ProMRI 3T ENHANCED Master Study

February 6, 2018 updated by: Biotronik SE & Co. KG
The investigation is designed to provide supporting evidence for the clinical safety of the Biotronik's new Implantable Cardioverter Defibrillator systems when used under specific 3 Tesla MR conditions .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

129

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

  • Australia
      • Bedford Park, Australia
        • Flinders Medical Centre
      • Sydney, Australia
        • Royal North Shore Hospital
      • Westmead, Australia
        • Westmead Hospital
  • Austria
      • Linz, Austria
        • Allgemeines Krankenhaus Linz
      • St. Pölten, Austria
        • Landesklinikum St. Pölten
  • Germany
      • Berlin, Germany
        • Deutsches Herzzentrum Berlin
      • Coburg, Germany
        • Klinikum Coburg
      • Düsseldorf, Germany
        • Uniklinikum Düsseldorf
      • Göttingen, Germany
        • Universitätsklinikum Göttingen
      • Lingen, Germany
        • St. Bonifatius Hospital
  • Singapore
      • Singapore, Singapore
        • National Heart Centre
  • Switzerland
      • Zürich, Switzerland
        • Stadtspital Triemli

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The patients selected for participation should be from the investigator's general patient population according to the inclusion and exclusion criteria.

Description

Inclusion Criteria:

  • Implanted with Implantable Cardioverter Defibrillator (ICD) system according to Clinical Investigational Plan (CIP)
  • ICD system was implanted in the pectoral region
  • Implantation at least 5 weeks prior to enrollment date
  • Patient body height ≥ 140 cm
  • Age ≥ 18 years
  • Right Ventricular pacing threshold (at 0.4 ms) measurable and ≤ 2.0 V
  • Written informed consent
  • Able and willing to complete MRI testing
  • Able and willing to complete all testing required by the clinical protocol
  • Available for all follow-up visits at the investigational site

Exclusion Criteria:

  • Standard contraindication for MRI scans
  • Patient shows signs of a twiddler's syndrome, i.e. fiddles with implant
  • Explantation, exchange or reposition of ICD or lead within 5 weeks prior to enrollment date
  • Charging status of the battery is Elective Replacement Indicator (ERI) or End of Service (EOS)
  • MRI scan within 5 weeks prior to enrollment date
  • R-wave sensing amplitude < 6.5 millivolt
  • Lead impedance less than 200 or greater than 1500 Ohm
  • Life expectancy of less than six months
  • Cardiac surgery in the next six months
  • Pregnant or breastfeeding
  • Participation in another interventional clinical investigation

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious Adverse Device Effect (SADE)-free rate of implantable cardioverter defibrillators and leads possibly or securely related to the MRI procedure
Time Frame: 1 Month
1 Month
Increase in pacing thresholds ratios measured between 1-month post-MRI and pre-MRI
Time Frame: 1 Month
Evaluate the percentage of ICD leads with an increase in the pacing threshold ratio measured between the Pre-MRI and 1-month post-MRI
1 Month
Decrease in sensing amplitude ratios between 1-month post-MRI and pre-MRI
Time Frame: 1 Month
Evaluate the percentage of ICD leads with a decrease in the sensing amplitude ratio measured between the Pre-MRI and 1-month post-MRI
1 Month

Collaborators and Investigators

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

Sponsor

Biotronik SE & Co. KG

Investigators

  • Principal Investigator: Rainer Zbinden, Dr., Triemli Hospital

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

January 1, 2015

Primary Completion (Actual)

January 15, 2018

Study Completion (Actual)

January 15, 2018

Study Registration Dates

First Submitted

July 14, 2015

First Submitted That Met QC Criteria

July 22, 2015

First Posted (Estimate)

July 23, 2015

Study Record Updates

Last Update Posted (Actual)

February 7, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • TA109

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.

Clinical Trials on Safety of MR (Magnetic Resonance)-Conditional ICDs

Clinical Trials on Implantable Cardioverter Defibrillator therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe