search
Back to results

NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study

Primary Purpose

Functional Mitral Regurgitation

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transmural Systems Transcatheter Mitral Cerclage Annuloplasty (TMCA)
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Mitral Regurgitation focused on measuring Ventricular Dysfunction, Functional Mitral Regurgitation, Heart Failure, Mitral Implant, Secondary Mitral Regurgitation

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

  • 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

Sites / Locations

  • MedStar Washington Hospital Center
  • Emory University
  • Carilion Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcatheter Mitral Valve Cerclage Annuloplasty

Arm Description

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.

Outcomes

Primary Outcome Measures

The Primary Endpoint is Technical Success
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 Cerclage 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 delivery system.

Secondary Outcome Measures

The Secondary Endpoint is Procedural Success
The secondary endpoint is Procedural success This endpoint is measured at 30 days. All of the following must be present: Technical success No Transcatheter Mitral Cerclage Annuloplasty (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.

Full Information

First Posted
April 26, 2019
Last Updated
July 24, 2023
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT03929913
Brief Title
NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study
Official Title
NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 7, 2019 (Actual)
Primary Completion Date
February 23, 2021 (Actual)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Mitral Regurgitation
Keywords
Ventricular Dysfunction, Functional Mitral Regurgitation, Heart Failure, Mitral Implant, Secondary Mitral Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcatheter Mitral Valve Cerclage Annuloplasty
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transmural Systems Transcatheter Mitral Cerclage Annuloplasty (TMCA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Primary Endpoint is Technical Success
Description
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 Cerclage 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 delivery system.
Time Frame
1 minute following procedure discharge (Exit from the catheterization laboratory)
Secondary Outcome Measure Information:
Title
The Secondary Endpoint is Procedural Success
Description
The secondary endpoint is Procedural success This endpoint is measured at 30 days. All of the following must be present: Technical success No Transcatheter Mitral Cerclage Annuloplasty (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.
Time Frame
Day 30 post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Lederman, M.D.
Organizational Affiliation
National Heart, Lung, and Blood Institute (NHLBI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1102
Country
United States
Facility Name
Carilion Medical Center
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The authors are willing to share de-identified subject data upon reasonable request.
Links:
URL
https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2019-H-0088.html
Description
NIH Clinical Center Detailed Web Page

Learn more about this trial

NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study

We'll reach out to this number within 24 hrs