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

NCT03511716 | Terminated DMC

• 1 other identifier: HRT Mitral Bridge
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Regurgitation

Keywords

Mitral Insufficiency; Mitral Valve Incompetence

Outcome Measures

Primary Outcomes (1)

• Clinical Success

  \- Freedom from subsequent open mitral valve repair or replacement

  One, 3, 6,12, 24, 36, 48, and 60 months

Secondary Outcomes (2)

• Preservation or improvement of left ventricular remodeling

  One, 3, 6,12, 24, 36, 48, and 60 months

• Preservation of improvement in NYHA (New York Heart Association) functional class.

  One, 3, 6,12, 24, 36, 48, and 60 months

Interventions

HRT Mitral Bridge Mitral Valve Repair DEVICE

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heart Repair Technologies, Inc.: lead
• Na Homolce Hospital: collaborator

Study Sites (1)

Na Homolce Hospital

Prague, Homolka, 5, Czechia

Location

Related Publications (1)

• Cerny S, Benesova M, Skalsky I, Patel NC, Subramanian VA. Persistent reduction of mitral regurgitation by implantation of a transannular mitral bridge: durability and effectiveness of the repair at 2 years-results of a prospective trialdagger. Eur J Cardiothorac Surg. 2019 May 1;55(5):867-873. doi: 10.1093/ejcts/ezy423.

  PMID: 30590416 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Štěpán ČERNÝ, MD, PhD, MBA

  Cardiac Surgeon, Head of Hybrid Operating Room,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 30, 2018
• Study Start: February 6, 2014
• Primary Completion: August 1, 2019
• Study Completion: August 31, 2019
• Last Updated: October 8, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)