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Chordal Repair for Transcatheter Mitral Valve Repair (TMVr)

Primary Purpose

Degenerative Mitral Valve Disease, Mitral Valve Regurgitation

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Transcatheter implantation of chordal repair system
Sponsored by
Pipeline Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Mitral Valve Disease

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Presence of moderate to severe Mitral regurgitation as read on an echocardiographic study performed within 60 days prior to procedure. Estimated post-ePTFE chordae tendineae implantation coaptation surface is adequate in the judgment of the operating physician and the patient eligibility committee. Degenerative mitral valve disease. Patients who have been evaluated and no contraindication has been found for open heart surgery OR candidates for mitral valve surgery who, according to current guidelines, are at elevated surgical risk AND for whom transcatheter therapy is deemed more appropriate than open heart surgery in the judgement of the Site Heart Team. Exclusion Criteria: Untreated clinically significant coronary artery disease requiring revascularization Creatine Kinase-MB (CK-MB) obtained within prior 14 days > local laboratory Upper Limit of Normal (ULN) Age <30/40 or > 85 years Presence of any of the following: Estimated pulmonary artery systolic pressure (PASP) > 70 mmHg assessed by site based on echocardiography or right heart catheterization Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, ischemic or non-ischemic Functional mitral regurgitation or any other structural heart disease causing heart failure Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis) Hemodynamic instability requiring inotropic support or mechanical heart assistance Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction Left Ventricular Ejection Fraction (LVEF) is < 30% (within 90 days prior to subject enrollment, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI)) Mitral annular diameter >45mm in any dimension. Left Ventricular End Diastolic Diameter (LVEDD) > 65mm. Left Ventricular End Systolic Dimension (LVESD) > 55 mm assessed by site based on a transthoracic echocardiographic (TTE) obtained within 90 days prior to subject enrollment Coronary artery bypass grafting (CABG) within 30 days prior to subject's consent Percutaneous coronary intervention within 30 days prior to subject's consent Tricuspid valve disease requiring surgery Aortic valve disease requiring surgery or TAVI Carotid surgery within 30 days prior to subject's consent Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within the last 30 days prior to subject's consent Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure Status 1 heart transplant or prior orthotopic heart transplantation Chronic Kidney Disease with a baseline serum creatinine > 1.5mg/dL Chronic Steroid Therapy Cerebrovascular accident within 30 days prior to subject's consent Severe symptomatic carotid stenosis (> 70 % via ultrasound) Life expectancy < 12 months due to non-cardiac conditions Active infections requiring current antibiotic therapy Pregnant or planning pregnancy within next 12 months Currently participating in an investigational drug or another device study Severe organic lesions with mitral chords retraction, severely fibrotic and immobile leaflets, severely deformed subvalvular apparatus Evolving endocarditis or active endocarditis in the last 3 months Heavily calcified or dilated annulus or leaflets, mitral valve stenosis Congenital malformation with limited valvular tissue Patient requires mitral valve replacement Previously implanted prosthetic mitral valve or annuloplasty ring/band Evidence of LV or LA thrombus, vegetation or mass Severe tricuspid regurgitation or severe RV dysfunction Condition that prevents transfemoral access Anatomical ineligibility to the investigational device Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution, anticoagulation therapy) or hypersensitivity to nickel or titanium

Sites / Locations

  • Israeli-Georgian Medical Research Clinic Healthycore, LTD
  • Sanatorio Italiano
  • Institute for Cardiovascular Diseases Dedinje
  • Institute for Cardiovascular Diseases Vojvodina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Permanent Implant

Arm Description

Insertion of the Chordal Repair System tethering the mitral leaflets to the left ventricle.

Outcomes

Primary Outcome Measures

Safety at 30 days: freedom from death or intervention resulting from valve dysfunction or the implant procedure at 30 days.
Primary Safety
Freedom from device-related Major Adverse Events (MAE), defined as a combined clinical endpoint of death, reoperation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke or renal failure
Primary Safety
Technical successful transcatheter implantation of the Chordal Repair System tethering the mitral leaflets to the ventricle
Technical Success
Procedural success defined as the successful implant of the device resulting in MR severity of < moderate at 30 days as confirmed by echocardiography.
Procedural Success

Secondary Outcome Measures

Full Information

First Posted
February 20, 2020
Last Updated
August 28, 2023
Sponsor
Pipeline Medical
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1. Study Identification

Unique Protocol Identification Number
NCT04281940
Brief Title
Chordal Repair for Transcatheter Mitral Valve Repair (TMVr)
Official Title
Chordal Repair for Transcatheter Mitral Valve Repair (TMVr)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 18, 2022 (Actual)
Primary Completion Date
June 7, 2023 (Actual)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pipeline Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A multi-center evaluation of the Pipeline chordal repair system for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve repair.
Detailed Description
The proposed study is a prospective, multi-center, interventional investigation enrolling up to 30 subjects in multiple sites in Latin America and Eastern Europe. The primary objective of this study is to collect preliminary information on the performance and safety of the Pipeline Chordal Repair System in percutaneous reduction of significant mitral regurgitation (MR ≥ moderate) due to primary abnormality of the mitral apparatus [degenerative MR].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Mitral Valve Disease, Mitral Valve 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
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Permanent Implant
Arm Type
Experimental
Arm Description
Insertion of the Chordal Repair System tethering the mitral leaflets to the left ventricle.
Intervention Type
Device
Intervention Name(s)
Transcatheter implantation of chordal repair system
Intervention Description
Implantation of anchor via transcatheter delivery system to delivery chordal repair system tethering the mitral leaflets to the ventricle
Primary Outcome Measure Information:
Title
Safety at 30 days: freedom from death or intervention resulting from valve dysfunction or the implant procedure at 30 days.
Description
Primary Safety
Time Frame
Procedure through 30 days post procedure
Title
Freedom from device-related Major Adverse Events (MAE), defined as a combined clinical endpoint of death, reoperation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke or renal failure
Description
Primary Safety
Time Frame
Procedure through 30 days post procedure
Title
Technical successful transcatheter implantation of the Chordal Repair System tethering the mitral leaflets to the ventricle
Description
Technical Success
Time Frame
Procedure
Title
Procedural success defined as the successful implant of the device resulting in MR severity of < moderate at 30 days as confirmed by echocardiography.
Description
Procedural Success
Time Frame
Procedure through 30 days post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presence of moderate to severe Mitral regurgitation as read on an echocardiographic study performed within 60 days prior to procedure. Estimated post-ePTFE chordae tendineae implantation coaptation surface is adequate in the judgment of the operating physician and the patient eligibility committee. Degenerative mitral valve disease. Patients who have been evaluated and no contraindication has been found for open heart surgery OR candidates for mitral valve surgery who, according to current guidelines, are at elevated surgical risk AND for whom transcatheter therapy is deemed more appropriate than open heart surgery in the judgement of the Site Heart Team. Exclusion Criteria: Untreated clinically significant coronary artery disease requiring revascularization Creatine Kinase-MB (CK-MB) obtained within prior 14 days > local laboratory Upper Limit of Normal (ULN) Age <30/40 or > 85 years Presence of any of the following: Estimated pulmonary artery systolic pressure (PASP) > 70 mmHg assessed by site based on echocardiography or right heart catheterization Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, ischemic or non-ischemic Functional mitral regurgitation or any other structural heart disease causing heart failure Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis) Hemodynamic instability requiring inotropic support or mechanical heart assistance Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction Left Ventricular Ejection Fraction (LVEF) is < 30% (within 90 days prior to subject enrollment, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI)) Mitral annular diameter >45mm in any dimension. Left Ventricular End Diastolic Diameter (LVEDD) > 65mm. Left Ventricular End Systolic Dimension (LVESD) > 55 mm assessed by site based on a transthoracic echocardiographic (TTE) obtained within 90 days prior to subject enrollment Coronary artery bypass grafting (CABG) within 30 days prior to subject's consent Percutaneous coronary intervention within 30 days prior to subject's consent Tricuspid valve disease requiring surgery Aortic valve disease requiring surgery or TAVI Carotid surgery within 30 days prior to subject's consent Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within the last 30 days prior to subject's consent Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure Status 1 heart transplant or prior orthotopic heart transplantation Chronic Kidney Disease with a baseline serum creatinine > 1.5mg/dL Chronic Steroid Therapy Cerebrovascular accident within 30 days prior to subject's consent Severe symptomatic carotid stenosis (> 70 % via ultrasound) Life expectancy < 12 months due to non-cardiac conditions Active infections requiring current antibiotic therapy Pregnant or planning pregnancy within next 12 months Currently participating in an investigational drug or another device study Severe organic lesions with mitral chords retraction, severely fibrotic and immobile leaflets, severely deformed subvalvular apparatus Evolving endocarditis or active endocarditis in the last 3 months Heavily calcified or dilated annulus or leaflets, mitral valve stenosis Congenital malformation with limited valvular tissue Patient requires mitral valve replacement Previously implanted prosthetic mitral valve or annuloplasty ring/band Evidence of LV or LA thrombus, vegetation or mass Severe tricuspid regurgitation or severe RV dysfunction Condition that prevents transfemoral access Anatomical ineligibility to the investigational device Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution, anticoagulation therapy) or hypersensitivity to nickel or titanium
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Ebner, MD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Israeli-Georgian Medical Research Clinic Healthycore, LTD
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Sanatorio Italiano
City
Asunción
ZIP/Postal Code
1849
Country
Paraguay
Facility Name
Institute for Cardiovascular Diseases Dedinje
City
Belgrade
ZIP/Postal Code
11040
Country
Serbia
Facility Name
Institute for Cardiovascular Diseases Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia

12. IPD Sharing Statement

Plan to Share IPD
No

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Chordal Repair for Transcatheter Mitral Valve Repair (TMVr)

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