Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients

Heart Failure Clinical Trial

— PTOLEMY-2  

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00787293
• Other study ID #: 08-010P
• Status: Suspended
• Phase: Phase 2
• First received: November 5, 2008
• Last updated: February 10, 2011
• Start date: October 2008
• Est. completion date: November 2015

Study information

• Verified date: February 2011
• Source: Viacor
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: November 2015
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Functional MR 2+ - 4+

• Symptomatic heart failure, NYHA Class II to IV

• LVEF > 25% or < 50% OR dilated mitral annulus > 30mm

Exclusion Criteria:

• 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

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein, anterior interventricular vein.

Locations

Country	Name	City	State
Belgium	Onze Lieve Vrouw Ziekenhuis Cardiovasculair Ondrezoek Aalst	Aalst
Belgium	Centre Hospitalier Universitaire de Liège	Liège
Czech Republic	Institut Klinicke a Experimentalni Mediciny	Prague
Germany	Rheinisch-Westfalische Technische Hochschule Universitaetsklinikum Aachen	Aachen
Germany	Herz-und Diabeteszentrum Nordrhein-Westfalen / Ruhr University of Bochum	Bad Oeynhausen
Germany	Universitaet Duisburg-Essen Westdeutsches Herzzentrum Universitaetsklinikum Essen	Essen
Germany	CardioVascular Center Frankfurt Sankt Katharinen	Frankfurt
Germany	Albert-Ludwigs-Universitat Freiburg Mediziniche Universitätsklinikum Freiburg	Freiburg im Breisgau
Germany	Städtische Klinikum Karlsruhe GmbH	Karlsruhe
Germany	Klinikum Schwabing Städtisches Klinikum München GmbH	München
Netherlands	Thoraxcentrum Erasmus Medisch Centrum	Rotterdam
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Switzerland	Hôpital Universitaire de Genève	Geneva

Sponsors (3)

Lead Sponsor	Collaborator
Viacor	Duke University, Medifacts International Corporation

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Germany,  Netherlands,  Switzerland, 

References & Publications (5)

Daimon 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. — View Citation

Daimon 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. Epub 2005 Apr 25. — View Citation

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. — View Citation

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. — View Citation

Liddicoat 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from MACE at 30 days post-procedure and quantitative MR reduction at 6 months		30 days to 6 months	Yes
Secondary	% of patients experiencing procedure or device-related adverse events		30 days to 6 months	Yes
Secondary	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		6 months	No
Secondary	Clinical status: % of treated patients exhibiting improvements in defined QoL parameters		6 months	No

External Links

•   company website including information in Dutch, German, and French