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EMRI SureScan™ Clinical Study

Primary Purpose

Bradycardia, Slow Heart Beat

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Implantable Pulse Generator (IPG) and Pacing Leads (wires)
Magnetic Resonance Imaging (MRI) scan
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bradycardia focused on measuring Bradycardia, Slow heart beat, Magnetic resonance imaging (MRI)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

MRI group

Control group

Arm Description

The MRI group underwent a one-hour MRI scan at the 9-12 weeks post-implant follow-up.

The control group waited for one hour (no MRI) at the 9-12 weeks post-implant follow-up.

Outcomes

Primary Outcome Measures

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.
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.
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.
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).
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).

Secondary Outcome Measures

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.
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.
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
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.
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.
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.
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.
Atrial Pacing Capture Threshold
Average atrial pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.
Ventricular Pacing Capture Threshold
Average ventricular pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.
Atrial Sensed Amplitude
Average atrial sensed amplitude.
Ventricular Sensed Amplitude
Average ventricular sensed amplitude.

Full Information

First Posted
February 2, 2007
Last Updated
October 17, 2011
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT00433654
Brief Title
EMRI SureScan™ Clinical Study
Official Title
EnRhythm MRI™ SureScan™ Pacing System Clinical Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
This study is a prospective, multi-center global study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia, Slow Heart Beat
Keywords
Bradycardia, Slow heart beat, Magnetic resonance imaging (MRI)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
484 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI group
Arm Type
Active Comparator
Arm Description
The MRI group underwent a one-hour MRI scan at the 9-12 weeks post-implant follow-up.
Arm Title
Control group
Arm Type
Other
Arm Description
The control group waited for one hour (no MRI) at the 9-12 weeks post-implant follow-up.
Intervention Type
Device
Intervention Name(s)
Implantable Pulse Generator (IPG) and Pacing Leads (wires)
Intervention Description
Pacer and leads
Intervention Type
Other
Intervention Name(s)
Magnetic Resonance Imaging (MRI) scan
Intervention Description
One hour MRI scan on the head and lower back.
Primary Outcome Measure Information:
Title
Magnetic Resonance Imaging (MRI)-Related Complications
Description
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.
Time Frame
MRI scan to one-month post-MRI scan
Title
Atrial Pacing Capture Threshold Success
Description
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.
Time Frame
9-12 week visit to 4-month visit
Title
Ventricular Pacing Capture Threshold Success
Description
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.
Time Frame
9-12 week visit to 4-month visit
Title
Atrial Sensed Amplitude Success
Description
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).
Time Frame
9-12 week visit to 4-month visit
Title
Ventricular Sensed Amplitude Success
Description
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).
Time Frame
9-12 week visit to 4-month visit
Secondary Outcome Measure Information:
Title
Subjects With System-related Complications
Description
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.
Time Frame
Implant to 4 Months
Title
System Related Adverse Device Effects Due to Labeling Instructions
Description
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.
Time Frame
Implant through 18 months post-implant
Title
Occurrence of Arrhythmias
Description
Number of participants with sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan that were considered attributable to the MRI scan
Time Frame
During the MRI scan
Title
Atrial Lead Impedance Change
Description
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.
Time Frame
9-12 week visit and 4-month visit
Title
Ventricular Lead Impedance Change
Description
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.
Time Frame
9-12 week visit and 4-month visit
Title
Atrial Lead Handling Rating
Description
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.
Time Frame
During implant
Title
Ventricular Lead Handling Rating
Description
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.
Time Frame
During implant
Title
Atrial Pacing Capture Threshold
Description
Average atrial pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.
Time Frame
3 or 4 months post-implant
Title
Ventricular Pacing Capture Threshold
Description
Average ventricular pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.
Time Frame
3 or 4 months post-implant
Title
Atrial Sensed Amplitude
Description
Average atrial sensed amplitude.
Time Frame
3 or 4 months post-implant
Title
Ventricular Sensed Amplitude
Description
Average ventricular sensed amplitude.
Time Frame
3 or 4 months post-implant

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EMRI SureScan Clinical Study Team
Organizational Affiliation
Medtronic
Official's Role
Study Chair
Facility Information:
City
Redwood City
State/Province
California
Country
United States
City
Salinas
State/Province
California
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Peachtree City
State/Province
Georgia
Country
United States
City
Des Moines
State/Province
Iowa
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
Kansas City
State/Province
Missouri
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Mineola
State/Province
New York
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Erie
State/Province
Pennsylvania
Country
United States
City
Knoxville
State/Province
Tennessee
Country
United States
City
Charlottesville
State/Province
Virginia
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Graz
Country
Austria
City
Linz
Country
Austria
City
Liège
Country
Belgium
City
Mons
Country
Belgium
City
Calgary
State/Province
Alberta
Country
Canada
City
Victoria
State/Province
British Columbia
Country
Canada
City
Kingston
State/Province
Ontario
Country
Canada
City
London
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Sainte-Foy
State/Province
Quebec
Country
Canada
City
Prague
Country
Czech Republic
City
Rouen
Country
France
City
Bad Nauheim
Country
Germany
City
Bonn
Country
Germany
City
Dortmund
Country
Germany
City
Dresden
Country
Germany
City
Essen
Country
Germany
City
Gottingen
Country
Germany
City
Hamburg
Country
Germany
City
Marburg
Country
Germany
City
München
Country
Germany
City
Ulm
Country
Germany
City
Asti
Country
Italy
City
Pescia
Country
Italy
City
Pietra Ligure
Country
Italy
City
Viterbo
Country
Italy
City
Amsterdam
Country
Netherlands
City
Nieuwegein
Country
Netherlands
City
Zurich
Country
Switzerland
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19055703
Citation
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.
Results Reference
derived

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EMRI SureScan™ Clinical Study

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