Ischemic Mitral RegurgitationENRAPTUSNCT04396379
Epicardial Mitral Touch System for Mitral Insufficiency
A study testing Implant an epicardial device to reshape the mitral valve annulus in people with Ischemic Mitral Regurgitation and Functional Mitral Regurgitation, run by Mitre Medical Corp. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Ischemic Mitral Regurgitation, Functional Mitral Regurgitation
- What is being tested?
- Implant an epicardial device to reshape the mitral valve annulus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Baylor Scott and White
Plano, Texas, 75093
Robert L. Smith, MD, 469-814-3278, robert.smith1@bswhealth.org
Robert L. Smith, MD
About this study
Official title: ENRAPTUS Epicardial Mitral Touch System for Mitral Insufficiency
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.
Read the 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.
- Being tested
- Implant an epicardial device to reshape the mitral valve annulus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant an epicardial device to reshape the mitral valve annulusDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Device Implantation | Experimental | 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. Receives: Device: Implant an epicardial device to reshape the mitral valve annulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Freedom from Major Adverse Events
Freedom from Major Adverse Events such as death, stroke, Increase of NYHA >1, Re-Hospitalization or reoperation of the Mitral Valve
Measured: Procedure through 30 days
Secondary outcomes (2)
Rate of Technical Feasibility to implant the Mitral Touch Device
Septal lateral diameter reduction of the mitral valve at implantation, Reduction in MR Grade by at least 1 grade from baseline
Measured: Procedure
Rate of Freedom from Serious Adverse Events from Implantation of the Mitral Touch Device
Implantation of the Mitral Touch Device without Serious Adverse Events
Measured: procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start10 Sep 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Mitral RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, single arm, un-blinded, multi-center early feasibility study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mitre Medical Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BSWRI Cardiac Imaging Core Lab (CICL)
- Responsible party
- Sponsor
- Investigators
- Robert L Smith II, MD, Principal investigator, Baylor Scott and White Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396379
- Sponsor's protocol ID
- TPL0002
- Acronym
- ENRAPTUS
- Status last verified
- Jan 2023
- First submitted
- 15 May 2020
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENRAPTUS Epicardial Mitral Touch System for Mitral Insufficiency
- ClinicalTrials.gov ID
- NCT04396379
- Acronym / sponsor ID
- ENRAPTUS / TPL0002
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mitre Medical Corp.Industry (pharma, biotech, devices)
- Collaborators
- BSWRI Cardiac Imaging Core Lab (CICL)
- Study start
- 10 Sep 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, single arm, un-blinded, multi-center early feasibility study
| Arm | Type | Receives |
|---|---|---|
| Device Implantation | Experimental | Device: Implant an epicardial device to reshape the mitral valve annulusTo 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implant an epicardial device to reshape the mitral valve annulusThe 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. | Device | Device Implantation |
Primary outcome
Rate of Freedom from Major Adverse Events
Time frame: Procedure through 30 days
Freedom from Major Adverse Events such as death, stroke, Increase of NYHA >1, Re-Hospitalization or reoperation of the Mitral Valve
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Ischemic Mitral Regurgitation
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Recruiting
Early Doppler-Assisted Mobilization in Adults After Acute Ischemic Stroke
Arterial Ischemic Stroke
Not yet recruitingObservational study
Impact of Stroke Unit Care on Acute Stroke Outcomes
Acute Stroke, Ischemic Stroke
Recruiting
Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock
Cardiogenic Shock, Mitral Regurgitation
Active, not recruiting
Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation
Mitral Regurgitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert L Smith II, MD principal investigator
Baylor Scott and White Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant an epicardial device to reshape the mitral valve annulus in people with Ischemic Mitral Regurgitation and Functional Mitral Regurgitation, run by Mitre Medical Corp. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John MacMahon ((408)-940-5587, jmacmahon@mitremedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Freedom from Major Adverse Events (time frame: Procedure through 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.