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

Completed

• Conditions: Cardiac Disease
• Interventions: Procedure: Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions

• Registration Number: NCT01460992
• Lead Sponsor: Biotronik SE & Co. KG

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2011-10-26
• Study First Posted: 2011-10-27
• Study Start: 2012-03
• Primary Completion: 2013-10
• Status Verified: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-27
• Last Update Posted: 2013-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pacemaker therapy	Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions	Patients with an EVIA/ ENTOVIS pacemaker device. See inclusion and exclusion criteria.

Primary Outcome Measures

Name	Time	Method
Primary hypotheses 2 and 3: pacing threshold rise (atrial and ventricular)	1 month	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
Primary hypothesis 5: R-wave sensing attenuation	1 month	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.
Primary hypothesis 4: P-wave sensing attenuation	1 month	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
Primary hypothesis 1: MRI and pacing system related Serious Adverse Device Effect (SADE) free rate	3 months	MRI and pacing system related Serious Adverse Device Effect (SADE) Free-Rate is greater than 90%.

Trial Locations

Locations (9)

St. Gertrauden Krankenhaus; 🇩🇪 Berlin, Germany

Allgemeines Krankenhaus Linz; 🇦🇹 Linz, Austria

Uniklinik Leipzig; 🇩🇪 Leipzig, Germany

DRK Krankenhaus Neuwied; 🇩🇪 Neuwied, Germany

Stadtspital Triemli; 🇨🇭 Zürich, Switzerland

University Hospital Olomouc; 🇨🇿 Olomouc, Czech Republic

Städtisches Klinikum Dresden-Friedrichstadt; 🇩🇪 Dresden, Germany

Cardiology Department, St Thomas' Hospital; 🇬🇧 London, United Kingdom

Diakoniekrankenhaus Mannheim; 🇩🇪 Mannheim, Germany