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NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study

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ClinicalTrials.gov Identifier: NCT03929913
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : March 16, 2020
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:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study
Actual Study Start Date : May 7, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Arm Intervention/treatment
Experimental: Study Arm # 2
Cerclage WITH prior Mitra-Clip repair: The procedure is unchanged in the presence of prior Mitra-Clip.
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.

Experimental: Study Arm #1
Cerclage WITHOUT prior Mitra-Clip repair: 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 classified 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.


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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

      ADDITIONAL INCLUSION FOR MITRA-CLIP ARM:

    8. Predominantly functional mitral regurgitation as indication for Mitra-Clip
    9. At least 30 days after Mitra-Clip implantation, and at least 24 months after Mitra-Clip implantation if enrolled in COAPT trial

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

    ADDITIONAL EXCLUSION FOR MITRA-CLIP ARM:

  9. Single-leaflet detachment of Mitra-Clip

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
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Contact: Annette Stine, R.N. (301) 402-5558 stinea@nhlbi.nih.gov

Locations
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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, 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
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Principal Investigator: Robert J Lederman, M.D. National Heart, Lung, and Blood Institute (NHLBI)
Additional Information:
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Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT03929913    
Other Study ID Numbers: 190088
19-H-0088
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 9, 2020

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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:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases