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Observational Study of the Heart Repair Technologies Mitral Bridge in Treating Mitral Valve Regurgitation (HRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03511716
Recruitment Status : Active, not recruiting
First Posted : April 30, 2018
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Na Homolce Hospital
Information provided by (Responsible Party):
Heart Repair Technologies, Inc.

Brief Summary:
Prospective, observational, multi-center trial in which patients with mitral regurgitation sufficient to merit mitral valve repair will receive a surgical transvalvular, intra-annular Mitral Bridge™ to reduce or eliminate mitral regurgitation.

Condition or disease Intervention/treatment
Mitral Regurgitation Device: HRT Mitral Bridge Mitral Valve Repair

Detailed Description:

The primary objective of this study is to evaluate the safety and performance of the Mitral Bridge device in the correction of mitral valve regurgitation in patients who qualify for mitral valve repair as defined by the American Society of Echocardiography (ASE). The device is a single use, mitral valve implant designed to reduce mitral regurgitation by reducing the septo-lateral mitral annular diameter, promoting early coaptation of the valve leaflets and restraining the leaflets below the intra-annular plane.

The protocol was designed as a First In Man (FIM) with a 6-month follow up but was amended to follow the enrolled patients for a total of 5 years.


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Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HRT Observational Study of a Mitral Bridge in Patients With Moderate to Severe Mitral Valve Regurgitation to Evaluate Device Safety and Performance
Actual Study Start Date : February 6, 2014
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 31, 2020

Intervention Details:
  • Device: HRT Mitral Bridge Mitral Valve Repair
    Surgical mitral valve implant intended to reduce mitral regurgitation by direct reduction of the septo-lateral mitral annular diameter, promoting early coaptation of the valve leaflets and restraining the leaflets below the intra-annular plane


Primary Outcome Measures :
  1. Clinical Success [ Time Frame: One, 3, 6,12, 24, 36, 48, and 60 months ]
    - Freedom from subsequent open mitral valve repair or replacement


Secondary Outcome Measures :
  1. Preservation or improvement of left ventricular remodeling [ Time Frame: One, 3, 6,12, 24, 36, 48, and 60 months ]
    Change in Left Ventricular status

  2. Preservation of improvement in NYHA (New York Heart Association) functional class. [ Time Frame: One, 3, 6,12, 24, 36, 48, and 60 months ]
    Change in NYHA (New York Heart Association) functional class.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients over the age of 21 with moderate to severe, functional (ischemic or dilated cardiomyopathies) mitral regurgitation or mitral regurgitation caused by dilation of the mitral annulus who qualify for mitral valve repair
Criteria

Inclusion Criteria:

  • Patients moderate to severe, symptomatic functional (ischemic or dilated cardiomyopathies) mitral regurgitation or mitral regurgitation caused by dilation of the mitral annulus who qualify for mitral valve repair with cardiopulmonary bypass
  • Mitral regurgitation must meet the following criteria:
  • The primary regurgitant jet is central, originating from mal coaptation of anterior and posterior leaflets of the mitral valve.
  • If a secondary jet is present, the jet must be considered clinically insignificant.
  • Women of child-bearing potential have a negative pregnancy test

Exclusion Criteria:

  • Evidence of severe mitral annular and leaflet calcification.
  • Patient is hemodynamically unstable.
  • Patient has hypertrophic cardiomyopathy and has systolic anterior motion of the leaflets.
  • Patient requires emergency surgery.
  • Patient has echocardiographic evidence of endocarditis or rheumatic heart disease.
  • Transesophageal Echocardiogram (TEE) is contraindicated or cannot be performed intraoperatively for any reason.
  • Patient has known chronic, dialysis-dependent renal failure.
  • History of stroke, transient ischemic attack (TIA) or reversible ischemic neurological disease within the last three (3) months.
  • History of gastrointestinal bleeding within the last three (3) months.
  • History of hypersensitivity or allergy to aspirin
  • History or hypersensitivity to clopidogrel (Plavix) or its congeners.
  • Active or treated malignancies in the last twelve (12) months.
  • Patient is participating in another clinical study for which follow-up is currently ongoing.
  • Women of child-bearing age who have not had a negative pregnancy test.
  • Patient with non-cardiac co-morbidities and life expectancy < 1 year.
  • Patient has a condition that, in the opinion of the Investigator, precludes participation, including willingness to comply with all follow-up procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511716


Locations
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Czechia
Na Homolce Hospital
Prague, Homolka, Czechia, 5
Sponsors and Collaborators
Heart Repair Technologies, Inc.
Na Homolce Hospital
Investigators
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Principal Investigator: Štěpán ČERNÝ, MD, PhD, MBA Cardiac Surgeon, Head of Hybrid Operating Room,

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Heart Repair Technologies, Inc.
ClinicalTrials.gov Identifier: NCT03511716     History of Changes
Other Study ID Numbers: HRT Mitral Bridge
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heart Repair Technologies, Inc.:
Mitral Insufficiency
Mitral Valve Incompetence
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases