ProMRI Study of the Entovis Pacemaker System (Phase B)

NCT02009696 | Completed Results DMC

• 1 other identifier: G120226 (Phase B)
• Study Type: observational
• Target: 221
• Locations: 1 country
• Sites: 32

Brief Summary

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.

Conditions

Magnetic Resonance Imaging (MRI); Cardiac Pacing

Outcome Measures

Primary Outcomes (5)

• 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 with a pacing threshold increaess between the Pre-MRI and one-month post-MRI follow-up.

  Between Pre-MRI and 1 Month Post-MRI

• Percentage of Participants Free of Ventricular Pacing Threshold Rise

  Evaluate the percentage of ventricular pacing leads with a pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.

  Between Pre-MRI and 1 Month Post-MRI

• Percentage of Participants Free of P-wave Sensing Attenuation

  Evaluate the percentage of subjects who experience P-wave attenuation between the pre-MRI and one-month post-MRI follow-up.

  Between Pre-MRI and 1 Month Post-MRI

• Percentage of Participants Free of R-wave Sensing Attenuation

  Evaluate the percentage of subjects who experience R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.

  Between Pre-MRI and 1 Month Post-MRI

Study Arms (1)

Pacemaker Therapy

Patients with a ProMRI Pacemaker System

Device: Patients with a ProMRI Pacemaker System; Other: Magnetic Resonance Imaging (MRI) scan

Interventions

Patients with a ProMRI Pacemaker System DEVICE

Bradycardia Slow Heart Beat

Pacemaker Therapy

Magnetic Resonance Imaging (MRI) scan OTHER

MRI scan of heart/chest or thoracic spine.

Pacemaker Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik, Inc.: lead

Study Sites (32)

Unknown Facility

Phoenix, Arizona, 85018, United States

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Scottsdale, Arizona, 85251, United States

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Concord, California, 94520, United States

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Newport Beach, California, 92663, United States

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Rancho Mirage, California, 92270, United States

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New Haven, Connecticut, 06510, United States

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Newark, Delaware, 19702-5438, United States

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Washington D.C., District of Columbia, 20010, United States

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Valparaiso, Indiana, 46383, United States

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Iowa City, Iowa, 52242, United States

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Lafayette, Louisiana, 70503, United States

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Cumberland, Maryland, 21502, United States

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Boston, Massachusetts, 02114, United States

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Burlington, Massachusetts, 01805, United States

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Worcester, Massachusetts, 01655, United States

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Ann Arbor, Michigan, 48109, United States

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Ypsilanti, Michigan, 48197, United States

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Kansas City, Missouri, 64132, United States

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St Louis, Missouri, 63110, United States

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Flushing, New York, 11355, United States

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New York, New York, 10016, United States

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The Bronx, New York, 10463, United States

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Winston-Salem, North Carolina, 27157, United States

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Toledo, Ohio, 43615, United States

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Salem, Oregon, 97301, United States

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Newtown, Pennsylvania, 18940, United States

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Greenville, South Carolina, 29605, United States

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Greenville, South Carolina, 29607, United States

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Amarillo, Texas, 79106, United States

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Mechanicsville, Virginia, 23116, United States

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Virginia Beach, Virginia, 23454, United States

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Unknown Facility

Spokane, Washington, 99204, United States

Location

Related Publications (1)

• 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.

  PMID: 26409098 RESULT

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Clinical Studies Engineer
• Organization: Biotronik, Inc.

justin.michalski@biotronik.com

503-927-7230

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 12, 2013
• Study Start: December 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: January 1, 2015
• Last Updated: November 25, 2015
• Results First Posted: July 10, 2015

Record last verified: 2015-10

Locations

US (32)