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

NCT00787293 | Suspended Phase 2 DMC

• 1 other identifier: 08-010P
• Study Type: interventional
• Target: 30
• Locations: 5 countries
• Sites: 13

Brief Summary

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

Conditions

Heart Failure; Mitral Regurgitation

Keywords

Heart Failure; Mitral Regurgitation; Percutaneous; Coronary sinus

Outcome Measures

Primary Outcomes (1)

• Freedom from MACE at 30 days post-procedure and quantitative MR reduction at 6 months

  30 days to 6 months

Secondary Outcomes (3)

• % of patients experiencing procedure or device-related adverse events

  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

  6 months

• Clinical status: % of treated patients exhibiting improvements in defined QoL parameters

  6 months

Study Arms (1)

1

EXPERIMENTAL

Patient is screened for study and given baseline assessments. Pending fulfillment of study eligibility criteria, patient is implanted with PTMA system.

Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant

Interventions

PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant DEVICE

Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein, anterior interventricular vein.

1

Eligibility Criteria

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

You may qualify if:

• Functional MR 2+ - 4+
• Symptomatic heart failure, NYHA Class II to IV
• LVEF \> 25% or \< 50% 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 (13)

Onze Lieve Vrouw Ziekenhuis Cardiovasculair Ondrezoek Aalst

Aalst, B-9300, Belgium

Location

Centre Hospitalier Universitaire de Liège

Liège, B-4000, Belgium

Location

Institut Klinicke a Experimentalni Mediciny

Prague, 1958/9, Czechia

Location

Rheinisch-Westfalische Technische Hochschule Universitaetsklinikum Aachen

Aachen, D-52074, Germany

Location

Herz-und Diabeteszentrum Nordrhein-Westfalen / Ruhr University of Bochum

Bad Oeynhausen, D-32545, Germany

Location

Universitaet Duisburg-Essen Westdeutsches Herzzentrum Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

CardioVascular Center Frankfurt Sankt Katharinen

Frankfurt, D-60389, Germany

Location

Albert-Ludwigs-Universitat Freiburg Mediziniche Universitätsklinikum Freiburg

Freiburg im Breisgau, D-79095, Germany

Location

Städtische Klinikum Karlsruhe GmbH

Karlsruhe, D-76133, Germany

Location

Klinikum Schwabing Städtisches Klinikum München GmbH

München, D-80804, Germany

Location

Thoraxcentrum Erasmus Medisch Centrum

Rotterdam, N-3015, Netherlands

Location

Universitair Medisch Centrum Utrecht

Utrecht, N-3584, Netherlands

Location

Hôpital Universitaire de Genève

Geneva, 1211, Switzerland

Location

Related Publications (5)

• 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

• 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

• 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

Heart Failure; Mitral Valve Insufficiency

Interventions

Mutagenesis, Insertional

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Protein Engineering; Genetic Engineering; Genetic Techniques; Investigative Techniques; Mutation; Genetic Variation; Genetic Phenomena; Mutagenesis

Study Officials

• Stefan Sack, Md, PhD

  Klinikum Schwabing, Staedtisches Klinikum Muenchen GmbH

  PRINCIPAL INVESTIGATOR

• Rainer Hoffmann, MD

  R-WTH Universitätsklinikum Aachen

  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: November 5, 2008
• First Posted: November 7, 2008
• Study Start: October 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2015
• Last Updated: February 14, 2011

Record last verified: 2011-02

Locations

CZ (1); CH (1); DE (7); NL (2); BE (2)