Safety and Efficacy Study of the PTMA Device to Reduce Mitral Valve Regurgitation in Patients With Heart Failure

Heart Failure Clinical Trial

— PTOLEMY2Canada  

Official title:

Safety and Efficacy of Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients With Heart Failure

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00815386
• Other study ID #: 08-037P
• Status: Suspended
• Phase: Phase 2/Phase 3
• First received: December 26, 2008
• Last updated: February 10, 2011
• Start date: February 2009
• Est. completion date: December 2015

Study information

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

Clinical Trial Summary

Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device residing in the coronary sinus

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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

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:
• Percutaneous transvenous mitral annuloplasty
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.

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital, McGill University Medical Center	Montreal	Quebec
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Laval Hospital, Quebec Heart-Lung Institute	Quebec City	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Viacor	Duke University, Medifacts International Corporation

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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

Noble 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. Review. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of mitral regurgitation		6 months	No
Primary	Freedom from major adverse cardiac events (death, MI, emergent cardiac surgery, and stroke).		30 days	Yes
Secondary	Improvement of 6 minute walk distance		6 months	No
Secondary	Improvement in Quality of Life Score		6 months	No
Secondary	Reduction of mitral regurgitation		6 months	No
Secondary	Freedom from procedure-related or device-related major adverse events		6 months	Yes

External Links

•   Sponsor Web Page (multi-lingual)