EMRI SureScan™ Clinical Study

This study has been completed.
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00433654
First received: February 2, 2007
Last updated: October 17, 2011
Last verified: July 2011
  Purpose

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).


Condition Intervention
Bradycardia
Slow Heart Beat
Device: Implantable Pulse Generator (IPG) and Pacing Leads (wires)
Other: Magnetic Resonance Imaging (MRI) scan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: EnRhythm MRI™ SureScan™ Pacing System Clinical Investigation

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Magnetic Resonance Imaging (MRI)-Related Complications [ Time Frame: MRI scan to one-month post-MRI scan ] [ Designated as safety issue: No ]
    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.

  • Atrial Pacing Capture Threshold Success [ Time Frame: 9-12 week visit to 4-month visit ] [ Designated as safety issue: No ]
    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.

  • Ventricular Pacing Capture Threshold Success [ Time Frame: 9-12 week visit to 4-month visit ] [ Designated as safety issue: No ]
    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.

  • Atrial Sensed Amplitude Success [ Time Frame: 9-12 week visit to 4-month visit ] [ Designated as safety issue: No ]
    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).

  • Ventricular Sensed Amplitude Success [ Time Frame: 9-12 week visit to 4-month visit ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Subjects With System-related Complications [ Time Frame: Implant to 4 Months ] [ Designated as safety issue: No ]
    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.

  • System Related Adverse Device Effects Due to Labeling Instructions [ Time Frame: Implant through 18 months post-implant ] [ Designated as safety issue: No ]
    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.

  • Occurrence of Arrhythmias [ Time Frame: During the MRI scan ] [ Designated as safety issue: No ]
    Number of participants with sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan that were considered attributable to the MRI scan

  • Atrial Lead Impedance Change [ Time Frame: 9-12 week visit and 4-month visit ] [ Designated as safety issue: No ]
    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.

  • Ventricular Lead Impedance Change [ Time Frame: 9-12 week visit and 4-month visit ] [ Designated as safety issue: No ]
    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.

  • Atrial Lead Handling Rating [ Time Frame: During implant ] [ Designated as safety issue: No ]
    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.

  • Ventricular Lead Handling Rating [ Time Frame: During implant ] [ Designated as safety issue: No ]
    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.

  • Atrial Pacing Capture Threshold [ Time Frame: 3 or 4 months post-implant ] [ Designated as safety issue: No ]
    Average atrial pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.

  • Ventricular Pacing Capture Threshold [ Time Frame: 3 or 4 months post-implant ] [ Designated as safety issue: No ]
    Average ventricular pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.

  • Atrial Sensed Amplitude [ Time Frame: 3 or 4 months post-implant ] [ Designated as safety issue: No ]
    Average atrial sensed amplitude.

  • Ventricular Sensed Amplitude [ Time Frame: 3 or 4 months post-implant ] [ Designated as safety issue: No ]
    Average ventricular sensed amplitude.


Enrollment: 484
Study Start Date: February 2007
Study Completion Date: August 2010
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433654

  Show 45 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: EMRI SureScan Clinical Study Team Medtronic
  More Information

No publications provided

Responsible Party: EMRI Clinical Research Specialist, Medtronic, Inc.
ClinicalTrials.gov Identifier: NCT00433654     History of Changes
Other Study ID Numbers: 212
Study First Received: February 2, 2007
Results First Received: January 11, 2011
Last Updated: October 17, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Austria: Federal bureau for security in public health
Belgium: Ministry of Social Affairs, Public Health and the Environment
Germany: Bezirksregierung Dusseldorf
Italy: Ministry of Health
Netherlands: Federal Ministry of Social Affairs, public health and Environment Service Medical Aids
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Bradycardia
Slow heart beat
Magnetic resonance imaging (MRI)

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014