Observational Study of the Heart Repair Technologies Mitr... | NCT03511716

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

NCT03511716

Sponsor

Heart Repair Technologies, Inc.

Status

Terminated

Last Update Posted

Oct 8, 2020Actual

Enrollment

34Actual

Phase

Not provided

Conditions

Mitral Regurgitation

Interventions

HRT Mitral Bridge Mitral Valve Repair

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Could not enroll enough patients and ran out of $$ to manufacture more devices$$

Expanded Access Info

Start Date

Feb 6, 2014Actual

Primary Completion Date

Aug 2019Actual

Completion Date

Aug 31, 2019Actual

First Submitted Date

Apr 9, 2018

First Submission Date that Met QC Criteria

Apr 27, 2018

First Posted Date

Apr 30, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2020

Last Update Posted Date

Oct 8, 2020Actual

Name	Class
Na Homolce Hospital	OTHER

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Success	- Freedom from subsequent open mitral valve repair or replacement	One, 3, 6,12, 24, 36, 48, and 60 months

Secondary Outcomes

Measure	Description	Time Frame
Preservation or improvement of left ventricular remodeling	Change in Left Ventricular status	One, 3, 6,12, 24, 36, 48, and 60 months
Preservation of improvement in NYHA (New York Heart Association) functional class.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Name	Affiliation	Role
Štěpán ČERNÝ, MD, PhD, MBA	Cardiac Surgeon, Head of Hybrid Operating Room,	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Na Homolce Hospital		Prague	Homolka	5	Czechia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30590416	Derived	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.

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases