Clinical trial NCT00815386: Safety and Efficacy Study of the PTMA Device to Reduce Mitral Valve Regurgitation in Patients With Heart Failure
Official title: Safety and Efficacy of Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
PHASE3
Conditions: Mitral Regurgitation
Heart Failure
Keywords: mitral valve
heart failure
mitral regurgitation
annuloplasty
coronary sinus
Lead sponsor: Viacor
Sponsor class: INDUSTRY
Collaborators: name: Duke University
name: Medifacts International Corporation
First posted: 2008-12-30
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction of mitral regurgitation
timeFrame: 6 months
measure: Freedom from major adverse cardiac events (death, MI, emergent cardiac surgery, and stroke).
timeFrame: 30 days
Secondary outcomes:
measure: Improvement of 6 minute walk distance
timeFrame: 6 months
measure: Improvement in Quality of Life Score
timeFrame: 6 months
measure: Reduction of mitral regurgitation
timeFrame: 6 months
measure: Freedom from procedure-related or device-related major adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Montreal
country: Canada
facility: Royal Victoria Hospital, McGill University Medical Center
state: Quebec
city: Quebec City
country: Canada
facility: Laval Hospital, Quebec Heart-Lung Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Luc Bilodeau, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1002/ccd.21186.
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.
citation: 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. doi: 10.1016/j.echo.2006.08.029.
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. French.
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. doi: 10.1161/01.CIR.0000163547.03188.AC. Epub 2005 Apr 25.
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. doi: 10.1002/ccd.10662.