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

Biotronik

Status: Completed

Conditions: Cardiac Disease

Treatments: Procedure: Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions

Study type: Observational

Funder types: Industry

Identifiers

NCT01460992

49

Details and patient eligibility

About

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

Full 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

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

121 participants in 1 patient group

Pacemaker therapy

Description:

Patients with an EVIA/ ENTOVIS pacemaker device. See inclusion and exclusion criteria.

Treatment:

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