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ProMRI Study of the Entovis Pacemaker System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01761162
Recruitment Status : Completed
First Posted : January 4, 2013
Results First Posted : November 4, 2014
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Safety of the ProMRI Pacemaker System Under Specific MRI Conditions Device: Patients with a ProMRI Pacemaker System Other: Magnetic Resonance Imaging (MRI) scan

Study Design
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Study Type : Observational
Actual Enrollment : 229 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : February 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 2014
Groups and Cohorts
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Group/Cohort Intervention/treatment
Pacemaker Therapy
Patients with a ProMRI Pacemaker System
 Device: Patients with a ProMRI Pacemaker System
Bradycardia Slow Heart Beat

Other: Magnetic Resonance Imaging (MRI) scan
MRI scan of head and lower back.


Outcome Measures
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Primary Outcome Measures :
  1. MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate [ Time Frame: 1 Month Post-MRI ]
  2. Percentage of Participants Free of Atrial Pacing Threshold Rise [ Time Frame: 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.

  3. Percentage of Participants Free of Ventricular Pacing Threshold Rise [ Time Frame: 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.

  4. Percentage of Participants Free of P-wave Sensing Attenuation [ Time Frame: 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.

  5. Percentage of Participants Free of R-wave Sensing Attenuation [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761162


Locations
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Sponsors and Collaborators
Biotronik, Inc.
More Information
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Publications of Results:

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Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT01761162    
Other Study ID Numbers: G120226
First Posted: January 4, 2013    Key Record Dates
Results First Posted: November 4, 2014
Last Update Posted: February 9, 2017
Last Verified: December 2016