EMRI SureScan™ Clinical Study

August 25, 2025 updated by: Medtronic Cardiac Rhythm and Heart Failure

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
484

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
  • Czechia
      • Prague, Czechia
  • France
      • Rouen, France
  • Germany
      • Bad Nauheim, Germany
      • Bonn, Germany
      • Dortmund, Germany
      • Dresden, Germany
      • Essen, Germany
      • Göttingen, 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Magnetic Resonance Imaging (MRI)-Related Complications
Time Frame: MRI scan to one-month post-MRI scan
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
Time Frame: 9-12 week visit to 4-month visit
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
Time Frame: 9-12 week visit to 4-month visit
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
Time Frame: 9-12 week visit to 4-month visit
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
Time Frame: 9-12 week visit to 4-month visit
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subjects With System-related Complications
Time Frame: Implant to 4 Months
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
Time Frame: Implant through 18 months post-implant
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
Time Frame: During the MRI scan
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
Time Frame: 9-12 week visit and 4-month visit
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
Time Frame: 9-12 week visit and 4-month visit
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
Time Frame: During implant
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
Time Frame: During implant
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
Time Frame: 3 or 4 months post-implant
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
Time Frame: 3 or 4 months post-implant
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
Time Frame: 3 or 4 months post-implant
Average atrial sensed amplitude.
3 or 4 months post-implant
Ventricular Sensed Amplitude
Time Frame: 3 or 4 months post-implant
Average ventricular sensed amplitude.
3 or 4 months post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Cardiac Rhythm and Heart Failure

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: EMRI SureScan Clinical Study Team, Medtronic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2007

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2007

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 212

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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