Clinical trial NCT01761162: ProMRI Study of the Entovis Pacemaker System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Safety of the ProMRI Pacemaker System Under Specific MRI Conditions
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-04
Enrollment: 229
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 is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions.


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
* 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

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: Pre-MRI, 1 Month Post-MRI
measure: Percentage of Participants Free of Ventricular Pacing Threshold Rise
timeFrame: Pre-MRI, 1 Month Post-MRI
measure: Percentage of Participants Free of P-wave Sensing Attenuation
timeFrame: Pre-MRI, 1 Month Post-MRI
measure: Percentage of Participants Free of R-wave Sensing Attenuation
timeFrame: Pre-MRI, 1 Month Post-MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Arrhythmia Consultants
state: Arizona
city: Concord
country: United States
facility: John Muir Medical Center
state: California
city: Newport Beach
country: United States
facility: Hoag Hospital
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: New Haven
country: United States
facility: Yale - New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Valparaiso
country: United States
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Lafayette
country: United States
facility: Louisiana Heart Rhythm Specialists
state: Louisiana
city: Cumberland
country: United States
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Burlington
country: United States
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Ypsilanti
country: United States
facility: Saint Joseph Mercy Medical Center
state: Michigan
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Camden
country: United States
state: New Jersey
city: Flushing
country: United States
facility: New York Hospital Queens
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
facility: Toledo Hospital
state: Ohio
city: Langhorne
country: United States
facility: Saint Mary Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Greenville
country: United States
state: South Carolina
city: Richmond
country: United States
state: Virginia
Study officials:
References:
citation: Bailey WM, Rosenthal L, Fananapazir L, Gleva M, Mazur A, Rinaldi CA, Kypta A, Merkely B, Woodard PK; ProMRI/ProMRI AFFIRM Study Investigators. Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions. Heart Rhythm. 2015 Jun;12(6):1183-91. doi: 10.1016/j.hrthm.2015.02.010. Epub 2015 Feb 11.