Mitral RegurgitationPhase 2/3PTOLEMY2CanadaNCT00815386
Safety and Efficacy Study of the PTMA Device to Reduce Mitral Valve Regurgitation in Patients With Heart Failure
A Phase 2/3 study testing Percutaneous transvenous mitral annuloplasty in people with Mitral Regurgitation and Heart Failure, run by Viacor at 3 sites in Canada.
Trial summary
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device residing in the coronary sinus Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mitral Regurgitation, Heart Failure
- What is being tested?
- Percutaneous transvenous mitral annuloplasty
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesCanada
- Study dates
- Feb 2009to Dec 2015
- Phase
- Phase 2/3
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has moderate functional MR: regurgitant orifice area >/= 0.20cm2 or regurgitant volume >/= 30 mL/beat or regurgitant fraction >/= 30%
- Symptomatic heart failure NYHA Class II to IV
- LV dysfunction (25% < LVEF < 50% by echocardiography) OR dilated mitral annulus > 30mm
Who cannot join
- MR of organic origin
- Severe mitral leaflet tethering
- History of MI or PCI within 60 days of study procedure
- Inability to walk a minimum of 100 meters in 6 minutes
- Significant left main stenosis or proximal circumflex stent
- Indication of non-patent CSO or discontinuous CS-GCV-AIV
Show all 10Show fewer
- Bi-ventricular with leads in CS or other devices impeding device placement
- Severe aortic valvular disease
- Chronic corticosteroid use other than < 20mg prednisone for arthritis
- Significant co-morbidities
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Royal Victoria Hospital, McGill University Medical Center
Montreal, Quebec, H3A1A1
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Laval Hospital, Quebec Heart-Lung Institute
Québec, Quebec, G1V4G5
About this study
Official title: Safety and Efficacy of Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients With Heart Failure
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device residing in the coronary sinus
Read the detailed description
Device under Test: The Viacor® Percutaneous Transvenous Mitral Annuloplasty (PTMA) system comprises a sterile implantable cardiac device and associated custom accessories to assist implantation. The PTMA system is intended to treat functional mitral regurgitation (MR) in a heart failure patient by a less invasive method than surgical annuloplasty with greater relief of symptoms than medical management alone.
Study Objective: Functional mitral regurgitation is associated with an adverse prognosis in the heart failure patient. The objective of this study is to evaluate whether PTMA is effective in reducing mitral regurgitation in heart failure patients and whether this reduction is associated with a moderation in the adverse progression of heart failure symptoms.
Hypothesis under Test: Reduction of the severity of functional mitral regurgitation from baseline, as defined by a composite improvement of quantitative echocardiographic metrics, can be achieved safely with the PTMA device and will be associated with a measurable moderation of adverse progression of heart failure symptoms and a moderation of the deterioration of exercise capacity.
- Conditions
- Mitral Regurgitation, Heart Failure
- Being tested
- Percutaneous transvenous mitral annuloplasty
- Keywords
- mitral valve, heart failure, mitral regurgitation, annuloplasty, coronary sinus
- Medical subject headings
- Mitral Valve Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous transvenous mitral annuloplastyDevice
Also called mitral annuloplasty, sinoplasty
Catheterization procedure with anesthesia requiring subclavicular puncture, catheterization of the right atrium and coronary sinus vein, placement and optimization of the PTMA device with access hub remaining subcutaneous at the clavicle.
| Study group | Role | What they receive |
|---|---|---|
| PTMA implanted | Experimental | Enrolled patients receiving a PTMA implant Receives: Device: Percutaneous transvenous mitral annuloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of mitral regurgitation
Measured: 6 months
Freedom from major adverse cardiac events (death, MI, emergent cardiac surgery, and stroke).
Measured: 30 days
Secondary outcomes (4)
Improvement of 6 minute walk distance
Measured: 6 months
Improvement in Quality of Life Score
Measured: 6 months
Reduction of mitral regurgitation
Measured: 6 months
Freedom from procedure-related or device-related major adverse events
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 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionDec 2010
- Study completionDec 2015 (estimated)
Why it stopped: Company ended operations in January 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viacor
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University, Medifacts International Corporation
- Investigators
- Luc Bilodeau, MD, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815386
- Sponsor's protocol ID
- 08-037P
- Acronym
- PTOLEMY2Canada
- Status last verified
- Feb 2011
- First submitted
- 26 Dec 2008
- Last updated
- 14 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dubreuil O, Basmadjian A, Ducharme A, Thibault B, Crepeau J, Lam JY, Bilodeau L. Percutaneous mitral valve annuloplasty for ischemic mitral regurgitation: first in man experience with a temporary implant. Catheter Cardiovasc Interv. 2007 Jun 1;69(7):1053-61. doi: 10.1002/ccd.21186.
PubMed 17525965Fukuda S, Gillinov AM, Liddicoat JR, Saracino G, Hayase M, Cohn WE, Schneider CW, Shiota T. Maintenance of geometric alterations associated with percutaneous mitral valve repair: real-time three-dimensional echocardiographic assessment in an ovine model. J Heart Valve Dis. 2008 May;17(3):276-82.
PubMed 18592924Daimon M, Gillinov AM, Liddicoat JR, Saracino G, Fukuda S, Koyama Y, Hayase M, Cohn WE, Ellis SG, Thomas JD, Shiota T. Dynamic change in mitral annular area and motion during percutaneous mitral annuloplasty for ischemic mitral regurgitation: preliminary animal study with real-time 3-dimensional echocardiography. J Am Soc Echocardiogr. 2007 Apr;20(4):381-8. doi: 10.1016/j.echo.2006.08.029.
PubMed 17400117Noble S, Bilodeau L. [Percutaneous therapies for aortic and mitral valvular disease]. Rev Med Suisse. 2007 May 30;3(113):1360-1, 1363-4, 1366-7. French.
PubMed 17645049Daimon M, Shiota T, Gillinov AM, Hayase M, Ruel M, Cohn WE, Blacker SJ, Liddicoat JR. Percutaneous mitral valve repair for chronic ischemic mitral regurgitation: a real-time three-dimensional echocardiographic study in an ovine model. Circulation. 2005 May 3;111(17):2183-9. doi: 10.1161/01.CIR.0000163547.03188.AC. Epub 2005 Apr 25.
PubMed 15851597Liddicoat 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 14571496
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT00815386
- Acronym / sponsor ID
- PTOLEMY2Canada / 08-037P
- Conditions
- Mitral Regurgitation, Heart Failure
- Keywords
- mitral valve, heart failure, mitral regurgitation, annuloplasty, coronary sinus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Company ended operations in January 2011
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ViacorIndustry (pharma, biotech, devices)
- Collaborators
- Duke University, Medifacts International Corporation
- Study start
- Feb 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 30 Dec 2008 (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.
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device residing in the coronary sinus
Detailed description
Device under Test: The Viacor® Percutaneous Transvenous Mitral Annuloplasty (PTMA) system comprises a sterile implantable cardiac device and associated custom accessories to assist implantation. The PTMA system is intended to treat functional mitral regurgitation (MR) in a heart failure patient by a less invasive method than surgical annuloplasty with greater relief of symptoms than medical management alone.
Study Objective: Functional mitral regurgitation is associated with an adverse prognosis in the heart failure patient. The objective of this study is to evaluate whether PTMA is effective in reducing mitral regurgitation in heart failure patients and whether this reduction is associated with a moderation in the adverse progression of heart failure symptoms.
Hypothesis under Test: Reduction of the severity of functional mitral regurgitation from baseline, as defined by a composite improvement of quantitative echocardiographic metrics, can be achieved safely with the PTMA device and will be associated with a measurable moderation of adverse progression of heart failure symptoms and a moderation of the deterioration of exercise capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTMA implanted | Experimental | Device: Percutaneous transvenous mitral annuloplastyEnrolled patients receiving a PTMA implant |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient has moderate functional MR: regurgitant orifice area >/= 0.20cm2 or regurgitant volume >/= 30 mL/beat or regurgitant fraction >/= 30%
- Symptomatic heart failure NYHA Class II to IV
- LV dysfunction (25% < LVEF < 50% by echocardiography) OR dilated mitral annulus > 30mm
Key exclusion criteria (10 listed)
- MR of organic origin
- Severe mitral leaflet tethering
- History of MI or PCI within 60 days of study procedure
- Inability to walk a minimum of 100 meters in 6 minutes
- Significant left main stenosis or proximal circumflex stent
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 transvenous mitral annuloplastyAlso: mitral annuloplasty, sinoplastyCatheterization procedure with anesthesia requiring subclavicular puncture, catheterization of the right atrium and coronary sinus vein, placement and optimization of the PTMA device with access hub remaining subcutaneous at the clavicle. | Device | PTMA implanted |
Primary outcome
Reduction of mitral regurgitation
Time frame: 6 months
Freedom from major adverse cardiac events (death, MI, emergent cardiac surgery, and stroke).
Time frame: 30 days
4 secondary outcomes
Improvement of 6 minute walk distance
Time frame: 6 months
Improvement in Quality of Life Score
Time frame: 6 months
Reduction of mitral regurgitation
Time frame: 6 months
Freedom from procedure-related or device-related major adverse events
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 14 Feb 2011.
- Background: PubMed 17525965Dubreuil O, Basmadjian A, Ducharme A, Thibault B, Crepeau J, Lam JY, Bilodeau L. Percutaneous mitral valve annuloplasty for ischemic mitral regurgitation: first in man experience with a temporary implant. Catheter Cardiovasc Interv. 2007 Jun 1;69(7):1053-61. doi: 10.1002/ccd.21186.
- Background: PubMed 18592924Fukuda S, Gillinov AM, Liddicoat JR, Saracino G, Hayase M, Cohn WE, Schneider CW, Shiota T. Maintenance of geometric alterations associated with percutaneous mitral valve repair: real-time three-dimensional echocardiographic assessment in an ovine model. J Heart Valve Dis. 2008 May;17(3):276-82.
- Background: PubMed 17400117Daimon M, Gillinov AM, Liddicoat JR, Saracino G, Fukuda S, Koyama Y, Hayase M, Cohn WE, Ellis SG, Thomas JD, Shiota T. Dynamic change in mitral annular area and motion during percutaneous mitral annuloplasty for ischemic mitral regurgitation: preliminary animal study with real-time 3-dimensional echocardiography. J Am Soc Echocardiogr. 2007 Apr;20(4):381-8. doi: 10.1016/j.echo.2006.08.029.
- Background: PubMed 17645049Noble S, Bilodeau L. [Percutaneous therapies for aortic and mitral valvular disease]. Rev Med Suisse. 2007 May 30;3(113):1360-1, 1363-4, 1366-7. French.
- Background: PubMed 15851597Daimon M, Shiota T, Gillinov AM, Hayase M, Ruel M, Cohn WE, Blacker SJ, Liddicoat JR. Percutaneous mitral valve repair for chronic ischemic mitral regurgitation: a real-time three-dimensional echocardiographic study in an ovine model. Circulation. 2005 May 3;111(17):2183-9. doi: 10.1161/01.CIR.0000163547.03188.AC. Epub 2005 Apr 25.
- 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.
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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.
Luc Bilodeau, MD principal investigator
Montreal Heart Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Percutaneous transvenous mitral annuloplasty in people with Mitral Regurgitation and Heart Failure, run by Viacor at 3 sites in Canada.
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 3 inclusion and 10 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: paused, as of the sponsor's last update on 14 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Reduction of mitral regurgitation (time frame: 6 months). 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 NCT00815386, which also lists 6 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 14 Feb 2011.