ProMRI Study of the Entovis Pacemaker System

Completed

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

In brief

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

Key facts

Study ID

NCT01761162

Run by

Biotronik, Inc.

People needed

229

Starts

2013-02-01

Expected to finish

2014-05-01

Last updated by the study team

2017-02-09

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
• 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

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

• Arizona Arrhythmia Consultants — Scottsdale, Arizona, United States
• John Muir Medical Center — Concord, California, 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
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Study site — Valparaiso, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Louisiana Heart Rhythm Specialists — Lafayette, Louisiana, United States
• Study site — Cumberland, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Study site — Burlington, Massachusetts, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Saint Joseph Mercy Medical Center — Ypsilanti, Michigan, United States
• Research Medical Center — Kansas City, Missouri, United States
• Washington University — St Louis, Missouri, United States
• Study site — Camden, New Jersey, United States
• New York Hospital Queens — Flushing, New York, United States
• Study site — New York, New York, United States
• Study site — Winston-Salem, North Carolina, United States
• Toledo Hospital — Toledo, Ohio, United States
• Saint Mary Medical Center — Langhorne, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Study site — Greenville, South Carolina, United States
• Study site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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