ProMRI Study of the Entovis Pacemaker System

NCT01761162 | Completed Results DMC

• 1 other identifier: G120226
• Study Type: observational
• Target: 229
• Locations: 1 country
• Sites: 25

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.

Conditions

Safety of the ProMRI Pacemaker System Under Specific MRI Conditions

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 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

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 head and lower back.

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
• 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

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 (25)

Arizona Arrhythmia Consultants

Scottsdale, Arizona, 85251, United States

Location

John Muir Medical Center

Concord, California, 94520, United States

Location

Hoag Hospital

Newport Beach, California, 92663, United States

Location

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

Location

Yale - New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Washington Hospital Center

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

Location

Unknown Facility

Valparaiso, Indiana, 46383, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Louisiana Heart Rhythm Specialists

Lafayette, Louisiana, 70503, United States

Location

Unknown Facility

Cumberland, Maryland, 21502, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Unknown Facility

Burlington, Massachusetts, 01805, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Saint Joseph Mercy Medical Center

Ypsilanti, Michigan, 48197, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Unknown Facility

Camden, New Jersey, 08103, United States

Location

New York Hospital Queens

Flushing, New York, 11355, United States

Location

Unknown Facility

New York, New York, 10016, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27157, United States

Location

Toledo Hospital

Toledo, Ohio, 46306, United States

Location

Saint Mary Medical Center

Langhorne, Pennsylvania, 19047, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Unknown Facility

Greenville, South Carolina, 29601, United States

Location

Unknown Facility

Richmond, Virginia, 23230, United States

Location

Related Publications (1)

• 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.

  PMID: 25680307 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: January 2, 2013
• First Posted: January 4, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 9, 2017
• Results First Posted: November 4, 2014

Record last verified: 2016-12

Locations

US (25)