Research with human participants

Overview of medical research in the Netherlands

Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation.

No registrations found.

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Ethical review
Positive opinion
Status
Recruitment stopped
Health condition type
-
Study type
Interventional

ID

NL-OMON28876

Source

NTR

Brief title

PTOLEMY

Health condition

Heart Failure
Mitral Regurgitation
Mitral valve disease
Mitral valve insufficiency
Hartfalen
Mitralisklepinsufficiëntie
Mitralisklep
Kleplijden

Sponsors and support

Primary sponsor :
Viacor Inc. (Kate Stohlman)
Source(s) of monetary or material Support :
Sponsor

Intervention

Outcome measures

Primary outcome

Percent of patients who remain free from device-related major adverse events:

- death

- myocardial infarction

- tamponade

- emergent cardiac surgery at 6 months.

Secondary outcome

- Percent of implanted patients who maintain a sustained 1 grade reduction in mitral regurgitation and reduction in mitral anterior posterior dimension at 6 months.

- Improvement of clinical symptoms of heart failure as defined by percent of implanted patients who exhibit one of the following:

* decrease in NYHA class, or increase in Minnesota Living with Heart Failure score, or increase in exercise capacity at 30 days and 6 months.

Study objective

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

Study design

Post-procedural follow-up tup to 5 years.

Intervention

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

Public
Centre Hospitalier Universitaire de Liège
Domaine Universitaire du Sart Tilman Bâtiment B 35 · B-4000 Liège 1
L. Pierard
[default]
Belgium
Scientific
Centre Hospitalier Universitaire de Liège
Domaine Universitaire du Sart Tilman Bâtiment B 35 · B-4000 Liège 1
L. Pierard
[default]
Belgium

Inclusion criteria

1. Symptomatic heart failure

2. Functional MR 2+ - 4+

3. LVEF < 45%

Exclusion criteria

1. MR of organic origins

2. Significant co-morbidities

Design

Study type :
Interventional
Intervention model
:
Other
Allocation :
Non controlled trial
Masking :
Open (masking not used)
Control :
N/A , unknown

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
20
Type :
Actual

Positive opinion
Date :
Application type :
First submission

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
NTR-new NL1278
NTR-old NTR1324
Other Belgian registration number : B7072006352
ISRCTN ISRCTN wordt niet meer aangevraagd

Summary results

Please see under below link:
http://www.viacorinc.com/bibliography.html