Mitral Valve RegurgitationPhase 1VIVIDNCT00512005
VIVID - Valvular and Ventricular Improvement Via iCoapsys Delivery - Feasibility Study
A Phase 1 study testing Percutaneous mitral valve repair in people with Mitral Valve Regurgitation and Left Ventricular Dysfunction, run by Myocor at 4 sites in United States.
Trial summary
The purpose of this prospective, non-randomized, single-arm feasibility study is to evaluate safety and feasibility of the iCoapsys System in patients with functional mitral valve insufficiency caused by annular dilation and/or papillary muscle displacement. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mitral Valve Regurgitation, Left Ventricular Dysfunction, Heart Failure
- What is being tested?
- Percutaneous mitral valve repair
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2008to Dec 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grade 3 or 4 functional mitral valve regurgitation per 2D echocardiography.
- NYHA Class II and LVEF greater than or equal to 25% or NYHA Class III and LVEF greater than or equal to 30%
Who cannot join
- History of pericarditis.
- Creatinine > 2.2 at the time of the procedure
- INR > 1.8 at the time of the procedure
- Prior pericardial intervention (including CABG, pericardiotomy or pericardiocentesis).
- Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure (e.g., stent placement).
- Any planned therapeutic interventional or surgical procedure planned within 30 days following the index procedure
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- Open chest surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis).
- Structural abnormality of the mitral valve
- Valve disease resulting in insufficiency or stenosis of the aortic, pulmonary or tricuspid valve requiring intervention.
- Pericardial effusion >5 mm via echocardiography.
- Posterior wall end-diastolic dimension >1.3 cm.
- Left ventricular end diastolic diameter > 7.0 cm.
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Pamela Hyde, RN, 404-712-7665, Pamela.hyde@emoryhealthcare.org
Peter Block, MD
- Recruiting
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, 60201
Claudia Focks, 847-570-2366, cfocks@enh.org
Theodore Feldman, MD
- Recruiting
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55440
Sara Olson, RN, 612-863-7601, sara.olson@allina.com
Wesley Pedersen, MD
- Recruiting
Shawnee Mission Hospital
Shawnee Mission, Kansas, 66204
Millie Salkind, 913-671-6516, msalkind@kcheart.com
Paul Kramer, MD
About this study
Official title: Valvular and Ventricular Improvement Via iCoapsys Delivery (VIVID) Feasibility Study
The purpose of this prospective, non-randomized, single-arm feasibility study is to evaluate safety and feasibility of the iCoapsys System in patients with functional mitral valve insufficiency caused by annular dilation and/or papillary muscle displacement.
Read the detailed description
Functional MR is a frequent outcome of ischemic heart disease or dilated cardiomyopathy. Patients with functional MR generally have normal valvular structures complicated by left ventricular dysfunction. Left ventricular dysfunction will often create geometric distortions that prevent complete leaflet coaptation, rendering the valve incompetent. Changes that will induce functional MR may include (i) dyskinetic or akinetic wall segments, (ii) dilation of the valve annulus or (iii) dilation of the left ventricle leading to tethering of the chordae tendinae.
The iCoapsys Device is intended to treat patients with functional MR. The device is not indicated for patients with diseased or damaged valvular structures caused by rheumatic fever, degenerative diseases, endocarditis, infiltrative diseases or congenital disorders.
- Conditions
- Mitral Valve Regurgitation, Left Ventricular Dysfunction, Heart Failure, Mitral Insufficiency, Mitral Incompetence, Ischemic Heart Disease
- Being tested
- Percutaneous mitral valve repair
- Keywords
- Functional Mitral Regurgitation (FMR), Ischemic Mitral Regurgitation, Less invasive repair, Percutaneous MV repair, Mitral Valve Repair, Heart Failure, Left Ventricular Dysfunction
- Medical subject headings
- Mitral Valve Insufficiency, Ventricular Dysfunction, Left, Heart Failure, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous mitral valve repairDevice
Also called iCoapsys System
Ventricular reshaping to treat functional mitral insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-procedural implant safety of iCoapsys System, Peri-procedural safety of the iCoapsys System, Intra-procedural MR reduction with the iCoapsys System
Measured: Intra-procedure and peri-procedure
Secondary outcomes (1)
Minnesota Living with Heart Failure Questionnaire, 6-Minute Hallwalk, LV Chamber Volumes
Measured: 1, 3, 6, 12, 18, 24 months and annually thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
- Study startJan 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myocor
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512005
- Sponsor's protocol ID
- 030301
- Acronym
- VIVID
- Status last verified
- May 2008
- First submitted
- 6 Aug 2007
- Last updated
- 24 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valvular and Ventricular Improvement Via iCoapsys Delivery (VIVID) Feasibility Study
- ClinicalTrials.gov ID
- NCT00512005
- Acronym / sponsor ID
- VIVID / 030301
- Conditions
- Mitral Valve Regurgitation, Left Ventricular Dysfunction, Heart Failure, Mitral Insufficiency, Mitral Incompetence, Ischemic Heart Disease
- Keywords
- Functional Mitral Regurgitation (FMR), Ischemic Mitral Regurgitation, Less invasive repair, Percutaneous MV repair, Mitral Valve Repair, Heart Failure, Left Ventricular Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- MyocorIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 7 Aug 2007 (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 prospective, non-randomized, single-arm feasibility study is to evaluate safety and feasibility of the iCoapsys System in patients with functional mitral valve insufficiency caused by annular dilation and/or papillary muscle displacement.
Detailed description
Functional MR is a frequent outcome of ischemic heart disease or dilated cardiomyopathy. Patients with functional MR generally have normal valvular structures complicated by left ventricular dysfunction. Left ventricular dysfunction will often create geometric distortions that prevent complete leaflet coaptation, rendering the valve incompetent. Changes that will induce functional MR may include (i) dyskinetic or akinetic wall segments, (ii) dilation of the valve annulus or (iii) dilation of the left ventricle leading to tethering of the chordae tendinae.
The iCoapsys Device is intended to treat patients with functional MR. The device is not indicated for patients with diseased or damaged valvular structures caused by rheumatic fever, degenerative diseases, endocarditis, infiltrative diseases or congenital disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Grade 3 or 4 functional mitral valve regurgitation per 2D echocardiography.
- NYHA Class II and LVEF greater than or equal to 25% or NYHA Class III and LVEF greater than or equal to 30%
Key exclusion criteria (12 listed)
- History of pericarditis.
- Creatinine > 2.2 at the time of the procedure
- INR > 1.8 at the time of the procedure
- Prior pericardial intervention (including CABG, pericardiotomy or pericardiocentesis).
- Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure (e.g., stent placement).
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 |
|---|---|---|
| Percutaneous mitral valve repairAlso: iCoapsys SystemVentricular reshaping to treat functional mitral insufficiency | Device | – |
Primary outcome
Intra-procedural implant safety of iCoapsys System, Peri-procedural safety of the iCoapsys System, Intra-procedural MR reduction with the iCoapsys System
Time frame: Intra-procedure and peri-procedure
1 secondary outcome
Minnesota Living with Heart Failure Questionnaire, 6-Minute Hallwalk, LV Chamber Volumes
Time frame: 1, 3, 6, 12, 18, 24 months and annually thereafter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2009.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Percutaneous mitral valve repair in people with Mitral Valve Regurgitation and Left Ventricular Dysfunction, run by Myocor at 4 sites 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 2 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: status not confirmed, as of the sponsor's last update on 24 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
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 Cyril J. Schweich, MD (763 494 5400, schweich@myocor.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-procedural implant safety of iCoapsys System, Peri-procedural safety of the iCoapsys System, Intra-procedural MR reduction with the iCoapsys System (time frame: Intra-procedure and peri-procedure). 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 24 Jun 2009.