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出境医 / 临床实验 / NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study

NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study

Study Description
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.

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....


Condition or disease Intervention/treatment Phase
Functional Mitral Regurgitation and Symptomatic Heart Failure 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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group 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 : January 30, 2022
Estimated Study Completion Date : December 31, 2026
Arms and Interventions
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 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.
 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.
Outcome Measures
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 reintervention or surgery


Eligibility Criteria
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 >=21 years

    2. Symptomatic functional mitral valve regurgitation

      1. Mild or greater mitral valve regurgitation, LVEF <= 0.50, and NYHA class III - IV heart failure
      2. Moderate or greater mitral valve regurgitation and NYHA II - IV heart failure, irrespective of LV systolic function
    3. On optimal medical therapy for at least one month
    4. Left ventricular ejection fraction >=0.20 assessed by echocardiography, CT, or CMR
    5. Suitable coronary venous anatomy for Transcatheter Mitral Cerclage Annuloplasty based on pre-procedural cardiac CT or coronary venogram
    6. Concordance of the Study Eligibility Committee
    7. If present, a MitraClip was implanted at least 30 days previously

EXCLUSION CRITERIA:

  1. Subjects unable to consent to participate
  2. Subjects unwilling to participate or unwilling to return for study follow-up activities.

  3. 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.

  4. TAVR within 6 weeks
  5. Intended concurrent structural heart procedure, such as aortic or tricuspid valve intervention
  6. Aortic stenosis more than mild in severity
  7. Single-leaflet MitraClip detachment, if present
  8. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
Contacts and Locations

Locations
Layout table for location information
United States, District of Columbia
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322-1102
United States, Virginia
Carilion Medical Center
Roanoke, Virginia, United States, 24014
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)
Tracking Information
First Submitted Date  ICMJE April 26, 2019
First Posted Date  ICMJE April 29, 2019
Last Update Posted Date March 10, 2021
Actual Study Start Date  ICMJE May 7, 2019
Estimated Primary Completion Date January 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2019) 		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
Original Primary Outcome Measures  ICMJE
 (submitted: April 26, 2019) 		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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2020) 		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 reintervention or surgery
Original Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2019) 		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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study
Official Title  ICMJE NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study
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.

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....
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Functional Mitral Regurgitation and Symptomatic Heart Failure
Intervention  ICMJE 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.
Study Arms  ICMJE 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 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.
Intervention: Device: Transmural Systems Transcatheter Mitral Cerclage Annuloplasty(TMCA)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Actual Enrollment  ICMJE
 (submitted: March 9, 2021) 		18
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2019) 		30
Estimated Study Completion Date  ICMJE December 31, 2026
Estimated Primary Completion Date January 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

  • INCLUSION CRITERIA:

    1. Adults age >=21 years

    2. Symptomatic functional mitral valve regurgitation

      1. Mild or greater mitral valve regurgitation, LVEF <= 0.50, and NYHA class III - IV heart failure
      2. Moderate or greater mitral valve regurgitation and NYHA II - IV heart failure, irrespective of LV systolic function
    3. On optimal medical therapy for at least one month
    4. Left ventricular ejection fraction >=0.20 assessed by echocardiography, CT, or CMR
    5. Suitable coronary venous anatomy for Transcatheter Mitral Cerclage Annuloplasty based on pre-procedural cardiac CT or coronary venogram
    6. Concordance of the Study Eligibility Committee
    7. If present, a MitraClip was implanted at least 30 days previously

EXCLUSION CRITERIA:

  1. Subjects unable to consent to participate
  2. Subjects unwilling to participate or unwilling to return for study follow-up activities.

  3. 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.

  4. TAVR within 6 weeks
  5. Intended concurrent structural heart procedure, such as aortic or tricuspid valve intervention
  6. Aortic stenosis more than mild in severity
  7. Single-leaflet MitraClip detachment, if present
  8. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03929913
Other Study ID Numbers  ICMJE 190088
19-H-0088
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert J Lederman, M.D. National Heart, Lung, and Blood Institute (NHLBI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date March 4, 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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