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Not yet recruiting NCT04396379

Epicardial Mitral Touch System for Mitral Insufficiency

No phase Interventional Ischemic Mitral Regurgitation Functional Mitral Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Implant an epicardial device to reshape the mitral valve annulus.
Who it may be relevant to
Registry conditions: Ischemic Mitral Regurgitation, Functional Mitral Regurgitation. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

ENRAPTUS Epicardial Mitral Touch System for Mitral Insufficiency

Overview

To evaluate the safety and performance of the Mitral Touch System to treat mitral insufficiency in patients who are to undergo cardiac surgery with either a sternotomy or thoracotomy who present with moderate to severe ischemic or functional mitral regurgitation.

Detailed description

The Mitral Touch Systems is intended to epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy), in patients with left ventricular dilation and mitral valve insufficiency in patients with ischemic or functional MR.

Interventions

  • Device Implant an epicardial device to reshape the mitral valve annulus
    The implant is intended to epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy), in patients with left ventricular dilation and mitral valve insufficiency in patients with ischemic or functional MR.

Primary outcome measures

  • Rate of Freedom from Major Adverse Events [Time frame: Procedure through 30 days]
Secondary outcome measures (2)
  • Rate of Technical Feasibility to implant the Mitral Touch Device [Time frame: Procedure]
  • Rate of Freedom from Serious Adverse Events from Implantation of the Mitral Touch Device [Time frame: procedure]

Eligibility criteria

Inclusion criteria

  • Moderate or greater (2+) ischemic
  • Functional Mitral regurgitation by 2D echocardiography using an integrative method
  • Patient is scheduled for cardiac surgery (e.g. CABG including patients on the waiting list for Heart Transplantation)
  • Patient is 22 years of age or older
  • Patient is willing and able to sign Informed Consent Form
  • Within 90 days patients should be on stable optimally uptitrated medical therapy recommended according to current guidelines23 as standard of care for heart failure therapy in the United States

Exclusion criteria

  • Any evidence of structural (chordal or leaflet) mitral valve disease
  • Inability to derive ERO, LVESVI or LVEDVI by TTE
  • Prior surgical or percutaneous mitral valve intervention
  • Contraindication to cardiopulmonary bypass (CPB)
  • Clinical signs of cardiogenic shock
  • Treatment with chronic intravenous inotropic therapy
  • Severe, irreversible pulmonary hypertension in the judgement of the investigator
  • ST segment elevation requiring intervention within 7 days prior to randomization
  • Congenital heart disease (except PFO or ASD)
  • Evidence of cirrhosis or hepatic synthetic failure
  • Renal insufficiency (eGFR < 30 ml/min)
  • History of endocarditis or current endocarditis
  • Ejection fraction <25%
  • NY heart class IV
  • MV diameters > 7cm
  • Any coronary artery calcification at site of placement as determined by angiogram
  • Myxomatous mitral regurgitation
  • Women who are pregnant (by history of menstrual period or pregnancy test if history is considered unreliable)
  • Abnormal cardiac anatomy discovered prior to surgery or during procedure
  • Pericardial adhesions
  • Insufficient clinical signature reduction of mitral regurgitation during device sizing and placement. (No device remains, patient moved to only 30-Day follow-up.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

United States · 1 center
  • Baylor Scott and White — Plano

Identifiers

NCT: NCT04396379 · TPL0002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗