Chordal Repair for Transcatheter Mitral Valve Repair (TMVr)

NCT04281940 | Completed DMC

• 1 other identifier: CIP-0001
• Study Type: interventional
• Target: 7
• Locations: 3 countries
• Sites: 4

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.

Conditions

Degenerative Mitral Valve Disease; Mitral Valve Regurgitation

Outcome Measures

Primary Outcomes (4)

• Safety at 30 days: freedom from death or intervention resulting from valve dysfunction or the implant procedure at 30 days.

  Primary Safety

  Procedure through 30 days post procedure

• 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

  Procedure through 30 days post procedure

• Technical successful transcatheter implantation of the Chordal Repair System tethering the mitral leaflets to the ventricle

  Technical Success

  Procedure

• 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

  Procedure through 30 days post procedure

Study Arms (1)

Permanent Implant

EXPERIMENTAL

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

Device: Transcatheter implantation of chordal repair system

Interventions

Transcatheter implantation of chordal repair system DEVICE

Implantation of anchor via transcatheter delivery system to delivery chordal repair system tethering the mitral leaflets to the ventricle

Permanent Implant

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pipeline Medical: lead

Study Sites (4)

Israeli-Georgian Medical Research Clinic Healthycore, LTD

Tbilisi, 0112, Georgia

Location

Sanatorio Italiano

Asunción, 1849, Paraguay

Location

Institute for Cardiovascular Diseases Dedinje

Belgrade, 11040, Serbia

Location

Institute for Cardiovascular Diseases Vojvodina

Kamenitz, 21204, Serbia

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Adrian Ebner, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 24, 2020
• Study Start: March 18, 2022
• Primary Completion: June 7, 2023
• Study Completion: May 1, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2); GE (1); PA (1)