ProMRI PROVEN Master Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs

Intervention / Treatment
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* Device: ICD/CRT-P therapy
* Other: MRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICD/CRT-P therapy<br>Standard indication for ICD or triple-chamber pacemaker therapy | Device: ICD/CRT-P therapy<br> <br> * Other names: Protego ProMRI SD;Other: MRI<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICD therapy, CRT-P therapy, MRI