Heart FailureNCT04475315
Ventricular Sling for Heart Failure With Reduced Ejection Fraction
A study testing Papillary Muscle Sling and CABG surgery in people with Heart Failure and Cardiomyopathy, Dilated, run by University of Miami.
Trial summary
The purpose of this research is to investigate the effect of using this surgical technique in conjunction with bypass surgery to improve heart function and size, as well as decrease the possibility of future mitral valve surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiomyopathy, Dilated
- What is being tested?
- Papillary Muscle Sling and CABG surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 12 Dec 2021to Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic heart failure with reduced ejection fraction and either ischemic or non-ischemic cardiomyopathies, referred for CABG surgery. Suitability for the ventricular sling procedure is determined by the surgeon and or cardiologist, using some or all the criteria described below:
- Left ventricular end diastolic diameter is greater than or equal to 55mm.
- Ejection fraction ≥20% and ≤40%
- FMR grade ≤ 2+ (≤ mild FMR) as defined by the guidelines of the American society of echocardiography at the time of the study approval (via a transthoracic or transesophageal echo).
- End-systolic Interpapillary muscle distance ≥ 20mm
- Cardiomyopathy of ischemic or non-ischemic origins.
- Able to sign informed consent and release of medical information forms, or able to assign a legal representative who can sign on the patient's behalf.
Who cannot join
- Any evidence of structural (chordal or leaflet) mitral lesions.
- Planned concomitant intra-operative procedures (except for closure of patent foramen ovale or atrial septal defect or coronary revascularization)
- Planned concomitant intra-operative Maze procedure for symptomatic paroxysmal atrial fibrillation.
- Persistent atrial fibrillation
- Prior mitral valve repair
- Contraindication for cardiopulmonary bypass
Show all 12Show fewer
- Clinical signs of cardiogenic shock
- ST segment elevation myocardial infarction within 14 days prior to inclusion in this study.
- Congenital heart disease (except PFO or ASD)
- Chronic renal insufficiency defined by Creatinine ≥ 3.0 or chronic renal replacement therapy, who are contraindicated for cardiac surgery
- Recent history of psychiatric disease that is likely to impair compliance with the study protocol, in the judgement of the investigator
- Pregnancy
About this study
Official title: Left Ventricular Papillary Muscle Sling for Heart Failure With Reduced Ejection Fraction (Papillary Muscle Sling)
The purpose of this research is to investigate the effect of using this surgical technique in conjunction with bypass surgery to improve heart function and size, as well as decrease the possibility of future mitral valve surgery.
Read the detailed description
The Sling is used to draw together the ventricular walls at the base of the papillary muscles. This technique has previously been used in conjunction with mitral valve surgery, and has shown significant benefits for the patients.
The reduction in the lateral inter-papillary muscle separation and in the left ventricular volume provided by this technique is expected to improve ventricular function, limit progression of ventricular dilation, and avoid progression of MR when performed without mitral valve surgery in patients with symptomatic ventricular dilation.
- Conditions
- Heart Failure, Cardiomyopathy, Dilated
- Being tested
- Papillary Muscle Sling, CABG surgery
- Medical subject headings
- Heart Failure, Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Papillary Muscle SlingDevice
The sling is made of a Gore-Tex sheet or by using a 4 mm Gore-Tex vascular graft implanted around the base of the papillary muscles and tightened.
CABG surgeryProcedure or surgery
Standard of care Coronary Artery Bypass Grafting (CABG) surgery will be performed to improve blood flow to the heart by bypassing the narrowed segment of a severely diseased coronary artery
| Study group | Role | What they receive |
|---|---|---|
| Papillary Muscle Sling Group | Experimental | Participants in the papillary muscle sling group will receive the sling technique performed in conjunction with their standard of care (SOC) Coronary Artery Bypass Grafting (CABG) surgery. Receives: Device: Papillary Muscle Sling; Procedure: CABG surgery |
| Controls Group | Active comparator | Participants in the control group will receive their SOC CABG surgery only, without any additional intervention. Receives: Procedure: CABG surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular function as assessed by LVEF
Change in Left Ventricular Ejection Fraction (LVEF) will be reported as a change in percent ejection fraction assessed via echocardiogram
Measured: Baseline, up to 5 years
Change in left ventricular volume
End systolic and end diastolic left ventricular volumes will both be evaluated in mL using echocardiogram.
Measured: Baseline, up to 5 years
Secondary outcomes (8)
Mortality Rate
Rate of reported mortality rate will be evaluated.
Measured: 5 years
Number of Major Adverse Cardiac Events (MACE)
MACE is defined as a composite of clinical events comprised of death, stroke, worsening heart failure defined as +1 New York Heart Association (NYHA) class, Congestive Heart Failure (CHF) hospitalization and mitral valve intervention as evaluated by treating physician
Measured: 5 years
Percentage of participants at each FMR severity grade
Functional Mitral Regurgitation (FMR) severity is graded on a scale of 1 to 4 with 1 = none, 2 =mild, 3 = moderate and 4 =severe. This outcome will report the percentage of participants with reported none, mild, moderate or severe mitral regurgitation as assessed via echocardiogram by treating physician.
Measured: Baseline, up to 5 years
Change in MLHF Questionnaire Score
Minnesota Living with Heart Failure (MLHF) is a 21-item questionnaire with a total score ranging from 0 (indicating heart failure has no affect to life) to 105 (indicating the greatest affect to life).
Measured: Baseline, up to 5 years
Change in Functional Status as assessed by 6MWT
Functional status will be assessed as the distance reached in meters via the 6-minute Walk Test (6MWT).
Measured: Baseline, up to 5 years
All Cause Readmission Rate
All cause readmission rate will be calculated for any case throughout the duration of study participation.
Measured: 5 years
Heart Failure Readmission Rate
Heart failure readmission rate will be calculated for heart failure throughout the duration of study participation.
Measured: 5 years
Incidence of Mitral Leaflet Tenting
Mitral Leaflet tenting will be evaluated using echocardiographic imaging.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start12 Dec 2021 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Difficulty with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Lamelas, University of Miami
- Investigators
- Joseph Lamelas, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475315
- Sponsor's protocol ID
- 20200679
- Status last verified
- May 2022
- First submitted
- 10 Jul 2020
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lamelas J, Mihos C, Santana O. Surgical technique: papillary muscle sling for functional mitral regurgitation during minimally invasive valve surgery. Heart Surg Forum. 2013 Oct;16(5):E295-7. doi: 10.1532/hsf98.2013209.
PubMed 24364086Santana O, Solenkova NV, Pineda AM, Mihos CG, Lamelas J. Minimally invasive papillary muscle sling placement during mitral valve repair in patients with functional mitral regurgitation. J Thorac Cardiovasc Surg. 2014 Jan;147(1):496-9. doi: 10.1016/j.jtcvs.2013.03.006. Epub 2013 Mar 29.
PubMed 23545430
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Papillary Muscle Sling for Heart Failure With Reduced Ejection Fraction (Papillary Muscle Sling)
- ClinicalTrials.gov ID
- NCT04475315
- Acronym / sponsor ID
- 20200679
- Conditions
- Heart Failure, Cardiomyopathy, Dilated
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty with recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 12 Dec 2021 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Jul 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.
The purpose of this research is to investigate the effect of using this surgical technique in conjunction with bypass surgery to improve heart function and size, as well as decrease the possibility of future mitral valve surgery.
Detailed description
The Sling is used to draw together the ventricular walls at the base of the papillary muscles. This technique has previously been used in conjunction with mitral valve surgery, and has shown significant benefits for the patients.
The reduction in the lateral inter-papillary muscle separation and in the left ventricular volume provided by this technique is expected to improve ventricular function, limit progression of ventricular dilation, and avoid progression of MR when performed without mitral valve surgery in patients with symptomatic ventricular dilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Papillary Muscle Sling Group | Experimental | Device: Papillary Muscle Sling, Procedure: CABG surgeryParticipants in the papillary muscle sling group will receive the sling technique performed in conjunction with their standard of care (SOC) Coronary Artery Bypass Grafting (CABG) surgery. |
| Controls Group | Active comparator | Procedure: CABG surgeryParticipants in the control group will receive their SOC CABG surgery only, without any additional intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with symptomatic heart failure with reduced ejection fraction and either ischemic or non-ischemic cardiomyopathies, referred for CABG surgery. Suitability for the ventricular sling procedure is determined by the surgeon and or cardiologist, using some or all the criteria described below:
- Left ventricular end diastolic diameter is greater than or equal to 55mm.
- Ejection fraction ≥20% and ≤40%
- FMR grade ≤ 2+ (≤ mild FMR) as defined by the guidelines of the American society of echocardiography at the time of the study approval (via a transthoracic or transesophageal echo).
- End-systolic Interpapillary muscle distance ≥ 20mm
Key exclusion criteria (12 listed)
- Any evidence of structural (chordal or leaflet) mitral lesions.
- Planned concomitant intra-operative procedures (except for closure of patent foramen ovale or atrial septal defect or coronary revascularization)
- Planned concomitant intra-operative Maze procedure for symptomatic paroxysmal atrial fibrillation.
- Persistent atrial fibrillation
- Prior mitral valve repair
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 |
|---|---|---|
| Papillary Muscle SlingThe sling is made of a Gore-Tex sheet or by using a 4 mm Gore-Tex vascular graft implanted around the base of the papillary muscles and tightened. | Device | Papillary Muscle Sling Group |
| CABG surgeryStandard of care Coronary Artery Bypass Grafting (CABG) surgery will be performed to improve blood flow to the heart by bypassing the narrowed segment of a severely diseased coronary artery | Procedure or surgery | Controls Group, Papillary Muscle Sling Group |
Primary outcome
Change in left ventricular function as assessed by LVEF
Time frame: Baseline, up to 5 years
Change in Left Ventricular Ejection Fraction (LVEF) will be reported as a change in percent ejection fraction assessed via echocardiogram
Change in left ventricular volume
Time frame: Baseline, up to 5 years
End systolic and end diastolic left ventricular volumes will both be evaluated in mL using echocardiogram.
8 secondary outcomes
Mortality Rate
Time frame: 5 years
Number of Major Adverse Cardiac Events (MACE)
Time frame: 5 years
Percentage of participants at each FMR severity grade
Time frame: Baseline, up to 5 years
Change in MLHF Questionnaire Score
Time frame: Baseline, up to 5 years
Change in Functional Status as assessed by 6MWT
Time frame: Baseline, up to 5 years
All Cause Readmission Rate
Time frame: 5 years
Heart Failure Readmission Rate
Time frame: 5 years
Incidence of Mitral Leaflet Tenting
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Background: PubMed 24364086Lamelas J, Mihos C, Santana O. Surgical technique: papillary muscle sling for functional mitral regurgitation during minimally invasive valve surgery. Heart Surg Forum. 2013 Oct;16(5):E295-7. doi: 10.1532/hsf98.2013209.
- Background: PubMed 23545430Santana O, Solenkova NV, Pineda AM, Mihos CG, Lamelas J. Minimally invasive papillary muscle sling placement during mitral valve repair in patients with functional mitral regurgitation. J Thorac Cardiovasc Surg. 2014 Jan;147(1):496-9. doi: 10.1016/j.jtcvs.2013.03.006. Epub 2013 Mar 29.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Joseph Lamelas, MD principal investigator
University of Miami
Questions about this trial
What is this clinical trial studying?
A study testing Papillary Muscle Sling and CABG surgery in people with Heart Failure and Cardiomyopathy, Dilated, run by University of Miami.
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 7 inclusion and 12 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: withdrawn, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricular function as assessed by LVEF (time frame: Baseline, up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04475315, which also lists 2 linked publications.
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 11 May 2022.