ProMRI Study of the Entovis Pacemaker System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.
ClinicalTrials.gov Identifier:
NCT01761162
First received: January 2, 2013
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Clinical Safety of the ProMRI Pacemaker System When Used Under Specific MRI Conditions.
Device: Patients with a ProMRI Pacemaker System
Other: Magnetic Resonance Imaging (MRI) scan

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Biotronik, Inc.:

Primary Outcome Measures:
  • MRI and pacing system related Serious Adverse Device Effect (SADE) free rate [ Time Frame: 1 Month ] [ Designated as safety issue: Yes ]
  • Atrial Pacing Threshold Rise [ Time Frame: 1 Month ] [ Designated as safety issue: Yes ]
    Evaluate the percentage of atrial pacing leads with a pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.

  • Ventricular Pacing Threshold Rise [ Time Frame: 1 Month ] [ Designated as safety issue: Yes ]
    Evaluate the percentage of ventricular pacing leads with a pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.

  • P-wave Sensing Attenuation [ Time Frame: 1 Month ] [ Designated as safety issue: Yes ]
    Evaluate the percentage of subjects who experience P-wave attenuation between the pre-MRI and one-month post-MRI follow-up.

  • R-wave Sensing Attenuation [ Time Frame: 1 Month ] [ Designated as safety issue: Yes ]
    Evaluate the percentage of subjects who experience R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.


Enrollment: 150
Study Start Date: February 2013
Study Completion Date: May 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761162

  Show 25 Study Locations
Sponsors and Collaborators
Biotronik, Inc.
  More Information

No publications provided

Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT01761162     History of Changes
Other Study ID Numbers: G120226
Study First Received: January 2, 2013
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 19, 2014