ProMRI 3T ENHANCED Master Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

129 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-01-15

Brief Summary

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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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Detailed Description

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Conditions

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Safety of MR (Magnetic Resonance)-Conditional ICDs

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Implantable Cardioverter Defibrillator therapy

Tachycardia Fast Heart Beat

Intervention Type DEVICE

Magnetic Resonance Imaging (MRI)

MRI scan of the head and lower body parts

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No