Safety and Effectiveness of the Nit-Occlud® Lê VSD Spiral Coil System

Condition(s) targeted: Heart Septal Defects, Ventricular

Intervention: transcatheter implantation of a VSD occluder (Nitinol coil) (Device)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: pfm Produkte fuer die Medizin AG

Official(s) and/or principal investigator(s):
Thomas Meinertz, Prof Dr med, Principal Investigator, Affiliation: University Hospital Hamburg Eppendorf, Germany

Overall contact:
Hartmut Simon, Phone: +49-2236-9641-147, Email: hartmut.simon@pfm-ag.de

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.

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

Study design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: a set of Performance Criteria (PC) deduced for VSD analogue to the set of Objective Performance Criteria (OPC) of the 'Multiorganization Advisory Panel to FDA for Pediatric Cardiovascular Devices' for PDAs

Secondary outcome: -- as a set of Performance Criteria is used, no additional sec. endpoints are defined. --

Minimum age: 2 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- VSD must be diagnosed by acknowledged methods, like echocardiography

- Signs of left ventricular volume overload are present (left ventricle or left atrium

diameters 2 standard deviations greater than normal) and/or measured by catheterisation : Qp/Qs > 1. 5

- Pulmonary vascular resistance is less than 4 Wood units

- The patient is older than 24 months

- The VSD has a perimembranous or muscular location.

- A distance between the rim of the VSD and the aortic annulus of at least 3. 0 mm (as

measured on the 2-D echocardiography - apical 5-chamber view)

- The minimal diameter (size) of the VSD is less than 8. 0 mm (as measured on the 2-D

echocardiography - apical 5-chamber view)

- Patient must agree to fully participate in the clinical trial and give informed

consent in writing. If the patient is without legal ability additionally the person of legal responsibility must agree and s/he must give the informed consent in writing

Exclusion Criteria:

Pathological or physical condition precluding the implantation of a Nit-Occlud® Lê VSD coil, such as :

- perimembranous VSD with no evidence of circular aneurysm formation

- Associated cardiac anomalies requiring surgery (greater than mild aortic

insufficiency; such as aortic valve prolapse)

- Active endocarditis or other type of sepsis or other active infection at time of

implantation

- Thrombus at or near the intended site of implantation

- Thrombus in the vessels through which access to the VSD is gained (unless the patient

is protected with an embolic protection device such as a vena cava filter)

- Vessels through which access to the VSD is gained can not accommodate a 7 F sheath

- Potential steric (3-dimensional) interference of the occluder with intracardiac or

intravascular structures (like valves)

- History of blood disorder (coagulopathy, tendency towards haemolysis)

- History of hypersensitivity to contrast medium or Nitinol

- AV-block II° or III°, atrial fibrillation, or atrial flutter

- End stage cardiac disease, irreversible major organ failure, or terminal cancer

- HIV infection

- Cerebrovascular disease or neurological deterioration

- Emergency cardiologic intervention

- Patient*) is not able to fully participate in this study including all follow-ups

(e. g. for mental or geographical reasons, or patient is intravenous drug user or has strong potential for non-compliance to medical regimes)

- Patient, respectively the person of legal responsibility, is mentally unable to

understand the nature, aims, or possible consequences of the clinical investigation

- Pregnant or breast-feeding women

- Patient did participate in another clinical investigation during the last 3 months

- Patient or the person of responsibility has revoked the consent.

Hartmut Simon, Phone: +49-2236-9641-147, Email: hartmut.simon@pfm-ag.de

Dept. Paediatric Cardiology, Univ. Hospital Hamburg, Hamburg 20246, Germany; Recruiting
Trong-Phi Lê, Dr., Principal Investigator

Cardio-Vascular Centre, Sankt Kathrinen, Frankfurt 60389, Germany; Recruiting
Horst Sievert, Prof Dr, Principal Investigator

Dept. Paediatric Cardiology, Univ. Clinic Grosshadern, Munich 81377, Germany; Recruiting
Rainer Kozlik-Feldmann, Dr, Principal Investigator

Dept. Congem.Heart Defects, Deutsches Herzzentrum, Berlin 13353, Germany; Recruiting
Peter Ewert, PD Dr.med.
Peter Ewert, PD Dr., Principal Investigator

Univ.Klinikum, Zentrum fuer Kinderheilkunde, Giessen 35390, Germany; Not yet recruiting
Dietmar Schranz, Prof. Dr.
Dietmar Schranz, Prof. Dr., Principal Investigator

Meyer Children's Hospital, Rambam Med. Center, Haifa 31096, Israel; Recruiting
Avraham Lorber, Dr. med.
Avraham Lorber, Dr., Principal Investigator

Hospital Gen.Univ. Gregorio Maranoin, Serv. Hemodin. Infantil, Madrid 28007, Spain; Not yet recruiting
José L Zunzunegui, Dr.
José L Zunzunegui, Dr., Principal Investigator

IRCCS Policlinico San Donato, Dept. di Cardiol. ped. e Cardiopatie congen., San Donato milanese, MI 20097, Italy; Not yet recruiting
Mario Carminati, Prof. Dr.
Mario Carminati, Prof. Dr., Principal Investigator

Starting date: October 2006
Ending date: December 2012
Last updated: July 15, 2009