EMRI SureScan™ Clinical Study
EnRhythm MRI™ SureScan™ Pacing System Clinical Investigation
1 other identifier
interventional
484
11 countries
45
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2007
Longer than P75 for not_applicable
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 2, 2007
CompletedFirst Posted
Study publicly available on registry
February 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedResults Posted
Study results publicly available
August 11, 2011
CompletedSeptember 15, 2025
July 1, 2011
1.8 years
February 2, 2007
January 11, 2011
August 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (11)
Subjects With System-related Complications
Implant to 4 Months
System Related Adverse Device Effects Due to Labeling Instructions
Implant through 18 months post-implant
Occurrence of Arrhythmias
During the MRI scan
Atrial Lead Impedance Change
9-12 week visit and 4-month visit
Ventricular Lead Impedance Change
9-12 week visit and 4-month visit
- +6 more secondary outcomes
Study Arms (2)
MRI group
ACTIVE COMPARATORThe MRI group underwent a one-hour MRI scan at the 9-12 weeks post-implant follow-up.
Control group
OTHERThe control group waited for one hour (no MRI) at the 9-12 weeks post-implant follow-up.
Interventions
Pacer and leads
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 who intends to participate in another clinical study during this clinical study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Unknown Facility
Redwood City, California, United States
Unknown Facility
Salinas, California, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Peachtree City, Georgia, United States
Unknown Facility
Des Moines, Iowa, United States
Unknown Facility
Minneapolis, Minnesota, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Mineola, New York, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Erie, Pennsylvania, United States
Unknown Facility
Knoxville, Tennessee, United States
Unknown Facility
Charlottesville, Virginia, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Graz, Austria
Unknown Facility
Linz, Austria
Unknown Facility
Liège, Belgium
Unknown Facility
Mons, Belgium
Unknown Facility
Calgary, Alberta, Canada
Unknown Facility
Victoria, British Columbia, Canada
Unknown Facility
Kingston, Ontario, Canada
Unknown Facility
London, Ontario, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Sainte-Foy, Quebec, Canada
Unknown Facility
Prague, Czechia
Unknown Facility
Rouen, France
Unknown Facility
Bad Nauheim, Germany
Unknown Facility
Bonn, Germany
Unknown Facility
Dortmund, Germany
Unknown Facility
Dresden, Germany
Unknown Facility
Essen, Germany
Unknown Facility
Göttingen, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Marburg, Germany
Unknown Facility
München, Germany
Unknown Facility
Ulm, Germany
Unknown Facility
Asti, Italy
Unknown Facility
Pescia, Italy
Unknown Facility
Pietra Ligure, Italy
Unknown Facility
Viterbo, Italy
Unknown Facility
Amsterdam, Netherlands
Unknown Facility
Nieuwegein, Netherlands
Unknown Facility
Zurich, Switzerland
Unknown Facility
London, United Kingdom
Related Publications (1)
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.
PMID: 19055703DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Comparisons with a historical control (5076 Lead) were performed for secondary objectives #11-#16, however the results database is currently only designed to allow for reporting of participants specifically enrolled as part of this protocol.
Results Point of Contact
- Title
- EnRhythm MRI Clinical Research Specialist
- Organization
- Medtronic, Inc
Study Officials
- STUDY CHAIR
EMRI SureScan Clinical Study Team
Medtronic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2007
First Posted
February 12, 2007
Study Start
February 1, 2007
Primary Completion
November 1, 2008
Study Completion
August 1, 2010
Last Updated
September 15, 2025
Results First Posted
August 11, 2011
Record last verified: 2011-07