ProMRI AFFIRM Study of the EVIA/ENTOVIS Pacemaker With Safio S Pacemaker Leads

Study Overview
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Brief Summary
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This investigation is designed to demonstrate the clinical safety of the EVIA/ ENTOVIS pacemaker system when used under specific MRI conditions.

Detailed Description
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In the past, MR scans were always contraindicated for pacemaker patients. If particular prerequisites and conditions are fulfilled, MR scans can now be conducted on patients with BIOTRONIK's EVIA/ENTOVIS pacemakers in combination with the Safio S pacemaker leads, scheduled to be part of this clinical study. The specific MRI conditions for this investigation with the EVIA/ENTOVIS pacemaker family and Safio S pacemaker leads are defined in the study protocol

Official Title
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Master Study for the MRI Compatibility of the EVIA/ENTOVIS Pacemaker in Combination With Safio S Pacemaker Lead

Conditions
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Cardiac Disease

Intervention / Treatment
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* Procedure: Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pacemaker system consisting solely of the EVIA/ENTOVIS pacemaker and Safio S pacemaker leads The pacemaker system has to be implanted, repositioned or exchanged at least 5 weeks prior to enrollment Age more than 18 years Understand the nature of the procedure Able and willing to complete MRI testing Able and willing to activate and use the Cardio Messenger Give written informed consent Able to complete all testing required by the clinical protocol Ability to measure atrial and/or ventricular pacing threshold(s)* (at 0.4 ms) All pacing thresholds do not exceed 2.0V @0.4ms. Available for follow-up visit at the investigational site Patient body height greater or equal to 140 cm Pectoral implantation The ascertained lead impedance is between 200 and 1500 Ohms. Exclusion Criteria: No EVIA/ENTOVIS /Safio S pacemaker system implanted Pacing threshold(s) (at 0.4 ms) and sensing amplitudes are not measurable Meet one or more of the contraindications Being pregnant Have a life expectancy of less than three months Cardiac surgery already scheduled in the next three months Enrolled in another cardiac clinical investigation Have other medical implants that may interact with MRI, e.g. abandoned pacemaker/ICD leads, lead extensions, other active medical devices, non-MRI compatible devices (e.g. mechanical tricuspid valve) Have other metallic artifacts/components in body that may interact with MRI

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 |
| --- | --- |
| Pacemaker therapy<br>Patients with an EVIA/ ENTOVIS pacemaker device. See inclusion and exclusion criteria. | Procedure: Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions<br>* patients will undergo an MRI scan for 30 minutes.<br>* Other names: Safio S 45;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary hypothesis 1: MRI and pacing system related Serious Adverse Device Effect (SADE) free rate | MRI and pacing system related Serious Adverse Device Effect (SADE) Free-Rate is greater than 90%. | 3 months | 
| Primary hypotheses 2 and 3: pacing threshold rise (atrial and ventricular) | The atrial or ventricular MRI induced pacing threshold rise is not larger than or equal to 0.5 V between Pre-MRI and 1-month follow-up | 1 month | 
| Primary hypothesis 4: P-wave sensing attenuation | P-wave attenuation: P-wave amplitude decrease (between pre-MRI follow-up and 1-month follow-up) exceeding 50% or a P-wave amplitude at 1-month follow-up smaller or equal to 1.5 mV | 1 month | 
| Primary hypothesis 5: R-wave sensing attenuation | R-wave attenuation: R-wave amplitude decrease (between pre-MRI follow-up and 1-month follow-up) exceeding 50% or a R-wave amplitude at 1-month follow-up smaller or equal to 5.0 mV. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pacemaker therapy, Magnetic Resonance Imaging (MRI), EVIA/ENTOVIS