Clinical trial NCT02009696: ProMRI Study of the Entovis Pacemaker System (Phase B)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Magnetic Resonance Imaging (MRI); Cardiac Pacing
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-12
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients selected for participation should be from the investigators' general patient population according to the inclusion and exclusion criteria.

Brief summary: 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.


Eligibility criteria: 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
* 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

Primary outcomes:
measure: MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate
timeFrame: 1 Month Post-MRI
measure: Percentage of Participants Free of Atrial Pacing Threshold Rise
timeFrame: Between Pre-MRI and 1 Month Post-MRI
measure: Percentage of Participants Free of Ventricular Pacing Threshold Rise
timeFrame: Between Pre-MRI and 1 Month Post-MRI
measure: Percentage of Participants Free of P-wave Sensing Attenuation
timeFrame: Between Pre-MRI and 1 Month Post-MRI
measure: Percentage of Participants Free of R-wave Sensing Attenuation
timeFrame: Between Pre-MRI and 1 Month Post-MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Concord
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Newark
country: United States
state: Delaware
city: Washington
country: United States
state: District of Columbia
city: Valparaiso
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Lafayette
country: United States
state: Louisiana
city: Cumberland
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Burlington
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Ypsilanti
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Bronx
country: United States
state: New York
city: Flushing
country: United States
state: New York
city: New York
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Toledo
country: United States
state: Ohio
city: Salem
country: United States
state: Oregon
city: Newtown
country: United States
state: Pennsylvania
city: Greenville
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Amarillo
country: United States
state: Texas
city: Mechanicsville
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
Study officials:
References:
citation: Bailey WM, Mazur A, McCotter C, Woodard PK, Rosenthal L, Johnson W, Mela T; ProMRI Study Investigators. Clinical safety of the ProMRI pacemaker system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance imaging scanning conditions. Heart Rhythm. 2016 Feb;13(2):464-71. doi: 10.1016/j.hrthm.2015.09.021. Epub 2015 Sep 25.