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OpenTrials
Completed

NCT Number: NCT02506569

ProMRI 3T ENHANCED Master Study

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 .

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Key information

Conditions

Safety of MR (Magnetic Resonance)-Conditional ICDs

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Flinders Medical Centre, Bedford Park, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantable Cardioverter Defibrillator therapy

Device

Tachycardia Fast Heart Beat

magnetic resonance imaging (MRI)

Other

MRI scan of the head and lower body parts

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 23, 2015
Registry last updated
Feb 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.