Mitral Valve RegurgitationPhase 2DYANANCT00833014
Dynamic Annuloplasty System With Activation for the Treatment of Mitral Regurgitation
A Phase 2 study testing Dynamic Annuloplasty Ring (with option to adjust off-pump) in people with Mitral Valve Regurgitation, run by MiCardia Corporation at 5 sites in 3 countries.
Trial summary
The device is a dynamic annuloplasty ring/band that is able to be adjusted in order to correct for mitral regurgitation intraoperatively or postoperatively, off-pump. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Regurgitation
- What is being tested?
- Dynamic Annuloplasty Ring (with option to adjust off-pump)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Dec 2008to Dec 2010
- Phase
- Phase 2
- 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
- This patient requires mitral valve repair with or without concomitant procedures such as coronary artery bypass or another valve reconstruction or replacement.
- This patient has been diagnosed with a diseased natural valve, based on echocardiography and is a candidate for mitral valve repair.
- This patient is in satisfactory condition, based on the physical exam and investigator's experience, to be an average or better operative risk. (i.e., likely to survive one year postoperatively).
- This patient is geographically stable and willing to return to the implant center for follow-up visits.
- This patient has been adequately informed of his/her participation in the clinical study, and of what will be required of him/her, in order to comply with the protocol.
Who cannot join
- This patient is less than eighteen (18) years of age.
- This patient has a non-cardiac major or progressive disease, which in the investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than twelve months.
- This patient has an ejection fraction < 30%.
- This patient has a heavily calcified annulus or leaflets.
- This patient presents with active endocarditis or has had active endocarditis in the last 3 months.
- This patient is pregnant (urine HCG test result positive) or lactating.
Show all 19Show fewer
- This patient is an intravenous drug abuser or alcohol abuser.
- This patient has a previously implanted prosthetic mitral valve.
- This patient requires mitral valve replacement.
- This patient has a creatinine level > 2.0 mg/dl
- This patient has had congestive heart failure within the past 6 months requiring surgical treatment.
- This patient has had a coronary artery ischemic event within the past 6 months.
- This patient has a known life threatening, non-cardiac disease that will limit the patient's life expectancy to less than one year.
- This patient is unable to take Coumadin.
- This patient has a known untreatable allergy to contrast media or nickel.
- This patient has had a cerebral vascular event within the past 6 months.
- This patient is a prisoner (U.S.A. Only).
- This patient is participating in concomitant research studies of investigational products.
- This patient will not agree to return to the implant center for the required number of follow-up visits or is geographically unavailable for follow-up.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Germany3 sites, 3 recruiting
- Recruiting
University of Saarlands
Homburg, 66421
Frank Langer, MD, 06841/1632000, frank.langer@uks.eu
H J Schafers, MD, PhD
- Recruiting
Universitatsklinikum Schleswig-Holstein
Kiel, 24105
Arne M Eide, MD, +1494315974400, eideam@hotmail.com
Jochen Cremer, MD PhD
- Recruiting
University of Leipzig Herzzentrum
Leipzig, 04289
Sissy Ott, +4903418651570, sissy.ott@herzzentrum-leipzig.de
Canada1 site, 1 recruiting
- Not yet recruiting
University of British Columbia
Vancouver, British Columbia, V6Z1Y6
Kevin Schillitto, 604-806-8383, KShillitto@providencehealth.bc.ca
Jian Ye, MD
Netherlands1 site, 1 recruiting
- Not yet recruiting
Erasmus MC
Rotterdam
Liesbeth Duininck, + 310107032150, e.duininck@erasmusmc.nl
Pieter Kappetein, MD PhD
About this study
The device is a dynamic annuloplasty ring/band that is able to be adjusted in order to correct for mitral regurgitation intraoperatively or postoperatively, off-pump.
- Conditions
- Mitral Valve Regurgitation
- Being tested
- Dynamic Annuloplasty Ring (with option to adjust off-pump)
- 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.
Dynamic Annuloplasty Ring (with option to adjust off-pump)Device
Annuloplasty device repair of mitral valve regurgitation with option to adjust device post implant.
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Not described Receives: Device: Dynamic Annuloplasty Ring (with option to adjust off-pump) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from major complications and SAM (Systolic Anterior Motion)
Measured: 6 months
Secondary outcomes (1)
Ability to adjust annuloplasty ring off-pump post implantation to correct for residual regurgitation, reduction of mitral valve regurgitation at follow-up visits (discharge, 30 days, 6 months)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MiCardia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833014
- Sponsor's protocol ID
- TP07-006
- Acronym
- DYANA
- Status last verified
- Jan 2009
- First submitted
- 8 Jan 2009
- Last updated
- 30 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Baev B, Petkov D, Iliev R, Nachev G. [Mitral valve repair for mitral regurgitation--15 year results]. Khirurgiia (Sofiia). 2006;(4-5):19-22. Bulgarian.
PubMed 18843917Manesis EK, Cameron CH, Gregoriadis G. Hepatitis-B-surface-antigen-containing liposomes enhance humoral and cell-mediated immunity to the antigen [proceedings]. Biochem Soc Trans. 1979 Aug;7(4):678-80. doi: 10.1042/bst0070678. No abstract available.
PubMed 225223McGee EC, Gillinov AM, Blackstone EH, Rajeswaran J, Cohen G, Najam F, Shiota T, Sabik JF, Lytle BW, McCarthy PM, Cosgrove DM. Recurrent mitral regurgitation after annuloplasty for functional ischemic mitral regurgitation. J Thorac Cardiovasc Surg. 2004 Dec;128(6):916-24. doi: 10.1016/j.jtcvs.2004.07.037.
PubMed 15573077Sharony R, Saunders PC, Nayar A, McAleer E, Galloway AC, Delianides J, Schwartz CF, Applebaum RM, Kronzon I, Colvin SB, Grossi EA. Semirigid partial annuloplasty band allows dynamic mitral annular motion and minimizes valvular gradients: an echocardiographic study. Ann Thorac Surg. 2004 Feb;77(2):518-22; discussion 522. doi: 10.1016/j.athoracsur.2003.06.005.
PubMed 14759429Hashim SW, Rousou AJ, Geirsson A, Ragnarsson S. Solving the puzzle of chronic ischemic mitral regurgitation. Yale J Biol Med. 2008 Dec;81(4):167-73.
PubMed 19099047Leacche M, Balaguer JM, Byrne JG. Role of cardiac surgery in the post-myocardial infarction patient with heart failure. Curr Heart Fail Rep. 2008 Dec;5(4):204-10. doi: 10.1007/s11897-008-0031-z.
PubMed 19032915Spoor MT, Bolling SF. Valve pathology in heart failure: which valves can be fixed? Heart Fail Clin. 2007 Jul;3(3):289-98. doi: 10.1016/j.hfc.2007.04.008.
PubMed 17723937Bolling SF. Mitral reconstruction in cardiomyopathy. J Heart Valve Dis. 2002 Jan;11 Suppl 1:S26-31.
PubMed 11843517Lloyd-Jones D, Adams R, Carnethon M, De Simone G, Ferguson TB, Flegal K, Ford E, Furie K, Go A, Greenlund K, Haase N, Hailpern S, Ho M, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott M, Meigs J, Mozaffarian D, Nichol G, O'Donnell C, Roger V, Rosamond W, Sacco R, Sorlie P, Stafford R, Steinberger J, Thom T, Wasserthiel-Smoller S, Wong N, Wylie-Rosett J, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2009 Jan 27;119(3):e21-181. doi: 10.1161/CIRCULATIONAHA.108.191261. Epub 2008 Dec 15. No abstract available.
PubMed 19075105Liddicoat JR, Mac Neill BD, Gillinov AM, Cohn WE, Chin CH, Prado AD, Pandian NG, Oesterle SN. Percutaneous mitral valve repair: a feasibility study in an ovine model of acute ischemic mitral regurgitation. Catheter Cardiovasc Interv. 2003 Nov;60(3):410-6. doi: 10.1002/ccd.10662.
PubMed 14571496Bursi F, Enriquez-Sarano M, Nkomo VT, Jacobsen SJ, Weston SA, Meverden RA, Roger VL. Heart failure and death after myocardial infarction in the community: the emerging role of mitral regurgitation. Circulation. 2005 Jan 25;111(3):295-301. doi: 10.1161/01.CIR.0000151097.30779.04. Epub 2005 Jan 17.
PubMed 15655133Badhwar V, Bolling SF. Mitral valve surgery in the patient with left ventricular dysfunction. Semin Thorac Cardiovasc Surg. 2002 Apr;14(2):133-6. doi: 10.1053/stcs.2002.32314.
PubMed 11988951Pfeffer MA, Braunwald E. Ventricular remodeling after myocardial infarction. Experimental observations and clinical implications. Circulation. 1990 Apr;81(4):1161-72. doi: 10.1161/01.cir.81.4.1161.
PubMed 2138525Gillinov AM, Cosgrove DM 3rd. Current status of mitral valve repair. Am Heart Hosp J. 2003 Winter;1(1):47-54. doi: 10.1111/j.1541-9215.2003.02082.x.
PubMed 15785176Moss RR, Humphries KH, Gao M, Thompson CR, Abel JG, Fradet G, Munt BI. Outcome of mitral valve repair or replacement: a comparison by propensity score analysis. Circulation. 2003 Sep 9;108 Suppl 1:II90-7. doi: 10.1161/01.cir.0000089182.44963.bb.
PubMed 12970215
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Annuloplasty System With Activation for the Treatment of Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT00833014
- Acronym / sponsor ID
- DYANA / TP07-006
- Conditions
- Mitral Valve Regurgitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- MiCardia CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 30 Jan 2009 (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 device is a dynamic annuloplasty ring/band that is able to be adjusted in order to correct for mitral regurgitation intraoperatively or postoperatively, off-pump.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Device: Dynamic Annuloplasty Ring (with option to adjust off-pump) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- This patient requires mitral valve repair with or without concomitant procedures such as coronary artery bypass or another valve reconstruction or replacement.
- This patient has been diagnosed with a diseased natural valve, based on echocardiography and is a candidate for mitral valve repair.
- This patient is in satisfactory condition, based on the physical exam and investigator's experience, to be an average or better operative risk. (i.e., likely to survive one year postoperatively).
- This patient is geographically stable and willing to return to the implant center for follow-up visits.
- This patient has been adequately informed of his/her participation in the clinical study, and of what will be required of him/her, in order to comply with the protocol.
Key exclusion criteria (19 listed)
- This patient is less than eighteen (18) years of age.
- This patient has a non-cardiac major or progressive disease, which in the investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than twelve months.
- This patient has an ejection fraction < 30%.
- This patient has a heavily calcified annulus or leaflets.
- This patient presents with active endocarditis or has had active endocarditis in the last 3 months.
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 |
|---|---|---|
| Dynamic Annuloplasty Ring (with option to adjust off-pump)Annuloplasty device repair of mitral valve regurgitation with option to adjust device post implant. | Device | I |
Primary outcome
Freedom from major complications and SAM (Systolic Anterior Motion)
Time frame: 6 months
1 secondary outcome
Ability to adjust annuloplasty ring off-pump post implantation to correct for residual regurgitation, reduction of mitral valve regurgitation at follow-up visits (discharge, 30 days, 6 months)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2009.
- Background: PubMed 18843917Baev B, Petkov D, Iliev R, Nachev G. [Mitral valve repair for mitral regurgitation--15 year results]. Khirurgiia (Sofiia). 2006;(4-5):19-22. Bulgarian.
- Background: PubMed 225223Manesis EK, Cameron CH, Gregoriadis G. Hepatitis-B-surface-antigen-containing liposomes enhance humoral and cell-mediated immunity to the antigen [proceedings]. Biochem Soc Trans. 1979 Aug;7(4):678-80. doi: 10.1042/bst0070678. No abstract available.
- Background: PubMed 15573077McGee EC, Gillinov AM, Blackstone EH, Rajeswaran J, Cohen G, Najam F, Shiota T, Sabik JF, Lytle BW, McCarthy PM, Cosgrove DM. Recurrent mitral regurgitation after annuloplasty for functional ischemic mitral regurgitation. J Thorac Cardiovasc Surg. 2004 Dec;128(6):916-24. doi: 10.1016/j.jtcvs.2004.07.037.
- Background: PubMed 14759429Sharony R, Saunders PC, Nayar A, McAleer E, Galloway AC, Delianides J, Schwartz CF, Applebaum RM, Kronzon I, Colvin SB, Grossi EA. Semirigid partial annuloplasty band allows dynamic mitral annular motion and minimizes valvular gradients: an echocardiographic study. Ann Thorac Surg. 2004 Feb;77(2):518-22; discussion 522. doi: 10.1016/j.athoracsur.2003.06.005.
- Background: PubMed 19099047Hashim SW, Rousou AJ, Geirsson A, Ragnarsson S. Solving the puzzle of chronic ischemic mitral regurgitation. Yale J Biol Med. 2008 Dec;81(4):167-73.
- Background: PubMed 19032915Leacche M, Balaguer JM, Byrne JG. Role of cardiac surgery in the post-myocardial infarction patient with heart failure. Curr Heart Fail Rep. 2008 Dec;5(4):204-10. doi: 10.1007/s11897-008-0031-z.
- Background: PubMed 17723937Spoor MT, Bolling SF. Valve pathology in heart failure: which valves can be fixed? Heart Fail Clin. 2007 Jul;3(3):289-98. doi: 10.1016/j.hfc.2007.04.008.
- Background: PubMed 11843517Bolling SF. Mitral reconstruction in cardiomyopathy. J Heart Valve Dis. 2002 Jan;11 Suppl 1:S26-31.
- Background: PubMed 19075105Lloyd-Jones D, Adams R, Carnethon M, De Simone G, Ferguson TB, Flegal K, Ford E, Furie K, Go A, Greenlund K, Haase N, Hailpern S, Ho M, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott M, Meigs J, Mozaffarian D, Nichol G, O'Donnell C, Roger V, Rosamond W, Sacco R, Sorlie P, Stafford R, Steinberger J, Thom T, Wasserthiel-Smoller S, Wong N, Wylie-Rosett J, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2009 Jan 27;119(3):e21-181. doi: 10.1161/CIRCULATIONAHA.108.191261. Epub 2008 Dec 15. No abstract available.
- Background: PubMed 14571496Liddicoat JR, Mac Neill BD, Gillinov AM, Cohn WE, Chin CH, Prado AD, Pandian NG, Oesterle SN. Percutaneous mitral valve repair: a feasibility study in an ovine model of acute ischemic mitral regurgitation. Catheter Cardiovasc Interv. 2003 Nov;60(3):410-6. doi: 10.1002/ccd.10662.
- Background: PubMed 15655133Bursi F, Enriquez-Sarano M, Nkomo VT, Jacobsen SJ, Weston SA, Meverden RA, Roger VL. Heart failure and death after myocardial infarction in the community: the emerging role of mitral regurgitation. Circulation. 2005 Jan 25;111(3):295-301. doi: 10.1161/01.CIR.0000151097.30779.04. Epub 2005 Jan 17.
- Background: PubMed 11988951Badhwar V, Bolling SF. Mitral valve surgery in the patient with left ventricular dysfunction. Semin Thorac Cardiovasc Surg. 2002 Apr;14(2):133-6. doi: 10.1053/stcs.2002.32314.
- Related InfoLink provided by the sponsor.
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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.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dynamic Annuloplasty Ring (with option to adjust off-pump) in people with Mitral Valve Regurgitation, run by MiCardia Corporation at 5 sites in 3 countries.
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 5 inclusion and 19 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 30 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Canada, Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jody L Errandi, M.S. (949.951.4888 ext. 12, jerrandi@micardia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from major complications and SAM (Systolic Anterior Motion) (time frame: 6 months). 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 NCT00833014, which also lists 23 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 30 Jan 2009.