Safety and Effectiveness of the Nit-Occlud® Lê VSD Spiral Coil System (pfm-01/2005)

November 5, 2018 updated by: pfm medical ag

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Dept. Congem.Heart Defects, Deutsches Herzzentrum
      • Frankfurt, Germany, 60389
        • Cardio-Vascular Centre, Sankt Kathrinen
      • Giessen, Germany, 35390
        • Univ.Klinikum, Zentrum fuer Kinderheilkunde
      • Hamburg, Germany, 20246
        • Dept. Paediatric Cardiology, Univ. Hospital Hamburg
      • Munich, Germany, 81377
        • Dept. Paediatric Cardiology, Univ. Clinic Grosshadern
  • Israel
      • Haifa, Israel, 31096
        • Meyer Children's Hospital, Rambam Med. Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: VSD occluder
transcatheter implantation of a VSD occluder (Nitinol coil)
Device: transcatheter implantation of a VSD occluder (Nitinol coil)
transcatheter implantation, by first performing a arterial-venous loop through the defect
Other Names:
  • Nit-Occlud® Lê VSD Occluder

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Time Frame: Five years
Five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
pfm medical ag

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aix Scientifics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Meinertz, Prof Dr med, University Hospital Hamburg Eppendorf, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2006

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2006

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2006

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • pfm 01/2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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