N/A
N=16
MitraClip Russia Trial
Functional Mitral Regurgitation · Degenerrative Mitral Regurgitation
Bottom Line
View on ClinicalTrials.gov: NCT04350372 ↗Enrolled (actual)
16
Serious AEs
12.5%
Results posted
Jun 2022
Primary outcome: Primary: Number of Patients With Successful Implantation of the MitraClip NT Device — 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MitraClip Procedure (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Successful Implantation of the MitraClip NT Device |
15 | — |
Summary
The MitraClip System is the first commercially available catheter-based option for the treatment of MR. The MitraClip System was developed as an alternate percutaneous technology which may serve as a viable therapeutic option for patients at high risk for open-heart surgery. Treatment with the MitraClip device allows patients to undergo a less invasive procedure that can mechanistically reduce MR and allow for improved quality of life. The MitraClip procedure is performed under general anesthesia without the use of a heart-lung machine, with recovery typically lasting two to three days.
The objective of this study is to evaluate safety and effectiveness of the MitraClip NT procedure in the Russian population for treatment of Mitral Regurgitation.
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older.
- Symptomatic moderate-to-severe (3+) or severe MR (4+) chronic DMR or FMR determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days or transesophageal echocardiogram (TEE) obtained within 180 days prior to subject registration.
- LVEF ≥ 30%
- NYHA classification is class II, class III, or ambulatory class IV.
- Subject is deemed difficult for mitral valve surgery due to either STS surgical mortality risk for mitral valve replacement of ≥ 8% OR due to the presence of one of the following risk factors (Porcelain aorta or mobile ascending aortic atheroma, Post-radiation mediastinum, Previous mediastinitis, Functional MR with LVEF<40%, Over 75 years old with LVEF<40%, Re-operation with patent grafts, Two or more prior cardiothoracic surgeries, Hepatic cirrhosis, Other surgical risk factor(s))
- Mitral valve area ≥ 4.0 cm2.
- The primary regurgitant jet is non-commisural, and in the opinion of the implanting investigator can successfully be treated by the MitraClip NT System. If a secondary jet exists, it must be considered clinically insignificant
Exclusion Criteria
- Subject is currently participating in another clinical investigation
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow up period
- Patients with the following conditions: Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen; Active endocarditis of the mitral valve; Rheumatic mitral valve disease; Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus.
- Contraindications for reusable accessories (stabilizer, lift, support plate)
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
Data sourced from ClinicalTrials.gov (NCT04350372). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.