ProMRI PROVEN Master 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

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.

Study Overview

• Status: Completed
• Conditions: Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs
• Intervention / Treatment: Other: MRI; Device: ICD/CRT-P therapy

• Study Type: Observational
• Enrollment (Actual): 174

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia
    • Royal Adelaide Hospital
  • Perth, Australia
    • Royal Perth Hospital
  • Sydney, Australia
    • Royal North Shore Hospital
  • New South Wales
    • Camperdown, New South Wales, Australia
      • Royal Prince Alfred Hospital
  • South Australia
    • Bedford Park, South Australia, Australia
      • Flinders Medical Center
  • Victoria
    • Box Hill, Victoria, Australia
      • Box Hill Hospital
• Austria
  • Linz, Austria
    • AKh Linz
  • St. Poelten, Austria, 3100
    • Landesklinikum St. Pölten
• Canada
  • Edmonton, Canada
    • Royal Alexandra Hospital
  • Ontario
    • Toronto, Ontario, Canada
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada
      • Toronto General Hospital
  • Quebec
    • Montreal, Quebec, Canada
      • Montreal Heart Institute
    • Sherbrooke, Quebec, Canada
      • CHUS - Centre hospitalier universitaire de Sherbrooke
• Czech Republic
  • Olomouc, Czech Republic
    • University Hospital Olomouc
• France
  • Brest, France
    • CHU Brest
  • Tours, France
    • CHRU de Tours - Hôpital Trousseau
• Germany
  • Bonn, Germany, 53105
    • Universitätsklinikum Bonn
  • Coburg, Germany
    • Klinikum Coburg
  • Essen, Germany, 45138
    • Elisabeth Krankenhaus Essen
  • Villingen Schwenningen, Germany, 78050
    • Schwarzwald Baar Klinikum Villingen Schwenningen
  • Würzburg, Germany, 97080
    • Medizinische Universitätsklinik Würzburg
• Hungary
  • Budapest, Hungary, 1122
    • Semmelweis University
• Switzerland
  • Zürich, Switzerland
    • Stadtspital Triemli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ICD/CRT-P therapy; Standard indication for ICD or triple-chamber pacemaker therapy	Other: MRI; Device: ICD/CRT-P therapy; Other Names: Ilesto 7/5; Iforia 7/5; Evia HF-T; Entovis HF-T; Solia S; Solia T; Linoxsmart ProMRI S, SD or S DX; Linoxsmart ProMRI DF4 SD; Corox ProMRI OTW BP, -S BP or -L BP; Protego ProMRI SD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Serious Adverse Device Effect (SADE) -free rate of the ICD/CRT-P system related to MRI	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	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.	pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG
• Investigators: Principal Investigator: Wolfgang R. Bauer, Prof.Dr.Dr., Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I, Oberdürrbacher Str. 6, 97080 Würzburg, Germany

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: March 12, 2013
• First Submitted That Met QC Criteria: March 12, 2013
• First Posted (Estimate): March 13, 2013

Study Record Updates

• Last Update Posted (Estimate): March 2, 2016
• Last Update Submitted That Met QC Criteria: March 1, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: MRI; ICD therapy; CRT-P therapy
• Other Study ID Numbers: 61