EMRI SureScan™ Clinical Study

Medtronic

Status: Completed

Conditions: Bradycardia; Slow Heart Beat

Treatments: Other: Magnetic Resonance Imaging (MRI) scan; Device: Implantable Pulse Generator (IPG) and Pacing Leads (wires)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00433654

212

Details and patient eligibility

About

The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing System (used in support of Revo MRI™ SureScan Pacing System launch).

Full description

This study is a prospective, multi-center global study.

Enrollment: 484 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has, or is at risk of having, a heart beat that is too slow and his/her doctor has determined he/she needs a pacemaker.
• Subject available for follow-up at study center for length of study.
• Subject able and willing to undergo elective MRI scanning without sedation.

Exclusion criteria

• Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD).
• Subject needs or will need another MRI-scan, other than those required by the study, during the required study follow-up period.
• Pregnant women, or women of child bearing potential who are not on a reliable form of birth control.
• Subject with exclusion criteria required by local law.
• Subject who intends to participate in another clinical study during this clinical study.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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484 participants in 2 patient groups

MRI group

Active Comparator group

Description:

The MRI group underwent a one-hour MRI scan at the 9-12 weeks post-implant follow-up.

Treatment:

Device: Implantable Pulse Generator (IPG) and Pacing Leads (wires)

Other: Magnetic Resonance Imaging (MRI) scan

Control group

Other group

Description:

The control group waited for one hour (no MRI) at the 9-12 weeks post-implant follow-up.

Treatment:

Device: Implantable Pulse Generator (IPG) and Pacing Leads (wires)