Mitral RegurgitationPhase 1MiRBiNCT01242397
Mitral Insufficiency Reduction With Biventricular Pacing
A Phase 1 study testing CRT pacing in people with Mitral Regurgitation, run by Trinity Medical Center, Illinois.
Trial summary
The purpose of this study is to show that CRT(Cardiac Resynchronization Therapy) pacing in patients with severe functional MR (Mitral Regurgitation) who are not currently indicated for CRT will demonstrate chronic benefit of MR reduction( via echo measured MR/LA area and ERO per American Society of ECHO guidelines)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- CRT pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jan 2013
- Phase
- Phase 1
- 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
- Patient is at least 18 years of age
- Patients with moderate-to-severe or severe functional MR.
- EROA > 40 mm2 and an MR/LA > 40% (severe)
- 30 ≤ EROA ≤ 40 mm2 and 30 ≤ MR/LA ≤ 40% (moderate-to-severe)
- Baseline rates of 50-90 beats per minute (patients with sinus rhythm) or AF
- QRS < 120 ms
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- LVEF < 35%
- Willing to sign informed consent
- On standard stable heart failure medical regimen (beta blockers and ACE-I or ARBs) for at least 1 month before randomization, if tolerated
- Patient has the ability to understand the requirements of the study, including consent for use and disclosure of research-related information
- Patient has the ability to comply with study procedures and protocol, including required study visits
Who cannot join
- candidate for CRT or has a previously implanted CRT device
- previously implanted implantable pulse generators (IPG) or implantable cardioverter defibrillator (ICD) with at least 10 % pacing in the right ventricle
- patient has life expectancy <6 months
- patient is pregnant
- significant aortic stenosis
- uncontrolled hypertension
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- mitral valve stenosis
- severe mitral valve calcification
- ruptured chordae tendinae or papillary muscle
- mitral valve leaflet disorders (i.e. endocarditis, lupus, tumors, rheumatic heart disease)
- chronic mitral leaflet degeneration (ie. Marfans)
- previous valve replacement or surgery
- IV inotropes or IV vasodilators
- candidate for mitral valve repair or replacement surgery within the next 6 months
- patient has in-hospital acute coronary syndrome (ACS) (NSTEMI/STEMI) prior to randomization
- patient has planned or elective percutaneous coronary intervention (PCI) or other non-cardiac surgery prior to randomization
- patient is currently enrolled in an investigational drug or device study
- patient is clinically unstable per PI assessment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective.Randomized, Blinded, Crossover Chronic IDE Study of the Effects of Pacing on Mitral Regurgitation in Patients Without Standard Indications for Cardiac Resynchronization Therapy
The purpose of this study is to show that CRT(Cardiac Resynchronization Therapy) pacing in patients with severe functional MR (Mitral Regurgitation) who are not currently indicated for CRT will demonstrate chronic benefit of MR reduction( via echo measured MR/LA area and ERO per American Society of ECHO guidelines) and to show that CRT pacing is safe in these patients.
Read the detailed description
Approximately 50 patients will be randomized, followed and analyzed in this prospective study. Patients who meet all inclusion and no exclusion criteria will be enrolled and implanted with a CRT system. Baseline evaluation, which includes clinical symptom evaluation and an echocardiogram, will be performed at the time of randomization, which should occur as soon after device implant as possible but no later than 2 week post -implant. The baseline echocardiogram should be acquired prior to the device being programmed to the randomized setting. Repeat echocardiograms and scheduled follow-up evaluations will be performed at the end of each 3 month crossover period.
- Conditions
- Mitral Regurgitation
- Being tested
- CRT pacing
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT pacingDevice
The chronic effect of CRT pacing on the degree of MR in pts with severe-to-moderate or severe functional MR. The treatment being studied is CRT pacing therapy with standard of care LV lead placement. Patients will be randomized to CRT pacing ON vs. OFF and followed for a total of up to 8 months. This includes two 3-month crossover periods for each pacing modality (CRT ON and CRT OFF) and a 6-week washout period between these periods.
| Study group | Role | What they receive |
|---|---|---|
| CRT ON | Other | After implant, patients will be randomized to CRT pacing ON vs OFF in crossover fashion with 3 months in each period Receives: Device: CRT pacing |
| CRT- OFF | Other | After implant, patients will be randomized to CRT pacing OFF vs ON in crossover fashion with 3 months in each period Receives: Device: CRT pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic(8 months post-implant) benefit of MR reduction
To show that CRT pacing in patients with severe functional MR who are not currently indicated for CRT will demonstrate chronic(8 months post-implant) benefit of MR reduction (via echo measured MR/LA area and ERO per American Society of Echo guidelines)
Measured: Chronic
Secondary outcomes (1)
To compare MR Severity (ERO and MR/LA area), heart volume and dimensions via echo and clinical symptoms between two pacing modalities
Secondary objectives will compare MR severity (ERO and MR/LA area), heart volume and dimensions via echo (LA and LV), LVEF via echo (Simpson's method and clinical sypmtoms (NYHA class, QOL, 6MHW distance) between the two pacing modalities (CRT ON and OFF)
Measured: Chronic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trinity Medical Center, Illinois
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Duke University, Massachusetts General Hospital, Augusta University
- Investigators
- Helbert Acosta, MD, Principal investigator, Trinity Medical CenterPatrick Hranitzky, MD, Principal investigator, Duke UniversityJagmeet Singh, MD, Principal investigator, Massachusetts General HospitalAdam A Berman, MD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242397
- Sponsor's protocol ID
- MiRBi- Acosta
- Acronym
- MiRBi
- Status last verified
- Nov 2009
- First submitted
- 10 Nov 2010
- Last updated
- 2 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective.Randomized, Blinded, Crossover Chronic IDE Study of the Effects of Pacing on Mitral Regurgitation in Patients Without Standard Indications for Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT01242397
- Acronym / sponsor ID
- MiRBi / MiRBi- Acosta
- Conditions
- Mitral Regurgitation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Trinity Medical Center, IllinoisUniversity, hospital or other
- Collaborators
- Medtronic, Duke University, Massachusetts General Hospital, Augusta University
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 17 Nov 2010 (estimated)
- 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 study is to show that CRT(Cardiac Resynchronization Therapy) pacing in patients with severe functional MR (Mitral Regurgitation) who are not currently indicated for CRT will demonstrate chronic benefit of MR reduction( via echo measured MR/LA area and ERO per American Society of ECHO guidelines) and to show that CRT pacing is safe in these patients.
Detailed description
Approximately 50 patients will be randomized, followed and analyzed in this prospective study. Patients who meet all inclusion and no exclusion criteria will be enrolled and implanted with a CRT system. Baseline evaluation, which includes clinical symptom evaluation and an echocardiogram, will be performed at the time of randomization, which should occur as soon after device implant as possible but no later than 2 week post -implant. The baseline echocardiogram should be acquired prior to the device being programmed to the randomized setting. Repeat echocardiograms and scheduled follow-up evaluations will be performed at the end of each 3 month crossover period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT ON | Other | Device: CRT pacingAfter implant, patients will be randomized to CRT pacing ON vs OFF in crossover fashion with 3 months in each period |
| CRT- OFF | Other | Device: CRT pacingAfter implant, patients will be randomized to CRT pacing OFF vs ON in crossover fashion with 3 months in each period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient is at least 18 years of age
- Patients with moderate-to-severe or severe functional MR.
- Baseline rates of 50-90 beats per minute (patients with sinus rhythm) or AF
- QRS < 120 ms
- LVEF < 35%
Key exclusion criteria (18 listed)
- candidate for CRT or has a previously implanted CRT device
- previously implanted implantable pulse generators (IPG) or implantable cardioverter defibrillator (ICD) with at least 10 % pacing in the right ventricle
- patient has life expectancy <6 months
- patient is pregnant
- significant aortic stenosis
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 |
|---|---|---|
| CRT pacingThe chronic effect of CRT pacing on the degree of MR in pts with severe-to-moderate or severe functional MR. The treatment being studied is CRT pacing therapy with standard of care LV lead placement. Patients will be randomized to CRT pacing ON vs. OFF and followed for a total of up to 8 months. This includes two 3-month crossover periods for each pacing modality (CRT ON and CRT OFF) and a 6-week washout period between these periods. | Device | CRT ON, CRT- OFF |
Primary outcome
Chronic(8 months post-implant) benefit of MR reduction
Time frame: Chronic
To show that CRT pacing in patients with severe functional MR who are not currently indicated for CRT will demonstrate chronic(8 months post-implant) benefit of MR reduction (via echo measured MR/LA area and ERO per American Society of Echo guidelines)
1 secondary outcome
To compare MR Severity (ERO and MR/LA area), heart volume and dimensions via echo and clinical symptoms between two pacing modalities
Time frame: Chronic
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2010.
Related trials for Mitral Regurgitation
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Recruiting
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Atrial Functional, Mitral Regurgitation (MR)
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A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
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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.
Helbert Acosta, MD principal investigator
Trinity Medical Center
Patrick Hranitzky, MD principal investigator
Duke University
Jagmeet Singh, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CRT pacing in people with Mitral Regurgitation, run by Trinity Medical Center, Illinois.
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 11 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 2 Dec 2010. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helbert Acosta, MD (309-236-0810, mirbiacosta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic(8 months post-implant) benefit of MR reduction (time frame: Chronic). 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 2 Dec 2010.