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Completed

NCT Number: NCT00433654

EMRI SureScan™ Clinical Study

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).

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Slow Heart Beat

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Graz, Austria

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implantable Pulse Generator (IPG) and Pacing Leads (wires)

Device

Pacer and leads

Magnetic Resonance Imaging (MRI) Scan

Other

One hour MRI scan on the head and lower back.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Atrial Sensed Amplitude

    Time frame: 3 or 4 months post-implant

    Average atrial sensed amplitude.

  11. Ventricular Sensed Amplitude

    Time frame: 3 or 4 months post-implant

    Average ventricular sensed amplitude.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

EnRhythm MRI™ SureScan™ Pacing System Clinical Investigation

Important dates

Study start
2007
Primary completion
2008
Study completion
2010
First posted
Feb 12, 2007
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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