Trial Outcomes & Findings for Evaluation of Approved Pacing Lead (Model 5076) for Use in MRI Environment (NCT NCT01755143)
NCT ID: NCT01755143
Last Updated: 2015-07-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
266 participants
Primary outcome timeframe
Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period
Results posted on
2015-07-20
Participant Flow
Participant milestones
| Measure |
MRI Group
Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.
Magnetic Resonance Imaging scan sequences of the head, neck, and chest
Pacemaker System
|
Control Group
Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.
Pacemaker System
|
|---|---|---|
|
Overall Study
STARTED
|
177
|
89
|
|
Overall Study
COMPLETED
|
166
|
86
|
|
Overall Study
NOT COMPLETED
|
11
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Approved Pacing Lead (Model 5076) for Use in MRI Environment
Baseline characteristics by cohort
| Measure |
MRI Group
n=177 Participants
Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.
Magnetic Resonance Imaging scan sequences of the head, neck, and chest
Pacemaker System
|
Control Group
n=89 Participants
Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.
Pacemaker System
|
Total
n=266 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.0 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
67.8 Years
STANDARD_DEVIATION 15.1 • n=7 Participants
|
69.2 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
52 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
26 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: MRI scan to one month laterPopulation: Patients who underwent an MRI
Number of patients free of MRI-related complications
Outcome measures
| Measure |
MRI Group
n=156 Participants
Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.
Magnetic Resonance Imaging scan sequences of the head, neck, and chest
Pacemaker System
|
Control Group
Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.
Pacemaker System
|
|---|---|---|
|
MRI-related Complication Free Rate
|
156 participants
|
—
|
PRIMARY outcome
Timeframe: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting periodPopulation: 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.
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.
Outcome measures
| Measure |
MRI Group
n=142 Participants
Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.
Magnetic Resonance Imaging scan sequences of the head, neck, and chest
Pacemaker System
|
Control Group
n=80 Participants
Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.
Pacemaker System
|
|---|---|---|
|
Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Atrial Voltage Thresholds
|
142 participants
|
80 participants
|
PRIMARY outcome
Timeframe: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting periodSubjects' 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.
Outcome measures
| Measure |
MRI Group
n=153 Participants
Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.
Magnetic Resonance Imaging scan sequences of the head, neck, and chest
Pacemaker System
|
Control Group
n=82 Participants
Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.
Pacemaker System
|
|---|---|---|
|
Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Ventricular Voltage Thresholds
|
152 participants
|
82 participants
|
SECONDARY outcome
Timeframe: Pre-MRI /waiting period (9-12 weeks post-implant) to 1-month post-MRI/waiting periodPopulation: Only subjects with measured sensed amplitude values at both pre-MRI/waiting period and the 4-month visit were used in the analysis.
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.
Outcome measures
| Measure |
MRI Group
n=144 Participants
Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.
Magnetic Resonance Imaging scan sequences of the head, neck, and chest
Pacemaker System
|
Control Group
n=81 Participants
Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.
Pacemaker System
|
|---|---|---|
|
Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Atrial Sensing Amplitude
|
141 participants
|
78 participants
|
SECONDARY outcome
Timeframe: During MRI scans (9-12 weeks post-implant)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 Adverse Events Adjudication Committee
Outcome measures
| Measure |
MRI Group
n=159 Participants
Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.
Magnetic Resonance Imaging scan sequences of the head, neck, and chest
Pacemaker System
|
Control Group
Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.
Pacemaker System
|
|---|---|---|
|
Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting periodSubjects' 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.
Outcome measures
| Measure |
MRI Group
n=139 Participants
Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.
Magnetic Resonance Imaging scan sequences of the head, neck, and chest
Pacemaker System
|
Control Group
n=79 Participants
Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.
Pacemaker System
|
|---|---|---|
|
Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Ventricular Sensing Amplitude
|
134 participants
|
76 participants
|
Adverse Events
MRI Group
Serious events: 28 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MRI Group
n=177 participants at risk
Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.
Magnetic Resonance Imaging scan sequences of the head, neck, and chest
Pacemaker System
|
Control Group
n=89 participants at risk
Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.
Pacemaker System
|
|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.56%
1/177 • Number of events 1 • Implant to six-months post-implant
|
0.00%
0/89 • Implant to six-months post-implant
|
|
Cardiac disorders
Angina Unstable
|
0.56%
1/177 • Number of events 1 • Implant to six-months post-implant
|
0.00%
0/89 • Implant to six-months post-implant
|
|
Cardiac disorders
Atrial Fibrillation
|
3.4%
6/177 • Number of events 6 • Implant to six-months post-implant
|
0.00%
0/89 • Implant to six-months post-implant
|
|
Cardiac disorders
Atrial Flutter
|
0.56%
1/177 • Number of events 1 • Implant to six-months post-implant
|
0.00%
0/89 • Implant to six-months post-implant
|
|
Cardiac disorders
Cardiac Failure
|
0.56%
1/177 • Number of events 1 • Implant to six-months post-implant
|
1.1%
1/89 • Number of events 1 • Implant to six-months post-implant
|
|
Cardiac disorders
Coronary Artery Disease
|
0.56%
1/177 • Number of events 1 • Implant to six-months post-implant
|
0.00%
0/89 • Implant to six-months post-implant
|
|
Gastrointestinal disorders
Femoral Hernia
|
0.56%
1/177 • Number of events 1 • Implant to six-months post-implant
|
0.00%
0/89 • Implant to six-months post-implant
|
|
General disorders
Device Dislocation
|
1.1%
2/177 • Number of events 2 • Implant to six-months post-implant
|
2.2%
2/89 • Number of events 2 • Implant to six-months post-implant
|
|
General disorders
Device Lead Issue
|
0.56%
1/177 • Number of events 1 • Implant to six-months post-implant
|
0.00%
0/89 • Implant to six-months post-implant
|
|
General disorders
Device Pacing Issue
|
0.56%
1/177 • Number of events 1 • Implant to six-months post-implant
|
2.2%
2/89 • Number of events 2 • Implant to six-months post-implant
|
|
General disorders
Implant Site Haematoma
|
0.56%
1/177 • Number of events 1 • Implant to six-months post-implant
|
0.00%
0/89 • Implant to six-months post-implant
|
|
General disorders
Local Swelling
|
0.56%
1/177 • Number of events 1 • Implant to six-months post-implant
|
0.00%
0/89 • Implant to six-months post-implant
|
|
Infections and infestations
Pneumonia
|
0.56%
1/177 • Number of events 1 • Implant to six-months post-implant
|
0.00%
0/89 • Implant to six-months post-implant
|
|
Infections and infestations
Postoperative Wound Infection
|
0.56%
1/177 • Number of events 1 • Implant to six-months post-implant
|
0.00%
0/89 • Implant to six-months post-implant
|
|
Injury, poisoning and procedural complications
Wound Haematoma
|
0.56%
1/177 • Number of events 1 • Implant to six-months post-implant
|
0.00%
0/89 • Implant to six-months post-implant
|
|
Investigations
Blood Sodium Decreased
|
0.56%
1/177 • Number of events 1 • Implant to six-months post-implant
|
0.00%
0/89 • Implant to six-months post-implant
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/177 • Implant to six-months post-implant
|
1.1%
1/89 • Number of events 1 • Implant to six-months post-implant
|
|
Nervous system disorders
Syncope
|
1.1%
2/177 • Number of events 2 • Implant to six-months post-implant
|
0.00%
0/89 • Implant to six-months post-implant
|
|
Psychiatric disorders
Mental Disorder
|
0.56%
1/177 • Number of events 1 • Implant to six-months post-implant
|
0.00%
0/89 • Implant to six-months post-implant
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.56%
1/177 • Number of events 1 • Implant to six-months post-implant
|
0.00%
0/89 • Implant to six-months post-implant
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
2/177 • Number of events 2 • Implant to six-months post-implant
|
0.00%
0/89 • Implant to six-months post-implant
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.7%
3/177 • Number of events 3 • Implant to six-months post-implant
|
0.00%
0/89 • Implant to six-months post-implant
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.56%
1/177 • Number of events 1 • Implant to six-months post-implant
|
0.00%
0/89 • Implant to six-months post-implant
|
|
Surgical and medical procedures
Medical Device Removal
|
0.56%
1/177 • Number of events 1 • Implant to six-months post-implant
|
0.00%
0/89 • Implant to six-months post-implant
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.56%
1/177 • Number of events 1 • Implant to six-months post-implant
|
0.00%
0/89 • Implant to six-months post-implant
|
|
Vascular disorders
Hypertension
|
0.00%
0/177 • Implant to six-months post-implant
|
1.1%
1/89 • Number of events 1 • Implant to six-months post-implant
|
|
Vascular disorders
Thrombosis
|
0.56%
1/177 • Number of events 1 • Implant to six-months post-implant
|
0.00%
0/89 • Implant to six-months post-implant
|
Other adverse events
Adverse event data not reported
Additional Information
5076MRI Clinical Team
Medtronic Cardiac Rhythm and Heart Failure
Phone: 1-800-328-2518
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place