Purpose

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

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Adults age greater than or equal to 21 years
  2. Severe functional mitral valve regurgitation defined as:
  3. Effective orifice area greater than or equal to 20mm^2, AND
  4. Regurgitant volume greater than or equal to 30mL/beat
  5. On optimal medical therapy for at least one month
  6. NYHA class II, III or IV heart failure symptoms
  7. Left ventricular ejection fraction greater than or equal to 0.20 assessed by echocardiography, CT, or CMR
  8. Suitable coronary venous anatomy for Transcatheter Mitral Cerclage Annuloplasty based on preprocedural cardiac CT
  9. 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

MedStar Washington Hospital Center
Washington, District of Columbia 20010
Contact:
Toby Rogers, Ph. D.
202-877-5975
toby.rogers@medstar.net

More Details

NCT ID
NCT03929913
Status
Recruiting
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)

Study Contact

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

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 likea 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.