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Safety and Efficacy clinical trial of the PTMA System to reduce mitral valve regurgitation in heart failure.


- candidate number4312
- NTR NumberNTR1514
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-okt-2008
- Secondary IDsPTOLEMY 2 08-010P Rev A
- Public TitleSafety and Efficacy clinical trial of the PTMA System to reduce mitral valve regurgitation in heart failure.
- Scientific TitleA multi-center, open-label, single-arm study of the Safety and Efficacy of the Percutaneous TransvenOus Mitral AnnuloplastY System to Reduce Mitral Valve Regurgitation in Patients with Heart Failure.
- ACRONYMPTOLEMY 2
- hypothesisReduction of the severity of functional mitral regurgitation using a percutaneously delivered implanted device.
- Healt Condition(s) or Problem(s) studiedHeart failure, Mitral valve insufficiency, Mitral valve, Mitral regurgitation
- Inclusion criteria1. Moderate functional MR
2. Symptomatic heart failure
3. LV dysfunction (25% < LVEF < 50%)
4. Age >/= 50 years
- Exclusion criteria1. MR of organic origins
2. Severe mitral leaflet tethering
3. Not capable of walking 100 meters in 6 minutes
4. Existing bi-ventricular pacemaker with leads in the coronary sinus or its tributaries
5. Significant co-morbidities
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 30-okt-2008
- planned closingdate30-apr-2014
- Target number of participants30
- InterventionsSubject is screened and given baseline assessments.
Subject receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant.
- Primary outcome- Safety: freedom from MACE rate
- Efficacy: Quantitative MR reduction at 6 months and device success.
- Secondary outcome- Safety
- Efficacy
- TimepointsPost-Procedural follow-up up to 5 years.
- Trial web sitehttp://www.viacor.com
- statusopen: patient inclusion
- 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.
- Publicationshttp://www.viacorinc.com/bibliography.html
- Brief summaryPTOLEMY 2 - Multicenter onderzoek naar de veiligheid en doeltreffendheid van het percutane transveneuze mitrale annuloplastieksysteem gebruikt voor het reduceren van mitralisklepinsufficiŽntie bij patiŽnten met hartfalen.
- Main changes (audit trail)
- RECORD30-okt-2008 - 9-nov-2008


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