Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03929913
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Functional Mitral Regurgitation Device: Transmural Systems Transcatheter Mitral Cerclage Annuloplasty(TMCA) Not Applicable

Detailed Description:

Functional mitral regurgitation (also known as secondary mitral regurgitation) is a common

complication of left ventricular dysfunction. Ventricular dysfunction leads to dilation, which in

turn leads to mitral annular dilation and leaflet traction. This causes a failure of coaptation of

the otherwise intact leaflets of the mitral valve, leading to regurgitation through a central

orifice between the mal-coapting leaflet tips. Functional mitral regurgitation contributes to heart failure symptoms.Transcatheter Mitral Cerclage Annuloplasty (TMCA) is a new catheter technique that reduces the septal-lateral dimension of the dilated annulus through circumferential compression, prevents extrinsic compression and entrapment of coronary arteries by incorporating a protection element, and exhibits planar discordance that achieves annular reduction even when the coronary sinus is anatomically located along the posterior left atrial wall. This is an entirely right-sided procedure and device.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study
Estimated Study Start Date : August 21, 2019
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : December 31, 2024

Arm Intervention/treatment
Experimental: Study Arm #1
The Transcatheter Mitral Cerclage Annuloplasty implant is attached to a guidewire and pulled through the internal jugular sheath, along the coronary sinus, through the basal septum, through the tricuspidvalve, 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 branc of the left coronary artery.
Device: Transmural Systems Transcatheter Mitral Cerclage Annuloplasty(TMCA)
The Transcatheter Mitral Cerclage Annuloplasty implant comprises two components, with or without a coronary artery protection element, and the wishbone lock with coronary sinus and RVOT limbs. The procedure is performed from a transjugular venous approach. Coronary guidewires and microcatheters are used to navigate into a coronary vein towards 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 that the coronary protection element lies directly over any underlying branch of the left coronary artery. The wishbone lock is then 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. Once the desired tension has been achieved, the wishbone lock is locked and the two limbs of the implant are cut with a cutter catheter.




Primary Outcome Measures :
  1. The primary endpoint is technical success measured at exit from the catheterization laboratory. [ Time Frame: Exit from the catheterization laboratory ]
    The primary endpoint is Technical success. This endpoint is measured at exit from the catheterization laboratory. All of the following must be present:-Alive-Successful deployment and correct positioning of a single intended Transcatheter Mitral Cer-clage Annuloplasty (TMCA). Repositioning and recapture of the device, if needed, is not classi-fied as failure.-Retrieval of the TMCA delivery system-Absence of TMCA-related coronary artery compression and absence of additional procedure such as percutaneous coronary intervention (PCI) to relieve coronary artery compression-No additional unplanned or emergency surgery or re- intervention related to the TMCA or de-livery system


Secondary Outcome Measures :
  1. The secondary endpoint is Procedural success [ Time Frame: Measured at 30 day post procedure ]
    The secondary endpoint is Procedural success This endpoint is measured at 30 days. All of the following must be present-Technical success-No TMCA device-related Serious Adverse Events, defined as VARC-2 life- threatening bleeding, major vascular or cardiac complications related to the TMCA requiring unplanned reinterven-tion or surgery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. Adults age greater than or equal to 21 years
    2. Severe functional mitral valve regurgitation defined as:

      • Effective orifice area greater than or equal to 20mm^2, AND
      • Regurgitant volume greater than or equal to 30mL/beat
    3. On optimal medical therapy for at least one month
    4. NYHA class II, III or IV heart failure symptoms
    5. Left ventricular ejection fraction greater than or equal to 0.20 assessed by echocardiography, CT, or CMR
    6. Suitable coronary venous anatomy for Transcatheter Mitral Cerclage Annuloplasty based on preprocedural cardiac CT
    7. Concordance of the study eligibility committee

EXCLUSION CRITERIA:

  1. Subjects unable to consent to participate
  2. Subjects unwilling to participate or unwilling to return for study follow-up activities.
  3. TAVR within 6 weeks
  4. Prior cardiac implanted electronic devices (CIED) likely to be entrapped by cerclage: Cardiac Resynchronization Therapy (CRT) with coronary sinus lead; Implantable Cardioverter Defibrillator

    (ICD) with lead likely to be entrapped based on corelab assessment of baseline CT; or, Single- or dual-chamber pacemaker with lead likely to be entrapped based on corelab assessment of baseline CT

  5. Prior Cardiac Resynchronization Therapy (CRT) with biventricular pacemaker/Implantable Cardioverter Defibrillator (ICD) and coronary sinus lead
  6. Intended concurrent structural heart procedure, such as aortic or tricuspid valve intervention
  7. Aortic stenosis more than mild in severity
  8. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929913


Contacts
Layout table for location contacts
Contact: Annette Stine, R.N. (301) 402-5558 stinea@nhlbi.nih.gov

Locations
Layout table for location information
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Toby Rogers, Ph. D.    202-877-5975    toby.rogers@medstar.net   
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322-1102
Contact: Adam B Greenbaum, M.D.    678-557-4514    adam.b.greenbaum@emory.edu   
Contact: Vasilis Babaliaros, M.D.    (678) 557-4514    vbabali@emory.edu   
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
United States, Virginia
Carilion Medical Center Recruiting
Roanoke, Virginia, United States, 24014
Contact: Jason Foerst, M.D.    540-632-9220    jrfoerst@carilionclinic.org   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
Principal Investigator: Robert J Lederman, M.D. National Heart, Lung, and Blood Institute (NHLBI)

Additional Information:
Layout table for additonal information
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT03929913     History of Changes
Other Study ID Numbers: 190088
19-H-0088
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 7, 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Ventricular Dysfunction
Functional Mitral Regurgitation
Heart Failure
Mitral Implant
Secondary Mitral Regurgitation

Additional relevant MeSH terms:
Layout table for MeSH terms
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases