ProMRI Study of the Entovis Pacemaker System

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

Study Overview

• Status: Completed
• Conditions: Safety of the ProMRI Pacemaker System Under Specific MRI Conditions
• Intervention / Treatment: Device: Patients with a ProMRI Pacemaker System; Other: Magnetic Resonance Imaging (MRI) scan

• Study Type: Observational
• Enrollment (Actual): 229

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Arizona Arrhythmia Consultants
  • California
    • Concord, California, United States, 94520
      • John Muir Medical Center
    • Newport Beach, California, United States, 92663
      • Hoag Hospital
    • Rancho Mirage, California, United States, 92270
      • Eisenhower Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale - New Haven Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Indiana
    • Valparaiso, Indiana, United States, 46383
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Louisiana
    • Lafayette, Louisiana, United States, 70503
      • Louisiana Heart Rhythm Specialists
  • Maryland
    • Cumberland, Maryland, United States, 21502
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Burlington, Massachusetts, United States, 01805
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • Saint Joseph Mercy Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • Research Medical Center
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • New Jersey
    • Camden, New Jersey, United States, 08103
  • New York
    • Flushing, New York, United States, 11355
      • New York Hospital Queens
    • New York, New York, United States, 10016
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
  • Ohio
    • Toledo, Ohio, United States, 46306
      • Toledo Hospital
  • Pennsylvania
    • Langhorne, Pennsylvania, United States, 19047
      • Saint Mary Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Greenville, South Carolina, United States, 29601
  • Virginia
    • Richmond, Virginia, United States, 23230

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate		1 Month Post-MRI
Percentage of Participants Free of Atrial Pacing Threshold Rise	Evaluate the percentage of atrial pacing leads free of pacing threshold increase between the pre-MRI and one-month post-MRI follow-up.	Pre-MRI, 1 Month Post-MRI
Percentage of Participants Free of Ventricular Pacing Threshold Rise	Evaluate the percentage of ventricular pacing leads free of pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.	Pre-MRI, 1 Month Post-MRI
Percentage of Participants Free of P-wave Sensing Attenuation	Evaluate the percentage of subjects free of P-wave attenuation between the pre-MRI and one-month post-MRI follow-up.	Pre-MRI, 1 Month Post-MRI
Percentage of Participants Free of R-wave Sensing Attenuation	Evaluate the percentage of subjects free of R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.	Pre-MRI, 1 Month Post-MRI

Collaborators and Investigators

• Sponsor: Biotronik, Inc.

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: January 2, 2013
• First Submitted That Met QC Criteria: January 2, 2013
• First Posted (ESTIMATE): January 4, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2017
• Last Update Submitted That Met QC Criteria: December 20, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: G120226