## Protocol Section
### Identification Module
**NCT ID:** NCT04396379

**Acronym:** ENRAPTUS

**Brief Title:** Epicardial Mitral Touch System for Mitral Insufficiency

**Official Title:** ENRAPTUS Epicardial Mitral Touch System for Mitral Insufficiency

#### Organization Study ID Info
**ID:** TPL0002
#### Organization
**Class:** INDUSTRY
**Full Name:** Mitre Medical Corp.
### Status Module
#### Completion Date
**Date:** 2027-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-01-04

**Type:** ACTUAL

**Last Update Submit Date:** 2023-01-02

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-09-10

**Type:** ESTIMATED

**Status Verified Date:** 2023-01

#### Study First Post Date
**Date:** 2020-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2020-05-15
**Study First Submit QC Date:** 2020-05-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** BSWRI Cardiac Imaging Core Lab (CICL)

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Mitre Medical Corp.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is Unapproved Device:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Ischemic Mitral Regurgitation

- Functional Mitral Regurgitation

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** prospective, single arm, un-blinded, multi-center early feasibility study

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DEVICE_FEASIBILITY

#### Enrollment Info

**Count:** 10

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** To epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy) using an epicardial implant.

**Intervention Names:**

- Device: Implant an epicardial device to reshape the mitral valve annulus

**Label:** Device Implantation

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Device Implantation

**Description:** 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.

**Name:** Implant an epicardial device to reshape the mitral valve annulus

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Freedom from Major Adverse Events such as death, stroke, Increase of NYHA \>1, Re-Hospitalization or reoperation of the Mitral Valve

**Measure:** Rate of Freedom from Major Adverse Events

**Time Frame:** Procedure through 30 days

#### Secondary Outcomes

**Description:** Septal lateral diameter reduction of the mitral valve at implantation, Reduction in MR Grade by at least 1 grade from baseline

**Measure:** Rate of Technical Feasibility to implant the Mitral Touch Device

**Time Frame:** Procedure

**Description:** Implantation of the Mitral Touch Device without Serious Adverse Events

**Measure:** Rate of Freedom from Serious Adverse Events from Implantation of the Mitral Touch Device

**Time Frame:** procedure

### Eligibility Module

**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.)

**Minimum Age:** 22 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jmacmahon@mitremedical.com

**Name:** John MacMahon

**Phone:** (408)-940-5587

**Role:** CONTACT

**Contact 2:**

**Email:** laura22@mmc-medical.com

**Name:** Laura A Minarsch

**Phone:** (949)2805700

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Plano

**Contacts:**

***Contact 1:***

- **Email:** robert.smith1@bswhealth.org

- **Name:** Robert L. Smith, MD

- **Phone:** 469-814-3278

- **Role:** CONTACT

***Contact 2:***

- **Name:** Robert L. Smith, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Baylor Scott and White

**State:** Texas

**Zip:** 75093

#### Overall Officials

**Official 1:**

**Affiliation:** Baylor Scott and White Medical Center

**Name:** Robert L Smith II, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006349

- Term: Heart Valve Diseases

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M11910

- Name: Mitral Valve Insufficiency

- Relevance: HIGH

- As Found: Mitral Regurgitation

- ID: M9437

- Name: Heart Valve Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008944

- Term: Mitral Valve Insufficiency

### Misc Info Module

- Version Holder: 2024-05-24
