EMRI SureScan™ Clinical Study

EnRhythm MRI™ SureScan™ Pacing System Clinical Investigation

The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing System (used in support of Revo MRI™ SureScan Pacing System launch).

Study Overview

• Status: Completed
• Conditions: Bradycardia; Slow Heart Beat
• Intervention / Treatment: Device: Implantable Pulse Generator (IPG) and Pacing Leads (wires); Other: Magnetic Resonance Imaging (MRI) scan

Detailed Description

This study is a prospective, multi-center global study.

• Study Type: Interventional
• Enrollment (Actual): 484
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
  • Linz, Austria
• Belgium
  • Liège, Belgium
  • Mons, Belgium
• Canada
  • Alberta
    • Calgary, Alberta, Canada
  • British Columbia
    • Victoria, British Columbia, Canada
  • Ontario
    • Kingston, Ontario, Canada
    • London, Ontario, Canada
  • Quebec
    • Montreal, Quebec, Canada
    • Sainte-Foy, Quebec, Canada
• Czech Republic
  • Prague, Czech Republic
• France
  • Rouen, France
• Germany
  • Bad Nauheim, Germany
  • Bonn, Germany
  • Dortmund, Germany
  • Dresden, Germany
  • Essen, Germany
  • Gottingen, Germany
  • Hamburg, Germany
  • Marburg, Germany
  • München, Germany
  • Ulm, Germany
• Italy
  • Asti, Italy
  • Pescia, Italy
  • Pietra Ligure, Italy
  • Viterbo, Italy
• Netherlands
  • Amsterdam, Netherlands
  • Nieuwegein, Netherlands
• Switzerland
  • Zurich, Switzerland
• United Kingdom
  • London, United Kingdom
• United States
  • California
    • Redwood City, California, United States
    • Salinas, California, United States
  • Florida
    • Orlando, Florida, United States
  • Georgia
    • Peachtree City, Georgia, United States
  • Iowa
    • Des Moines, Iowa, United States
  • Minnesota
    • Minneapolis, Minnesota, United States
  • Missouri
    • Kansas City, Missouri, United States
    • St. Louis, Missouri, United States
  • New York
    • Mineola, New York, United States
  • Ohio
    • Cincinnati, Ohio, United States
    • Cleveland, Ohio, United States
  • Pennsylvania
    • Erie, Pennsylvania, United States
  • Tennessee
    • Knoxville, Tennessee, United States
  • Virginia
    • Charlottesville, Virginia, United States
    • Norfolk, Virginia, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject has, or is at risk of having, a heart beat that is too slow and his/her doctor has determined he/she needs a pacemaker.
• Subject available for follow-up at study center for length of study.
• Subject able and willing to undergo elective MRI scanning without sedation.

Exclusion Criteria:

• Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD).
• Subject needs or will need another MRI-scan, other than those required by the study, during the required study follow-up period.
• Pregnant women, or women of child bearing potential who are not on a reliable form of birth control.
• Subject with exclusion criteria required by local law.
• Subject who intends to participate in another clinical study during this clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MRI group; The MRI group underwent a one-hour MRI scan at the 9-12 weeks post-implant follow-up.	Device: Implantable Pulse Generator (IPG) and Pacing Leads (wires); Pacer and leads; Other: Magnetic Resonance Imaging (MRI) scan; One hour MRI scan on the head and lower back.
Other: Control group; The control group waited for one hour (no MRI) at the 9-12 weeks post-implant follow-up.	Device: Implantable Pulse Generator (IPG) and Pacing Leads (wires); Pacer and leads

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Magnetic Resonance Imaging (MRI)-Related Complications	Subjects with a complication related to the MRI scan. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the MRI scan.	MRI scan to one-month post-MRI scan
Atrial Pacing Capture Threshold Success	Subjects' atrial pacing capture threshold (the energy sent from the pacemaker needed to make the heart's atrium beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more.	9-12 week visit to 4-month visit
Ventricular Pacing Capture Threshold Success	Subjects' ventricular pacing capture threshold (the energy sent from the pacemaker needed to make the heart's ventricle beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more.	9-12 week visit to 4-month visit
Atrial Sensed Amplitude Success	Subjects' atrial sensed amplitude (the minimum energy produced by the heart's atrium that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 1.5 millivolts (mV).	9-12 week visit to 4-month visit
Ventricular Sensed Amplitude Success	Subjects' ventricular sensed amplitude (the minimum energy produced by the heart's ventricle that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 5.0 millivolts (mV).	9-12 week visit to 4-month visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects With System-related Complications	Subjects with a complication related to the implanted system, which consisted of the pacemaker, leads to the right chambers of the heart (atrium and ventricle), pacemaker software, and programmer. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the system.	Implant to 4 Months
System Related Adverse Device Effects Due to Labeling Instructions	Number of participants with adverse device effects (ADEs) that resulted from insufficiencies or inadequacies in the instructions for use or deployment of the device, or from user error. ADE's were investigator-reported.	Implant through 18 months post-implant
Occurrence of Arrhythmias	Number of participants with sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan that were considered attributable to the MRI scan	During the MRI scan
Atrial Lead Impedance Change	Subjects' atrial lead impedance (a measure of electrical resistance) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Both measurements were conducted by the pacemaker. The difference between the two is reported.	9-12 week visit and 4-month visit
Ventricular Lead Impedance Change	Subjects' ventricular lead impedance (a measure of electrical resistance) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Both measurements were conducted by the pacemaker. The difference between the two is reported.	9-12 week visit and 4-month visit
Atrial Lead Handling Rating	Physicians' rated atrial lead handling during the implant on a scale of -3 to +3 where: -3 = well below expectations; -2 = moderately below expectations; -1 = slightly below expectations; 0 = met expectations; +1 = slightly above expectations; +2 = moderately above expectations; and +3 = well above expectations.	During implant
Ventricular Lead Handling Rating	Physicians' rated ventricular lead handling during the implant on a scale of -3 to +3 where: -3 = well below expectations; -2 = moderately below expectations; -1 = slightly below expectations; 0 = met expectations; +1 = slightly above expectations; +2 = moderately above expectations; and +3 = well above expectations.	During implant
Atrial Pacing Capture Threshold	Average atrial pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.	3 or 4 months post-implant
Ventricular Pacing Capture Threshold	Average ventricular pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.	3 or 4 months post-implant
Atrial Sensed Amplitude	Average atrial sensed amplitude.	3 or 4 months post-implant
Ventricular Sensed Amplitude	Average ventricular sensed amplitude.	3 or 4 months post-implant

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Study Chair: EMRI SureScan Clinical Study Team, Medtronic

Publications and helpful links

General Publications

• Sutton R, Kanal E, Wilkoff BL, Bello D, Luechinger R, Jenniskens I, Hull M, Sommer T. Safety of magnetic resonance imaging of patients with a new Medtronic EnRhythm MRI SureScan pacing system: clinical study design. Trials. 2008 Dec 2;9:68. doi: 10.1186/1745-6215-9-68.

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: February 2, 2007
• First Submitted That Met QC Criteria: February 9, 2007
• First Posted (Estimate): February 12, 2007

Study Record Updates

• Last Update Posted (Estimate): October 24, 2011
• Last Update Submitted That Met QC Criteria: October 17, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Magnetic resonance imaging (MRI); Bradycardia; Slow heart beat
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: 212