ProMRI PROVEN Master Study

Overview

This investigation is designed to provide supporting evidence for the clinical safety of the Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T (Heart Failure) triple chamber pacemaker system when used under specific MRI (magnetic resonance imaging) conditions.

Full Title of Study: “Master Study for the MRI Compatibility of the Solia S and Solia T Pacing Lead, the Linoxsmart ProMRI and Linoxsmart ProMRI DF4 ICD (Implantable Cardioverter-defibrillator) Lead and the Corox ProMRI OTW Coronary Sinus Lead in Combination With the Ilesto/Iforia ICD or the Evia/Entovis Triple Chamber Pacemaker”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2015

Interventions

  • Device: ICD/CRT-P therapy
  • Other: MRI

Arms, Groups and Cohorts

  • ICD/CRT-P therapy
    • Standard indication for ICD or triple-chamber pacemaker therapy

Clinical Trial Outcome Measures

Primary Measures

  • The Serious Adverse Device Effect (SADE) -free rate of the ICD/CRT-P system related to MRI
    • Time Frame: pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI
  • Increase in atrial and ventricular pacing threshold(s) between pre-MRI and 1-month post-MRI
    • Time Frame: pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI
  • Decrease in P-wave and R-wave amplitude (right and left) between pre-MRI and 1-month post-MRI.
    • Time Frame: pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI

Participating in This Clinical Trial

Inclusion Criteria

  • Written informed consent – Able and willing to complete MRI testing – Able and willing to activate and use the Cardio Messenger – Able and willing to complete all testing required by the clinical protocol – Available for all follow-up visits at the investigational site – Standard indication for single, dual, or triple chamber ICD or CRT-P. – ICD or CRT-P system to be implanted in the pectoral region – Patient body height ≥ 140 cm – Age ≥ 18 years Exclusion Criteria:

  • Standard contraindication for single, dual, or triple chamber ICD or CRT-P. – Systems with an atrial lead: The patient has persistent (lasting longer than 7 days or requiring cardioversion) or permanent atrial arrhythmia – Patient has other medical implants that may interact with MRI, e.g. abandoned pacemaker/ICD leads, lead extensions, mechanical valves, other active medical devices, non-MRI compatible devices – Patient has other metallic artifacts / components in body that may interact with MRI – Life expectancy of less than eight months – Cardiac surgery in the next eight months – Pregnant or breastfeeding – Enrolled in another non-observational cardiac clinical investigation

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Biotronik SE & Co. KG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Wolfgang R. Bauer, Prof.Dr.Dr., Principal Investigator, Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I, Oberdürrbacher Str. 6, 97080 Würzburg, Germany

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