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Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device (PTOLEMY)

Primary Purpose

Heart Failure, Mitral Regurgitation

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
Sponsored by
Viacor
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Mitral Regurgitation

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Functional MR 2+ - 4+ with left ventricular enlargement
  • Symptomatic heart failure
  • 20% - 50% LVEF

Exclusion Criteria:

  • mitral regurgitation of organic origins
  • recent cardiac interventions
  • severe comorbidities

Sites / Locations

  • Montreal Heart Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Patient is screened for study and given baseline assessments. Patient receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant.

Outcomes

Primary Outcome Measures

percent of patients who remain free from device-related major adverse events (death, myocardial infarction, tamponade, emergent cardiac surgery

Secondary Outcome Measures

percent of implanted patients who maintain a sustained 1 grade reduction in MR and reduction of mitral annulus anterior posterior dimension
percent of implanted patients who exhibit improvement of clinical symptoms as one of the following: decrease in NYHA class, improvement of Minnesota QOL survey, increase exercise capacity 6 minute walk or improvement in VO2 max

Full Information

First Posted
November 30, 2007
Last Updated
November 5, 2008
Sponsor
Viacor
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1. Study Identification

Unique Protocol Identification Number
NCT00571610
Brief Title
Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device
Acronym
PTOLEMY
Official Title
A Single-Center, Open-Label, Single-Arm Pilot Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Implantable Device Used to Reduce Mitral Valve Regurgitation.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Viacor

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary sinus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Mitral Regurgitation
Keywords
Heart Failure, Mitral Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patient is screened for study and given baseline assessments. Patient receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant.
Intervention Type
Device
Intervention Name(s)
PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
Intervention Description
Percutaneous access from right or left subclavian vein, diagnostic assessment, then placement of the PTMA implant in the coronary sinus, great cardiac vein.
Primary Outcome Measure Information:
Title
percent of patients who remain free from device-related major adverse events (death, myocardial infarction, tamponade, emergent cardiac surgery
Time Frame
30 days
Secondary Outcome Measure Information:
Title
percent of implanted patients who maintain a sustained 1 grade reduction in MR and reduction of mitral annulus anterior posterior dimension
Time Frame
30 days
Title
percent of implanted patients who exhibit improvement of clinical symptoms as one of the following: decrease in NYHA class, improvement of Minnesota QOL survey, increase exercise capacity 6 minute walk or improvement in VO2 max
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Functional MR 2+ - 4+ with left ventricular enlargement Symptomatic heart failure 20% - 50% LVEF Exclusion Criteria: mitral regurgitation of organic origins recent cardiac interventions severe comorbidities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Bilodeau, MD
Organizational Affiliation
Montreal Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17525965
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.
Results Reference
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Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device

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