Functional Mitral RegurgitationLVRESTORESANCT01899573
Percutaneous Left Ventricular Reshaping to Reduce Functional Mitral Regurgitation and Improve LV Function
A study testing AccuCinch® Ventriculoplasty System in people with Functional Mitral Regurgitation, run by Ancora Heart, Inc. at 1 site in Colombia.
Trial summary
The study is designed to demonstrate the safety, feasibility and potential efficacy of using the AccuCinch® System to reduce functional mitral regurgitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Mitral Regurgitation
- What is being tested?
- AccuCinch® Ventriculoplasty System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteColombia
- Study dates
- Oct 2013to Mar 2016
- 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
- Age >18 years
- Subjects with clinically significant mitral regurgitation (MR 2+ and above)
- Ejection Fraction ≥ 25%
- Stable cardiac medical regimen for heart failure for at least 1 month
- Stable NYHA Classification for at least 1 month
- Subject is eligible for cardiac surgery
- The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent
Who cannot join
- Myocardial infarction within 90 days of the intended treatment with the device
- Prior surgical, transcatheter, or percutaneous mitral valve intervention
- Any intervention for coronary artery disease (CAD) within the last 30 days prior to treatment, or unrevascularized multivessel coronary disease
- Hemodynamic instability or the need for emergent surgery
- Non-ambulatory NYHA Class IV symptoms of heart failure or subjects requiring IV inotropic support
- Subjects in whom sufficient quality of echocardiography (TTE and TEE) cannot be obtained
Show all 27Show fewer
- Echocardiography evidence of primary mitral valve disease causing MR or MS,
- Evidence of mitral valve stenosis with an estimated valve area less than 3.0 cm2
- Mitral valve prosthesis or pathology that would prevent adequate function of the GDS Accucinch System
- Estimated GFR of <30ml/min/1.73m2
- Greater than mild mitral annular calcification observed by fluoroscopy
- Presence of aortic valve prosthesis
- Moderate to severe aortic valve stenosis or calcification observed by echocardiography or fluoroscopy
- Severe aortic arch calcification or mobile aortic atheroma observed by echocardiography or fluoroscopy
- Active bacterial endocarditis
- History of bleeding diathesis or coagulopathy
- History of stroke within the prior 6 months
- Subjects in whom anticoagulation is contraindicated
- Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device.
- Concurrent medical condition with a life expectancy of less than 12 months
- Currently participating in an investigational study
- Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g. severe chronic obstructive pulmonary disease, hepatic failure, immunological abnormalities, and hematological abnormalities)
- Subjects with indication for concomitant surgery such as coronary artery bypass graft (CABG), aortic valve reconstruction or replacement, tricuspid repair or replacement, left ventricular remodeling surgery and congenital repair
- Any cardiac resynchronization therapy within the last 3 months prior to treatment
- Subjects on high dose steroids or immunosuppressant therapy
- Female subjects who are pregnant, of child bearing potential or lactating
- Subjects who are unable or unwilling to comply with the follow-up schedule and requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Percutaneous Left Ventricular Reshaping of Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve LV Function Using the Accucinch® System
The study is designed to demonstrate the safety, feasibility and potential efficacy of using the AccuCinch® System to reduce functional mitral regurgitation.
- Conditions
- Functional Mitral Regurgitation
- Being tested
- AccuCinch® Ventriculoplasty System
- Keywords
- Heart failure, mitral regurgitation, mitral valve
- Medical subject headings
- Heart Failure, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccuCinch® Ventriculoplasty SystemDevice
Percutaneous intervention for the treatment of functional mitral regurgitation
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: AccuCinch® Ventriculoplasty System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac and cardiovascular events
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ancora Heart, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899573
- Sponsor's protocol ID
- 3566
- Acronym
- LVRESTORESA
- Status last verified
- Jun 2017
- First submitted
- 3 Jul 2013
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Percutaneous Left Ventricular Reshaping of Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve LV Function Using the Accucinch® System
- ClinicalTrials.gov ID
- NCT01899573
- Acronym / sponsor ID
- LVRESTORESA / 3566
- Conditions
- Functional Mitral Regurgitation
- Keywords
- Heart failure, mitral regurgitation, mitral valve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Ancora Heart, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 Jul 2013 (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 study is designed to demonstrate the safety, feasibility and potential efficacy of using the AccuCinch® System to reduce functional mitral regurgitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: AccuCinch® Ventriculoplasty System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >18 years
- Subjects with clinically significant mitral regurgitation (MR 2+ and above)
- Ejection Fraction ≥ 25%
- Stable cardiac medical regimen for heart failure for at least 1 month
- Stable NYHA Classification for at least 1 month
Key exclusion criteria (27 listed)
- Myocardial infarction within 90 days of the intended treatment with the device
- Prior surgical, transcatheter, or percutaneous mitral valve intervention
- Any intervention for coronary artery disease (CAD) within the last 30 days prior to treatment, or unrevascularized multivessel coronary disease
- Hemodynamic instability or the need for emergent surgery
- Non-ambulatory NYHA Class IV symptoms of heart failure or subjects requiring IV inotropic support
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 |
|---|---|---|
| AccuCinch® Ventriculoplasty SystemPercutaneous intervention for the treatment of functional mitral regurgitation | Device | Treatment |
Primary outcome
Major adverse cardiac and cardiovascular events
Time frame: 30 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AccuCinch® Ventriculoplasty System in people with Functional Mitral Regurgitation, run by Ancora Heart, Inc. at 1 site in Colombia.
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 27 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: finished, as of the sponsor's last update on 8 Jun 2017. 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 Colombia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Major adverse cardiac and cardiovascular events (time frame: 30 day). 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 8 Jun 2017.