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


- candidate number3307
- NTR NumberNTR1324
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-mei-2008
- Secondary IDsB7072006352 Belgian registration number
- Public TitleSafety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation.
- Scientific TitleAn Open-Label, Single-Arm Pilot Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device Used to Reduce Mitral Regurgitation
- ACRONYMPTOLEMY
- hypothesisImprovement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device
- Healt Condition(s) or Problem(s) studiedHeart failure, Mitral valve insufficiency, Mitral valve, Mitral regurgitation, Valve disease
- Inclusion criteria1. Symptomatic heart failure
2. Functional MR 2+ - 4+
3. LVEF < 45%
- Exclusion criteria1. MR of organic origins
2. Significant co-morbidities
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 20-jun-2006
- planned closingdate1-jan-2013
- Target number of participants20
- InterventionsPatient is screened for study and given baseline assessments. Patient receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant.
- Primary outcomePercent 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.
- TimepointsPost-procedural follow-up tup to 5 years.
- Trial web sitehttp://www.viacor.com
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. L. Pierard
- CONTACT for SCIENTIFIC QUERIES Kate Stohlman
- Sponsor/Initiator Viacor, Inc.
- Funding
(Source(s) of Monetary or Material Support)
Viacor, Inc.
- PublicationsPlease see under below link: http://www.viacorinc.com/bibliography.html
- Brief summary
- Main changes (audit trail)
- RECORD20-mei-2008 - 2-nov-2008


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