ProMRI 3T ENHANCED Master Study

Completed

• Conditions: Safety of MR (Magnetic Resonance)-Conditional ICDs

• Registration Number: NCT02506569
• Lead Sponsor: Biotronik SE & Co. KG

Brief Summary

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-07-14
• Study First Submitted QC: 2015-07-22
• Study First Posted: 2015-07-23
• Primary Completion: 2018-01-15
• Study Completion: 2018-01-15
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-06
• Last Update Posted: 2018-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decrease in sensing amplitude ratios between 1-month post-MRI and pre-MRI	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
Increase in pacing thresholds ratios measured between 1-month post-MRI and pre-MRI	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
Serious Adverse Device Effect (SADE)-free rate of implantable cardioverter defibrillators and leads possibly or securely related to the MRI procedure	1 Month

Trial Locations

Locations (12)

Flinders Medical Centre; 🇦🇺 Bedford Park, Australia

Uniklinikum Düsseldorf; 🇩🇪 Düsseldorf, Germany

Westmead Hospital; 🇦🇺 Westmead, Australia

Klinikum Coburg; 🇩🇪 Coburg, Germany

Universitätsklinikum Göttingen; 🇩🇪 Göttingen, Germany

Royal North Shore Hospital; 🇦🇺 Sydney, Australia

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany

St. Bonifatius Hospital; 🇩🇪 Lingen, Germany

Landesklinikum St. Pölten; 🇦🇹 St. Pölten, Austria

National Heart Centre; 🇸🇬 Singapore, Singapore

Allgemeines Krankenhaus Linz; 🇦🇹 Linz, Austria

Stadtspital Triemli; 🇨🇭 Zürich, Switzerland