Clinical trials: Cardiac MRI
Magnetic Resonance Imaging (MRI); Cardiac Pacing
ProMRI Study of the Entovis Pacemaker System (Phase B)
The objective of the ProMRI Study (Phase B) is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions without scan exclusion zone.
- Trial name
- NCT02009696
- Testing
- Patients with a ProMRI Pacemaker System, Magnetic Resonance Imaging (MRI) scan
- Where
- 32 sites in United States
- Volunteers
- 221 people
- Sponsor
- Biotronik, Inc.
Magnetic Resonance Imaging (MRI), Cardiac Pacing
Evaluation of Approved Pacing Lead (Model 5076) for Use in MRI Environment
The purpose of this study is to test the safety and effectiveness of the Medtronic CapSureFix Novus Model 5076 lead when patients are implanted with the Medtronic Advisa MRI pacemaker and undergo an MRI scan.
- Trial name
- NCT01755143
- Testing
- Magnetic Resonance Imaging scan sequences of the head, neck, and chest, Pacemaker System
- Where
- 36 sites in Australia, Austria and 17 more
- Volunteers
- 266 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure