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Advisa MRI Clinical Study

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ClinicalTrials.gov Identifier: NCT01110915
Recruitment Status : Completed
First Posted : April 27, 2010
Results First Posted : April 4, 2013
Last Update Posted : April 30, 2013
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Magnetic Resonance Imaging
Cardiac Pacemaker, Artificial
Interventions Device: Medtronic Advisa MRI Implantable Pulse Generator (IPG)
Device: Medtronic CapSureFix MRI™ active fixation MRI lead
Enrollment 269
Recruitment Details Enrollment occurred from June 22, 2010 to October 12, 2011. A total of 269 subjects were enrolled at 35 centers.
Pre-assignment Details A successful implant is defined as having a complete Advisa MRI system implant(Advisa MRI implable pulse generator (IPG) and two Model 5086MRI leads). Six subjects were exited prior to randomization. Of them, 3 subjects did not have an implant attempt and 3 subjects did not have a full Advisa MRI system. All other enrolled subjects were randomized.
Arm/Group Title MRI Group Control Group
Hide Arm/Group Description Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant. Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
Period Title: Overall Study
Started 177 [1] 86 [2]
Completed 167 [3] 84 [3]
Not Completed 10 2
Reason Not Completed
Death             2             1
Lost to Follow-up             1             0
Withdrawal by Subject             7             1
[1]
Subjects being randomized to the MRI group.
[2]
Subjects being randomized to the Control group.
[3]
Subjects completing at least 4 months of follow-up.
Arm/Group Title MRI Group Control Group Total
Hide Arm/Group Description Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant. Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant. Total of all reporting groups
Overall Number of Baseline Participants 177 86 263
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 177 participants 86 participants 263 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
59
  33.3%
24
  27.9%
83
  31.6%
>=65 years
118
  66.7%
62
  72.1%
180
  68.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 177 participants 86 participants 263 participants
68.1  (12.8) 68.7  (10.8) 68.3  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 177 participants 86 participants 263 participants
Female
68
  38.4%
32
  37.2%
100
  38.0%
Male
109
  61.6%
54
  62.8%
163
  62.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 177 participants 86 participants 263 participants
United States 35 17 52
Australia 15 5 20
Canada 5 3 8
Europe 112 56 168
Middle East 10 5 15
1.Primary Outcome
Title Magnetic Resonance Imaging (MRI)-Related Complications
Hide Description For each subject in this objective, the endpoint was the occurrence of an MRI-related complication within 30 days post-MRI. An independent Adverse Event Advisory Committee (AEAC) determined whether each adverse event was a complication and whether it was MRI-related.
Time Frame MRI scan to one-month post-MRI scan
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who had an MRI scan and completed their 4-month visit (or a later follow-up), or had an MRI-related complication within one month post-MRI were included in the analysis.
Arm/Group Title MRI Group
Hide Arm/Group Description:
Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
Overall Number of Participants Analyzed 148
Measure Type: Number
Unit of Measure: participants
0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MRI Group
Comments Null Hypothesis: MRI-related complication rate between the MRI scan and one-month post-MRI >=10%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments A priori threshold for statistical significance was 0.025
Method exact test of binomial proportions
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage
Estimated Value 0
Confidence Interval (1-Sided) 97.5%
2.5
Estimation Comments [Not Specified]
2.Primary Outcome
Title Atrial Pacing Capture Threshold Success
Hide Description Subjects' atrial pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.
Time Frame Pre-MRI/waiting period to one month post-MRI/waiting period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the 9-12 week visit, and all the subjects must have valid pacing capture threshold measurements at pre-MRI/waiting period and the 4-month visit.
Arm/Group Title MRI Group Control Group
Hide Arm/Group Description:
Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
Overall Number of Participants Analyzed 141 75
Measure Type: Number
Unit of Measure: participants
141 75
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MRI Group, Control Group
Comments Null hypothesis: % successes MRI group ≤ % successes Control group -10%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority margin was 10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Farrington-Manning test
Comments A priori threshold for statistical significance was 0.025. Because there were no failures in either group, a p-value could not be calculated.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 0
Estimation Comments [Not Specified]
3.Primary Outcome
Title Ventricular Pacing Capture Threshold Success
Hide Description Subjects' ventricular pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.
Time Frame Pre-MRI /waiting period to 1-month post-MRI/waiting period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the 9-12 week visit, and all the subjects must have valid pacing capture threshold measurements at pre-MRI/waiting period and the 4-month visit.
Arm/Group Title MRI Group Control Group
Hide Arm/Group Description:
Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
Overall Number of Participants Analyzed 149 80
Measure Type: Number
Unit of Measure: participants
146 78
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MRI Group, Control Group
Comments Null hypothesis: % successes MRI group ≤ % successes Control group -10%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority margin was 10%.
Statistical Test of Hypothesis P-Value <0.0001
Comments A priori threshold for statistical significance was 0.025.
Method Farrington-Manning test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-5.0 to 5.9
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Atrial Sensed Amplitude Success
Hide Description Subjects' atrial sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in atrial sensed amplitude between the two visits.
Time Frame Pre-MRI /waiting period to 1-month post-MRI/waiting period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only subjects with measured sensed amplitude values at both pre-MRI/waiting period and the 4-month visit were used in the analysis.
Arm/Group Title MRI Group Control Group
Hide Arm/Group Description:
Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
Overall Number of Participants Analyzed 138 73
Measure Type: Number
Unit of Measure: participants
134 72
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MRI Group, Control Group
Comments Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority margin was 10%.
Statistical Test of Hypothesis P-Value 0.0010
Comments A priori threshold for statistical significance was 0.05.
Method Farrington-Manning test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 1.5
Confidence Interval (1-Sided) 95%
-6.1
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Ventricular Sensed Amplitude Success
Hide Description Subjects' ventricular sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in ventricular sensed amplitude between the two visits.
Time Frame Pre-MRI /waiting period to 1-month post-MRI/waiting period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only subjects with measured sensed amplitude values at both pre-MRI/waiting period and the 4-month visit were used in the analysis.
Arm/Group Title MRI Group Control Group
Hide Arm/Group Description:
Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
Overall Number of Participants Analyzed 140 75
Measure Type: Number
Unit of Measure: participants
138 74
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MRI Group, Control Group
Comments Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority margin was 10%.
Statistical Test of Hypothesis P-Value 0.0001
Comments A priori threshold for statistical significance was 0.05.
Method Farrington-Manning test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 0.1
Confidence Interval (1-Sided) 95%
-4.6
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.
Hide Description The endpoint was the occurrence of sustained ventricular arrhythmias and asystole during MRI scans and attributable to the MR scan. Sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan was considered attributable to the MR scan if so adjudicated by the AEAC.
Time Frame During MRI scans
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects successfully implanted with the Advisa MRI system who underwent MRI scans were included in the analysis. All MRI scans, whether done at the 9-12 week visit in the MRI group, or done at other times in either group were included in this analysis.
Arm/Group Title MRI Group
Hide Arm/Group Description:
Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
Overall Number of Participants Analyzed 156
Measure Type: Number
Unit of Measure: participants
0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MRI Group
Comments Null hypothesis: the proportion of subjects with sustained ventricular arrhythmias and asystole during MRI scans >= 10%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments A priori threshold for statistical significance was 0.05.
Method exact test of binomial proportions
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage
Estimated Value 0
Confidence Interval (1-Sided) 95%
1.9
Estimation Comments [Not Specified]
7.Secondary Outcome
Title System-related Complications
Hide 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 the AEAC. The AEAC determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the system.
Time Frame Implant to four months post implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Implanted Subjects
Hide Arm/Group Description:
Any subject who underwent a successful implant of the Advisa MRI system.
Overall Number of Participants Analyzed 263
Measure Type: Number
Unit of Measure: participants
20
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Implanted Subjects
Comments Null hypothesis: the system-related complication rate between the implant procedure and the 4-months visit >= 20%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments A priori threshold for statistical significance was 0.05.
Method Kaplan-Meier method
Comments [Not Specified]
Method of Estimation Estimation Parameter Complication rate at 4 months
Estimated Value 7.7
Confidence Interval (1-Sided) 95%
10.9
Estimation Comments [Not Specified]
Time Frame Up to 19 months.
Adverse Event Reporting Description Adverse events were collected from all the subjects enrolled in this study, including 263 randomized and 6 non-randomized subjects. Because there were no adverse events in any of the 6 non-randomized subjects, they are not included in the following summary tables for adverse events.
 
Arm/Group Title MRI Group Control Group
Hide Arm/Group Description Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant. Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
All-Cause Mortality
MRI Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MRI Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   45/177 (25.42%)      21/86 (24.42%)    
Blood and lymphatic system disorders     
Anaemia  1/177 (0.56%)  2 1/86 (1.16%)  1
Cardiac disorders     
Acute coronary syndrome  1/177 (0.56%)  1 0/86 (0.00%)  0
Acute myocardial infarction  2/177 (1.13%)  2 0/86 (0.00%)  0
Atrial fibrillation  4/177 (2.26%)  4 1/86 (1.16%)  1
Cardiac failure  5/177 (2.82%)  5 1/86 (1.16%)  1
Cardiac failure congestive  1/177 (0.56%)  1 0/86 (0.00%)  0
Cardiac perforation  2/177 (1.13%)  2 2/86 (2.33%)  2
Dressler's syndrome  1/177 (0.56%)  1 0/86 (0.00%)  0
Myocardial infarction  1/177 (0.56%)  1 0/86 (0.00%)  0
Palpitations  2/177 (1.13%)  2 0/86 (0.00%)  0
Pericardial effusion  3/177 (1.69%)  3 2/86 (2.33%)  2
Supraventricular tachycardia  1/177 (0.56%)  1 0/86 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1/177 (0.56%)  1 0/86 (0.00%)  0
Inguinal hernia  1/177 (0.56%)  1 0/86 (0.00%)  0
Lip oedema  0/177 (0.00%)  0 1/86 (1.16%)  1
General disorders     
Device dislocation  7/177 (3.95%)  8 5/86 (5.81%)  7
Device pacing issue  1/177 (0.56%)  1 0/86 (0.00%)  0
Discomfort  1/177 (0.56%)  1 0/86 (0.00%)  0
Medical device site reaction  0/177 (0.00%)  0 1/86 (1.16%)  1
Non-cardiac chest pain  1/177 (0.56%)  1 0/86 (0.00%)  0
Pyrexia  1/177 (0.56%)  1 0/86 (0.00%)  0
Sudden cardiac death  1/177 (0.56%)  1 0/86 (0.00%)  0
Undersensing  1/177 (0.56%)  1 0/86 (0.00%)  0
Infections and infestations     
Bronchitis  0/177 (0.00%)  0 1/86 (1.16%)  1
Cellulitis  1/177 (0.56%)  2 1/86 (1.16%)  1
Febrile infection  1/177 (0.56%)  1 0/86 (0.00%)  0
Gangrene  1/177 (0.56%)  1 0/86 (0.00%)  0
Gastroenteritis  1/177 (0.56%)  1 0/86 (0.00%)  0
Implant site infection  1/177 (0.56%)  1 0/86 (0.00%)  0
Pneumonia  1/177 (0.56%)  1 0/86 (0.00%)  0
Sepsis  1/177 (0.56%)  1 0/86 (0.00%)  0
Injury, poisoning and procedural complications     
Subdural haematoma  1/177 (0.56%)  1 0/86 (0.00%)  0
Metabolism and nutrition disorders     
Hyponatraemia  1/177 (0.56%)  1 0/86 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal pain  1/177 (0.56%)  1 0/86 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  0/177 (0.00%)  0 1/86 (1.16%)  1
Nervous system disorders     
Cerebral artery embolism  0/177 (0.00%)  0 1/86 (1.16%)  1
Cerebrovascular accident  0/177 (0.00%)  0 2/86 (2.33%)  2
Presyncope  1/177 (0.56%)  1 0/86 (0.00%)  0
Syncope  2/177 (1.13%)  2 1/86 (1.16%)  1
Transient ischaemic attack  1/177 (0.56%)  1 0/86 (0.00%)  0
Psychiatric disorders     
Confusional state  1/177 (0.56%)  1 0/86 (0.00%)  0
Renal and urinary disorders     
Renal failure acute  1/177 (0.56%)  1 1/86 (1.16%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1/177 (0.56%)  1 1/86 (1.16%)  1
Pleural effusion  0/177 (0.00%)  0 1/86 (1.16%)  1
Pneumothorax  1/177 (0.56%)  1 0/86 (0.00%)  0
Pulmonary oedema  0/177 (0.00%)  0 1/86 (1.16%)  2
Sleep apnoea syndrome  1/177 (0.56%)  1 0/86 (0.00%)  0
Skin and subcutaneous tissue disorders     
Angioedema  1/177 (0.56%)  1 0/86 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1/177 (0.56%)  1 0/86 (0.00%)  0
Hypertension  1/177 (0.56%)  1 0/86 (0.00%)  0
Orthostatic hypotension  0/177 (0.00%)  0 1/86 (1.16%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MRI Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/177 (5.65%)      7/86 (8.14%)    
Cardiac disorders     
Atrial fibrillation  9/177 (5.08%)  9 2/86 (2.33%)  2
General disorders     
Device pacing issue  1/177 (0.56%)  1 5/86 (5.81%)  5
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Generally, contracts allow investigators to publish study results per the protocol and publication plan. Investigators and Participating Institutions will provide any publication of Study Data generated by PI and/or Participating Institution to Medtronic for review prior to submission to determine if confidential information ("CI") is included and to check for technical correctness. Medtronic may not censor/interfere with the publication beyond the extent necessary to protect CI.
Results Point of Contact
Name/Title: Advisa MRI Clinical Research Specialist
Organization: Medtronic, Inc
Phone: 800-328-2518 ext 62813
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01110915     History of Changes
Other Study ID Numbers: AdvisaMRI
First Submitted: April 23, 2010
First Posted: April 27, 2010
Results First Submitted: February 20, 2013
Results First Posted: April 4, 2013
Last Update Posted: April 30, 2013