- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04350372
MitraClip Russia Trial
The MitraClip Russia Trial: A Prospective, Single-Center, Single-Arm Clinical Evaluation of the MitraClip System for the Treatment of Mitral Regurgitation
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Mitral regurgitation (MR) is the most common heart valve condition in the world. MR occurs when the mitral valve does not close properly, allowing blood to leak back into the upper chamber of the heart. As a result, the heart may try to pump harder in order to compensate for the decrease in blood flow to the rest of the body. Patients with severe MR suffer from debilitating symptoms such as shortness of breath, heart palpitations, lightheadedness, and fatigue. These patients are at risk of poor quality of life, marked limitation in activity, repeated heart failure hospitalizations, and increased mortality. Chronic severe MR is often associated with heart failure and can lead to death if left untreated.
While mitral valve repair or replacement surgery is currently regarded as standard of care, many patients with clinically significant MR are at an unacceptable risk of morbidity and mortality and are therefore not appropriate surgical candidates. To optimize afterload reduction and treatment of fluid load, these patients are often treated with medical management (i.e., beta blockers, ACE inhibitors, angiotensin II receptor blockers) which may relieve MR symptoms, but does not address the underlying cause of the condition. As a result, a significant portion of patients treated medically continue to progress to heart failure and experience an increasingly debilitating quality of life. A significant unmet clinical need thus exists for the treatment of moderate-to-severe and severe MR in high surgical risk patients.
The MitraClip System has been in clinical use for treatment of significant MR since 2003. The device received CE (Conformité Européenne) Mark for both DMR and FMR indications in March 2008 and was approved by FDA for DMR indication in October 2013 and for FMR indication in March 2019. The system is approved for use in more than 80 countries or regions. More than 80,000 patients have undergone the MitraClip procedure worldwide, with the majority of experience in high surgical risk patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Moscow, Russian Federation
- FSBI "NICC of Cardiology" of the Ministry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MitraClip
Subject will receive MitraClip procedure with MitraClip NT System
|
MitraClip procedure with MitraClip NT System
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With Successful Implantation of the MitraClip NT Device
Time Frame: 30-day
|
Successful implantation of the MitraClip NT device resulting in a decrease in the MR severity grade as assessed from the discharge echocardiogram (10-day echocardiogram will be used if discharge is unavailable or uninterpretable).
Subjects who die or undergo mitral valve surgery before discharge will be considered a failure for the procedure
|
30-day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABT-CIP 10334
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Functional Mitral Regurgitation
-
Ancora Heart, Inc.CompletedMitral Regurgitation | Mitral Valve Regurgitation | Functional Mitral RegurgitationAustria, Lithuania, Germany
-
Heinrich-Heine University, DuesseldorfCompletedMitral Regurgitation | Functional Mitral Regurgitation | Degenerative Mitral Valve RegurgitationGermany
-
Cardiac Dimensions Pty LtdTerminatedAtrial Fibrillation | Functional Mitral Regurgitation | Atrial Functional Mitral RegurgitationAustralia, Greece
-
Mitre Medical Corp.BSWRI Cardiac Imaging Core Lab (CICL)Not yet recruitingIschemic Mitral Regurgitation | Functional Mitral RegurgitationUnited States
-
Mardil MedicalRecruitingFunctional Mitral RegurgitationCanada, Hungary, France, Germany, Netherlands, Panama, Poland
-
Shanghai Shenqi Medical Technology Co., LtdActive, not recruitingFunctional Mitral RegurgitationChina
-
Jenscare ScientificEnrolling by invitationFunctional Mitral RegurgitationChina
-
Asklepios proresearchAbbottWithdrawn
-
Barts & The London NHS TrustRecruitingAtrial Fibrillation | Functional Mitral Regurgitation | Functional Tricuspid RegurgitationUnited Kingdom
-
Fuwai Yunnan Cardiovascular HospitalNot yet recruitingFunctional Mitral Regurgitation
Clinical Trials on MitraClip Procedure
-
Queen's UniversityAFP Innovation FundRecruiting
-
Abbott Medical DevicesCompletedMitral Regurgitation | Mitral Valve Insufficiency | Mitral Valve Regurgitation | Mitral Valve Incompetence | Mitral InsufficiencyUnited States
-
Population Health Research InstituteCompletedMitral RegurgitationCanada
-
Abbott Medical DevicesActive, not recruitingHeart Failure | Mitral Regurgitation | Mitral Valve Regurgitation | Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure SubjectsUnited States, Canada
-
Nantes University HospitalAbbott; Ministère de la SantéRecruiting
-
Abbott Medical DevicesAbbottTerminated
-
Azienda Socio Sanitaria Territoriale degli Spedali...RecruitingHeart Failure | Mitral RegurgitationItaly
-
Fundación Investigación Sanitaria en LeónAbbott Medical DevicesCompletedMitral Regurgitation | Acute Myocardial Infarction