ProMRI Study of the Entovis Pacemaker System (Phase B)

Overview

The objective of the ProMRI Study (Phase B) is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions without scan exclusion zone.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2014

Interventions

  • Device: Patients with a ProMRI Pacemaker System
    • Bradycardia Slow Heart Beat
  • Other: Magnetic Resonance Imaging (MRI) scan
    • MRI scan of heart/chest or thoracic spine.

Arms, Groups and Cohorts

  • Pacemaker Therapy
    • Patients with a ProMRI Pacemaker System

Clinical Trial Outcome Measures

Primary Measures

  • 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: Between Pre-MRI and 1 Month Post-MRI
    • Evaluate the percentage of atrial pacing leads with a pacing threshold increaess between the Pre-MRI and one-month post-MRI follow-up.
  • Percentage of Participants Free of Ventricular Pacing Threshold Rise
    • Time Frame: Between Pre-MRI and 1 Month Post-MRI
    • Evaluate the percentage of ventricular pacing leads with a 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: Between Pre-MRI and 1 Month Post-MRI
    • Evaluate the percentage of subjects who experience 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: Between Pre-MRI and 1 Month Post-MRI
    • Evaluate the percentage of subjects who experience R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.

Participating in This Clinical Trial

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 – 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Biotronik, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

Citations Reporting on Results

Bailey WM, Mazur A, McCotter C, Woodard PK, Rosenthal L, Johnson W, Mela T; ProMRI Study Investigators. Clinical safety of the ProMRI pacemaker system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance imaging scanning conditions. Heart Rhythm. 2016 Feb;13(2):464-71. doi: 10.1016/j.hrthm.2015.09.021. Epub 2015 Sep 25.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.