ProMRI Study of the Entovis Pacemaker System (Phase B)

Completed

Conditions studied: Magnetic Resonance Imaging (MRI); Cardiac Pacing

In brief

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.

Key facts

Study ID

NCT02009696

Run by

Biotronik, Inc.

People needed

221

Starts

2013-12-01

Expected to finish

2015-01-01

Last updated by the study team

2015-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Concord, California, United States
• Study site — Newport Beach, California, United States
• Study site — Rancho Mirage, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — Newark, Delaware, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Valparaiso, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Lafayette, Louisiana, United States
• Study site — Cumberland, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Burlington, Massachusetts, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Ypsilanti, Michigan, United States
• Study site — Kansas City, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Flushing, New York, United States
• Study site — New York, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Toledo, Ohio, United States
• Study site — Salem, Oregon, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.