascular adverse events will be reported through 5 years to confirm safety of the MitraClip G4 System.
During the Phase 1 of the study 100 subjects were enrolled at 15 sites in the United States with the goal of evaluating the early safety and procedural outcomes associated with the MitraClip G4. The follow up duration was 30 days. Phase I was completed August 2020.
Enrollment
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Volunteers
Inclusion criteria
- Subjects scheduled to receive the MitraClip per the current approved indications for use
- Subjects who give consent for their participation
Exclusion criteria
- Subjects participating in another clinical study that may impact the follow-up or results of this study
Trial design
1,164 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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