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Sponsored by: |
pfm Produkte fuer die Medizin AG |
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Information provided by: | pfm Produkte fuer die Medizin AG |
ClinicalTrials.gov Identifier: | NCT00390702 |
The Ventricular septal defect (VSD) is the most common of all congenital cardiac malformations. By modifying the Nit-Occlud® PDA Device the Nit-Occlud® Lê VSD Spiral System was designed. as a percutaneous, transcatheter device for occlusion of (peri)membranous and muscular ventricular septum defects (VSD) with a spiral coil. In this clinical investigation feasibility, safety and performance of the new cardiac occluder will be evaluated in accordance with European and US regulations. The study data will be compared to performance criteria for VSD, which are deduced analogue to the published specific Objective Performance Criteria (OPCs) for PDAs. The first part of the study has been performed in three clinical centres in Germany. For the second part in April 2009 four additional clinical centres in Germany, Israel, Italy and Spain were included.
Condition | Intervention | Phase |
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Heart Septal Defects, Ventricular |
Device: transcatheter implantation of a VSD occluder (Nitinol coil) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | International Multicentre Clinical Device Investigation on Safety and Effectiveness of the Nit-Occlud® Lê VSD Spiral Coil System for VSD Occlusion Developed by Pfm AG, Cologne |
Estimated Enrollment: | 338 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
VSD occluder: Experimental
transcatheter implantation of a VSD occluder (Nitinol coil)
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Device: transcatheter implantation of a VSD occluder (Nitinol coil)
transcatheter implantation, by first performing a arterial-venous loop through the defect
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Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pathological or physical condition precluding the implantation of a Nit-Occlud® Lê VSD coil, such as :
Contact: Hartmut Simon | +49-2236-9641-147 | hartmut.simon@pfm-ag.de |
Contact: Eike G. Fischer, Dr | +49-241-963-2550 | eike@aix-scientifics.com |
Germany | |
Dept. Paediatric Cardiology, Univ. Hospital Hamburg | Recruiting |
Hamburg, Germany, 20246 | |
Principal Investigator: Trong-Phi Lê, Dr. | |
Cardio-Vascular Centre, Sankt Kathrinen | Recruiting |
Frankfurt, Germany, 60389 | |
Principal Investigator: Horst Sievert, Prof Dr | |
Dept. Paediatric Cardiology, Univ. Clinic Grosshadern | Recruiting |
Munich, Germany, 81377 | |
Principal Investigator: Rainer Kozlik-Feldmann, Dr | |
Dept. Congem.Heart Defects, Deutsches Herzzentrum | Recruiting |
Berlin, Germany, 13353 | |
Contact: Peter Ewert, PD Dr.med. | |
Principal Investigator: Peter Ewert, PD Dr. | |
Univ.Klinikum, Zentrum fuer Kinderheilkunde | Not yet recruiting |
Giessen, Germany, 35390 | |
Contact: Dietmar Schranz, Prof. Dr. | |
Principal Investigator: Dietmar Schranz, Prof. Dr. | |
Israel | |
Meyer Children's Hospital, Rambam Med. Center | Not yet recruiting |
Haifa, Israel, 31096 | |
Contact: Avraham Lorber, Dr. med. | |
Principal Investigator: Avraham Lorber, Dr. | |
Italy, MI | |
IRCCS Policlinico San Donato, Dept. di Cardiol. ped. e Cardiopatie congen. | Not yet recruiting |
San Donato milanese, MI, Italy, 20097 | |
Contact: Mario Carminati, Prof. Dr. | |
Principal Investigator: Mario Carminati, Prof. Dr. | |
Spain | |
Hospital Gen.Univ. Gregorio Maranoin, Serv. Hemodin. Infantil | Not yet recruiting |
Madrid, Spain, 28007 | |
Contact: José L Zunzunegui, Dr. | |
Principal Investigator: José L Zunzunegui, Dr. |
Principal Investigator: | Thomas Meinertz, Prof Dr med | University Hospital Hamburg Eppendorf, Germany |
Responsible Party: | pfm Produkte fuer die Medizin AG ( Hartmut Simon ) |
Study ID Numbers: | pfm 01/2005 |
Study First Received: | October 19, 2006 |
Last Updated: | April 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00390702 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Ventricular septal defect VSD |
Heart Septal Defects Heart Diseases Cardiovascular Abnormalities Heart Septal Defects, Ventricular |
Ventricular Septal Defects Congenital Heart Septum Defect Congenital Abnormalities Heart Defects, Congenital |
Heart Septal Defects Heart Diseases Cardiovascular Abnormalities Heart Septal Defects, Ventricular |
Cardiovascular Diseases Congenital Abnormalities Heart Defects, Congenital |