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

NCT00815386 | Suspended Phase 2 DMC

• 1 other identifier: 08-037P
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Mitral Regurgitation; Heart Failure

Keywords

mitral valve; heart failure; mitral regurgitation; annuloplasty; coronary sinus

Outcome Measures

Primary Outcomes (2)

• Reduction of mitral regurgitation

  6 months

• Freedom from major adverse cardiac events (death, MI, emergent cardiac surgery, and stroke).

  30 days

Secondary Outcomes (4)

• Improvement of 6 minute walk distance

  6 months

• Improvement in Quality of Life Score

  6 months

• Reduction of mitral regurgitation

  6 months

• Freedom from procedure-related or device-related major adverse events

  6 months

Study Arms (1)

PTMA implanted

EXPERIMENTAL

Enrolled patients receiving a PTMA implant

Device: Percutaneous transvenous mitral annuloplasty

Interventions

Percutaneous transvenous mitral annuloplasty DEVICE

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.

Also known as: mitral annuloplasty, sinoplasty

PTMA implanted

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Viacor: lead
• Duke University: collaborator
• Medifacts International Corporation: collaborator

Study Sites (3)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Royal Victoria Hospital, McGill University Medical Center

Montreal, Quebec, H3A1A1, Canada

Location

Laval Hospital, Quebec Heart-Lung Institute

Québec, Quebec, G1V4G5, Canada

Location

Related Publications (6)

• 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.

  PMID: 17525965 BACKGROUND

• 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.

  PMID: 18592924 BACKGROUND

• 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.

  PMID: 17400117 BACKGROUND

• 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.

  PMID: 17645049 BACKGROUND

• 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.

  PMID: 15851597 BACKGROUND

• 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.

  PMID: 14571496 BACKGROUND

MeSH Terms

Conditions

Mitral Valve Insufficiency; Heart Failure

Interventions

Mitral Valve Annuloplasty

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Valve Annuloplasty; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Luc Bilodeau, MD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 26, 2008
• First Posted: December 30, 2008
• Study Start: February 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2015
• Last Updated: February 14, 2011

Record last verified: 2011-02

Locations

CA (3)