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ProMRI Study of the Entovis Pacemaker System

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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.

Tracking Information
First Submitted Date January 2, 2013
First Posted Date January 4, 2013
Results First Submitted Date October 28, 2014
Results First Posted Date November 4, 2014
Last Update Posted Date February 9, 2017
Study Start Date February 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 31, 2014)
  • MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate [ Time Frame: 1 Month Post-MRI ]
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: January 2, 2013)
  • MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate [ Time Frame: 1 Month ]
  • Atrial Pacing Threshold Rise [ Time Frame: 1 Month ]
    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 ]
    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 ]
    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 ]
    Evaluate the percentage of subjects who experience R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ProMRI Study of the Entovis Pacemaker System
Official Title Not Provided
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Safety of the ProMRI Pacemaker System Under Specific MRI Conditions
Intervention
  • Device: Patients with a ProMRI Pacemaker System
    Bradycardia Slow Heart Beat
  • Other: Magnetic Resonance Imaging (MRI) scan
    MRI scan of head and lower back.
Study Groups/Cohorts Pacemaker Therapy
Patients with a ProMRI Pacemaker System
Interventions:
  • Device: Patients with a ProMRI Pacemaker System
  • Other: Magnetic Resonance Imaging (MRI) scan
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 31, 2014)
229
Original Estimated Enrollment
 (submitted: January 2, 2013)
245
Actual Study Completion Date May 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01761162
Other Study ID Numbers G120226
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Biotronik, Inc.
Study Sponsor Biotronik, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Biotronik, Inc.
Verification Date December 2016