Heart FailurePhase 2PTOLEMY-2NCT00787293
Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients
A Phase 2 study testing PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant in people with Heart Failure and Mitral Regurgitation, run by Viacor at 13 sites in 5 countries.
Trial summary
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure, Mitral Regurgitation
- What is being tested?
- PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 13 sitesin 5 countries
- Study dates
- Oct 2008to Nov 2015
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Functional MR 2+ - 4+
- Symptomatic heart failure, NYHA Class II to IV
- LVEF > 25% or < 50% 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
13 sites in 5 countries.
13 sites in 5 countries
Germany7 sites
Rheinisch-Westfalische Technische Hochschule Universitaetsklinikum Aachen
Aachen, D-52074
Herz-und Diabeteszentrum Nordrhein-Westfalen / Ruhr University of Bochum
Bad Oeynhausen, D-32545
Universitaet Duisburg-Essen Westdeutsches Herzzentrum Universitaetsklinikum Essen
Essen, D-45122
CardioVascular Center Frankfurt Sankt Katharinen
Frankfurt, D-60389
Albert-Ludwigs-Universitat Freiburg Mediziniche Universitätsklinikum Freiburg
Freiburg im Breisgau, D-79095
Städtische Klinikum Karlsruhe GmbH
Karlsruhe, D-76133
Klinikum Schwabing Städtisches Klinikum München GmbH
München, D-80804
Belgium2 sites
Onze Lieve Vrouw Ziekenhuis Cardiovasculair Ondrezoek Aalst
Aalst, B-9300
Centre Hospitalier Universitaire de Liège
Liège, B-4000
Netherlands2 sites
Thoraxcentrum Erasmus Medisch Centrum
Rotterdam, N-3015
Universitair Medisch Centrum Utrecht
Utrecht, N-3584
About this study
Official title: A Multi-center Study of the Safety and Efficacy of the 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.
- Conditions
- Heart Failure, Mitral Regurgitation
- Being tested
- PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
- Keywords
- Heart Failure, Mitral Regurgitation, Percutaneous, Coronary sinus
- 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.
PTMA (Percutaneous Transvenous Mitral Annuloplasty) ImplantDevice
Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein, anterior interventricular vein.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patient is screened for study and given baseline assessments. Pending fulfillment of study eligibility criteria, patient is implanted with PTMA system. Receives: Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from MACE at 30 days post-procedure and quantitative MR reduction at 6 months
Measured: 30 days to 6 months
Secondary outcomes (3)
% of patients experiencing procedure or device-related adverse events
Measured: 30 days to 6 months
Technical procedural success: % of patients maintaining a reduction of mitral annulus A/P dimension, sustained MR reduction, and decrease in left ventricular dimensions to specified degrees
Measured: 6 months
Clinical status: % of treated patients exhibiting improvements in defined QoL parameters
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 posted7 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionNov 2010
- Study completionNov 2015 (estimated)
Why it stopped: Company ended operations January 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viacor
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University, Medifacts International Corporation
- Investigators
- Stefan Sack, Md, PhD, Principal investigator, Klinikum Schwabing, Staedtisches Klinikum Muenchen GmbHRainer Hoffmann, MD, Principal investigator, R-WTH Universitätsklinikum Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787293
- Sponsor's protocol ID
- 08-010P
- Acronym
- PTOLEMY-2
- Status last verified
- Feb 2011
- First submitted
- 5 Nov 2008
- Last updated
- 14 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fukuda 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 17400117Dubreuil 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 17525965Daimon 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
- A Multi-center Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT00787293
- Acronym / sponsor ID
- PTOLEMY-2 / 08-010P
- Conditions
- Heart Failure, Mitral Regurgitation
- Keywords
- Heart Failure, Mitral Regurgitation, Percutaneous, Coronary sinus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Company ended operations January 2011
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ViacorIndustry (pharma, biotech, devices)
- Collaborators
- Duke University, Medifacts International Corporation
- Study start
- Oct 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2015 (estimated)
- First posted
- 7 Nov 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) ImplantPatient is screened for study and given baseline assessments. Pending fulfillment of study eligibility criteria, patient is implanted with PTMA system. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Functional MR 2+ - 4+
- Symptomatic heart failure, NYHA Class II to IV
- LVEF > 25% or < 50% 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 |
|---|---|---|
| PTMA (Percutaneous Transvenous Mitral Annuloplasty) ImplantPercutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein, anterior interventricular vein. | Device | 1 |
Primary outcome
Freedom from MACE at 30 days post-procedure and quantitative MR reduction at 6 months
Time frame: 30 days to 6 months
3 secondary outcomes
% of patients experiencing procedure or device-related adverse events
Time frame: 30 days to 6 months
Technical procedural success: % of patients maintaining a reduction of mitral annulus A/P dimension, sustained MR reduction, and decrease in left ventricular dimensions to specified degrees
Time frame: 6 months
Clinical status: % of treated patients exhibiting improvements in defined QoL parameters
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 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 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 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.
Stefan Sack, Md, PhD principal investigator
Klinikum Schwabing, Staedtisches Klinikum Muenchen GmbH
Rainer Hoffmann, MD principal investigator
R-WTH Universitätsklinikum Aachen
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant in people with Heart Failure and Mitral Regurgitation, run by Viacor at 13 sites in 5 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 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 13 sites in Germany, Belgium, Netherlands, Czechia, Switzerland. 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?
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?
Freedom from MACE at 30 days post-procedure and quantitative MR reduction at 6 months (time frame: 30 days to 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 NCT00787293, which also lists 5 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.