- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03929913
NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study
This research protocol tests a new technique and devices that we have developed to treat functional mitral valve regurgitation, called transcatheter mitral valve cerclage annuloplasty, otherwise known as "cerclage". Functional mitral valve regurgitation is a condition caused by damaged heart muscle involving the left ventricle which results in mitral valve leakage. This leakage causes heart failure (breathlessness and lack of energy especially when walking or exercising, and hospital admissions for fluid buildup).
This is an early feasibility study (EFS) evaluation of special devices, permanently implanted in the heart, to perform mitral cerclage annuloplasty. Mitral cerclage annuloplasty is a catheter procedure performed under X-ray and ultrasound guidance without surgery. The cerclage devices compress the mitral valve like a purse-string. The cerclage device has a special feature that prevents a coronary artery from getting squeezed as part of this purse-string.
The protocol has been changed to allow patients who have mitral valve regurgitation despite prior Mitra-Clip treatment, and to allow patients who have symptomatic heart failure with mild mitral regurgitation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Medstar Washington Hospital Center
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Georgia
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Atlanta, Georgia, United States, 30322-1102
- Emory University
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Virginia
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Roanoke, Virginia, United States, 24014
- Carilion Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
INCLUSION CRITERIA:
- Adults age >=21 years
Symptomatic functional mitral valve regurgitation
- Mild or greater mitral valve regurgitation, LVEF <= 0.50, and NYHA class III - IV heart failure
- Moderate or greater mitral valve regurgitation and NYHA II - IV heart failure, irrespective of LV systolic function
- On optimal medical therapy for at least one month
- Left ventricular ejection fraction >=0.20 assessed by echocardiography, CT, or CMR
- Suitable coronary venous anatomy for Transcatheter Mitral Cerclage Annuloplasty based on pre-procedural cardiac CT or coronary venogram
- Concordance of the Study Eligibility Committee
- If present, a MitraClip was implanted at least 30 days previously
EXCLUSION CRITERIA:
- Subjects unable to consent to participate
- Subjects unwilling to participate or unwilling to return for study follow-up activities.
Prior cardiac implanted electronic devices (CIED) likely to be entrapped by cerclage.
-- Candidates with coronary sinus or left ventricular pacing or defibrillation leads that are not likely to be entrapped by cerclage, evident on baseline CT or angiogram, are eligible to participate.
- TAVR within 6 weeks
- Intended concurrent structural heart procedure, such as aortic or tricuspid valve intervention
- Aortic stenosis more than mild in severity
- Single-leaflet MitraClip detachment, if present
- Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
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 |
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Experimental: Transcatheter Mitral Valve Cerclage Annuloplasty
To evaluate the feasibility and safety of Transcatheter Mitral Cerclage Annuloplasty (TMCA) to treat symptomatic heart failure accompanied by mitral valve regurgitation despite optimal medical therapy. The TMCA implant is attached to a guidewire and pulled through the internal jugular sheath, along the coronary sinus, through the basal septum, through the tricuspid valve, and back out of the internal jugular sheath. The position of the TMCA implant is adjusted so that the coronary protection element lies directly over any underlying branch of the left coronary artery. |
The Transcatheter Mitral Cerclage Annuloplasty implant has two components, with or without a coronary artery protection element, and the wishbone lock with coronary sinus and right ventricular outflow track limbs.
Procedure is performed from a trans-jugular venous approach.
Coronary guidewires and microcatheters are used to navigate into a coronary vein to the target capture catheter.
The implant is then attached to the back end of the guidewire and pulled out of the internal jugular sheath.
The position of the implant is adjusted so the coronary protection element lies directly over any underlying branch of the left coronary artery.
The wishbone lock is advanced over the two limbs of the implant and the desired tension is titrated to the degree of mitral regurgitation.
Coronary angiography is performed to confirm there is no coronary compression.
After desired tension has been achieved, the wishbone lock is locked and the two limbs of the implant are cut with a cutter catheter.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Primary Endpoint is Technical Success
Time Frame: 1 minute following procedure discharge (Exit from the catheterization laboratory)
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The primary endpoint is Technical success. This endpoint is measured at exit from the catheterization laboratory. All of the following must be present:
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1 minute following procedure discharge (Exit from the catheterization laboratory)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Secondary Endpoint is Procedural Success
Time Frame: Day 30 post procedure
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The secondary endpoint is Procedural success This endpoint is measured at 30 days. All of the following must be present:
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Day 30 post procedure
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Collaborators and Investigators
Investigators
- Principal Investigator: Robert J Lederman, M.D., National Heart, Lung, and Blood Institute (NHLBI)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 190088
- 19-H-0088
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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