ProMRI Study of the Entovis Pacemaker System

Completed

Conditions: Safety of the ProMRI Pacemaker System Under Specific MRI Conditions

Interventions: Device: Patients with a ProMRI Pacemaker System
Other: Magnetic Resonance Imaging (MRI) scan

Brief Summary: The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions.

Recruitment & Eligibility

Inclusion Criteria

The following initial inclusion criteria must be met for a subject to be enrolled and considered for the MRI-procedure:

Age greater than 18 years
Subject body height greater than 140 cm (4' 7")
Able and willing to complete MRI testing
Able to provide written informed consent
Available for follow-up visit at the study site
Implanted with a pacemaker system consisting only of an Entovis pacemaker (DR-T, SR-T) and one or two Setrox S 53 or Setrox S 60 pacemaker lead(s). (No leads other than Setrox S (53 or 60 cm) leads may be implanted. This includes lead extensions or abandoned leads in the subject.)
Pacemaker implanted pectorally
All pacemaker system components implanted, repositioned, or exchanged at least 5 weeks prior to enrollment
Underling rhythm identifiable during sensing test
All pacing thresholds are measureable and are less than or equal to 2.0 V @0.4 ms
Absence of phrenic nerve stimulation at 4.8V @ 1.0 ms
Pacing impedance is between 200 and 1500 ohm
Able and willing to use the Cardio Messenger

At the pre-MRI procedure, the following procedure-related criteria must be met for the subject to undergo the MRI scan:

Absence of phrenic nerve stimulation at 4.8V @ 1.0 ms
|pacing threshold at Pre-MRI follow-up - pacing threshold at baseline| ≤ 0.5 V
All pacing thresholds are measureable and are ≤ 2.0 V @ 0.4 ms
The pacemaker system has been implanted for at least 6 weeks.
Subject did not have a pacemaker or lead explant, exchange or reposition in the previous 6 weeks.
All lead impedances are between 200 and 1500 ohm.
Battery status is at least 30% of capacity

Exclusion Criteria

Enrolled in any other clinical study
For pacemaker systems that include an atrial lead, subjects with either
- Persistent atrial arrhythmia (lasting longer than 7 days or requiring cardioversion)
- Permanent atrial arrhythmia
Life expectancy of less than three months
Pregnancy
Cardiac surgery expected in the next three months
Implanted with other medical devices that may interact with MRI, such as:
- abandoned pacemaker/ICD leads
- lead extensions
- mechanical valves
- other active medical devices
- non-MRI compatible devices
- other metallic artifacts/components in body that may interact with MRI

Arm && Interventions

Group	Intervention	Description
Pacemaker Therapy	Patients with a ProMRI Pacemaker System	Patients with a ProMRI Pacemaker System
Pacemaker Therapy	Magnetic Resonance Imaging (MRI) scan	Patients with a ProMRI Pacemaker System

Primary Outcome Measures

Name	Time	Method
MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate	1 Month Post-MRI
Percentage of Participants Free of Ventricular Pacing Threshold Rise	Pre-MRI, 1 Month Post-MRI	Evaluate the percentage of ventricular pacing leads free of pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.
Percentage of Participants Free of R-wave Sensing Attenuation	Pre-MRI, 1 Month Post-MRI	Evaluate the percentage of subjects free of R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.
Percentage of Participants Free of Atrial Pacing Threshold Rise	Pre-MRI, 1 Month Post-MRI	Evaluate the percentage of atrial pacing leads free of pacing threshold increase between the pre-MRI and one-month post-MRI follow-up.
Percentage of Participants Free of P-wave Sensing Attenuation	Pre-MRI, 1 Month Post-MRI	Evaluate the percentage of subjects free of P-wave attenuation between the pre-MRI and one-month post-MRI follow-up.

Secondary Outcome Measures

Name	Time	Method

Locations (17): John Muir Medical Center
🇺🇸
Concord, California, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
University of Massachusetts Medical School
🇺🇸
Worcester, Massachusetts, United States
Arizona Arrhythmia Consultants
🇺🇸
Scottsdale, Arizona, United States
Saint Mary Medical Center
🇺🇸
Langhorne, Pennsylvania, United States
Research Medical Center
🇺🇸
Kansas City, Missouri, United States
Saint Joseph Mercy Medical Center
🇺🇸
Ypsilanti, Michigan, United States
Hoag Hospital
🇺🇸
Newport Beach, California, United States
Eisenhower Medical Center
🇺🇸
Rancho Mirage, California, United States
Yale - New Haven Hospital
🇺🇸
New Haven, Connecticut, United States
University of Iowa Hospitals and Clinics
🇺🇸
Iowa City, Iowa, United States
Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Louisiana Heart Rhythm Specialists
🇺🇸
Lafayette, Louisiana, United States
Washington University
🇺🇸
Saint Louis, Missouri, United States
New York Hospital Queens
🇺🇸
Flushing, New York, United States
Toledo Hospital
🇺🇸
Toledo, Ohio, United States
Rhode Island Hospital
🇺🇸
Providence, Rhode Island, United States