Advisa MRI Clinical Study | NCT01110915

Label	Type	Description	Intervention Names
MRI group	Experimental	Subjects randomized to the MRI group will undergo a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.	Device: Medtronic Advisa MRI Implantable Pulse Generator (IPG) Device: Medtronic CapSureFix MRI™ active fixation MRI lead
Control group	Active Comparator	Subjects randomized to the Control group will wait for one hour without having any MRI scan at 9-12 weeks post-implant.	Device: Medtronic Advisa MRI Implantable Pulse Generator (IPG) Device: Medtronic CapSureFix MRI™ active fixation MRI lead

Name	Type	Description	Arm Group Labels	Other Names
Medtronic Advisa MRI Implantable Pulse Generator (IPG)	Device	Advisa MRI IPG is a dual chamber, multi-programmable IPG indicated to restore heart rates, improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders. The IPG is indicated for use in patients who may benefit from rate-responsive pacing to support cardiac output during varying levels of activity and has been modified for use during an MRI exam.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Magnetic Resonance Imaging (MRI)-Related Complications	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.	MRI scan to one-month post-MRI scan
Atrial Pacing Capture Threshold Success	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.	Pre-MRI/waiting period to one month post-MRI/waiting period
Ventricular Pacing Capture Threshold Success	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.	Pre-MRI /waiting period to 1-month post-MRI/waiting period

Secondary Outcomes

Measure	Description	Time Frame
Atrial Sensed Amplitude Success	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.	Pre-MRI /waiting period to 1-month post-MRI/waiting period

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who have a Class I or II indication for implantation of a dual chamber pacemaker according to the American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines
Subjects who are able to undergo a pectoral implant
Subjects who are able and willing to undergo elective magnetic resonance (MR) scanning without sedation
Subjects who are geographically stable and available for follow-up at the study center for the length of the study

Exclusion Criteria:

Subjects with a mechanical tricuspid heart valve
Subjects with a history of significant tricuspid valvular disease
Subjects for whom a single dose of 1.0 milligram (mg) dexamethasone acetate may be contraindicated
Subjects who require a legally authorized representative to obtain consent
Subjects who have a previously implanted pacemaker or implantable cardioverter defibrillator (ICD) (abandoned pacemaker and/or defibrillator leads are not permitted; however subjects with complete system explants are not excluded)
Subjects who are immediate candidates for an ICD
Subjects who require an indicated MR scan, other than those specifically described in the study, before the 4 months follow-up
Subjects with previously implanted active medical devices
Subjects with a non-MRI compatible device (such as ICDs or neurostimulators) or material implant (e.g. non-MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys)
Subjects with medical conditions that preclude the testing required by the protocol or limit study participation
Subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during this clinical study
Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control
Subjects with exclusion criteria required by local law (e.g. age, breastfeeding)

Name	Affiliation	Role
Advisa MRI Trial Leader	Medtronic	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Central Coast Cardiology		Salinas	California	93901-3901	United States
Mid Florida Cardiology

PubMed Identifier	Type	Citation	Retractions
23333721	Result	Gimbel JR, Bello D, Schmitt M, Merkely B, Schwitter J, Hayes DL, Sommer T, Schloss EJ, Chang Y, Willey S, Kanal E; Advisa MRI System Study Investigators. Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla. Heart Rhythm. 2013 May;10(5):685-91. doi: 10.1016/j.hrthm.2013.01.022. Epub 2013 Jan 17.
23434621	Result

ID	Title	Description
FG000	MRI Group	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.
FG001	Control Group

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Magnetic Resonance Imaging (MRI)-Related Complications

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.

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.

Posted

Number

participants

MRI scan to one-month post-MRI scan

ID	Title	Description
OG000	MRI Group	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.

Units	Counts
Participants	OG000148

Title

Denominators

Categories

Title	Measurements
	OG0000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	Null Hypothesis: MRI-related complication rate between the MRI scan and one-month post-MRI >=10%.	exact test of binomial proportions		<0.0001	A priori threshold for statistical significance was 0.025	Percentage	0			1-Sided	97.5		2.5				No	Superiority or Other

Primary

Atrial Pacing Capture Threshold Success

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.

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.

Posted

Number

participants

Pre-MRI/waiting period to one month post-MRI/waiting period

ID	Title	Description
OG000	MRI Group	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.
OG001	Control Group	Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.

Units	Counts
Participants

Primary

Ventricular Pacing Capture Threshold Success

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.

Posted

Number

participants

Pre-MRI /waiting period to 1-month post-MRI/waiting period

ID	Title	Description
OG000	MRI Group	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.
OG001	Control Group	Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.

Units	Counts
Participants

Secondary

Atrial Sensed Amplitude Success

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.

Only subjects with measured sensed amplitude values at both pre-MRI/waiting period and the 4-month visit were used in the analysis.

Posted

Number

participants

Pre-MRI /waiting period to 1-month post-MRI/waiting period

ID	Title	Description
OG000	MRI Group	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.
OG001	Control Group	Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.

Units	Counts
Participants	OG000

Secondary

Ventricular Sensed Amplitude Success

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.

Only subjects with measured sensed amplitude values at both pre-MRI/waiting period and the 4-month visit were used in the analysis.

Posted

Number

participants

Pre-MRI /waiting period to 1-month post-MRI/waiting period

ID	Title	Description
OG000	MRI Group	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.
OG001	Control Group	Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.

Units	Counts
Participants	OG000

Secondary

Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.

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.

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.

Posted

Number

participants

During MRI scans

ID	Title	Description
OG000	MRI Group	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.

Units	Counts
Participants	OG000

Secondary

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 the AEAC. The AEAC determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the system.

Posted

Number

participants

Implant to four months post implant

ID	Title	Description
OG000	Implanted Subjects	Any subject who underwent a successful implant of the Advisa MRI system.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Statistical Information
Anaemia	Blood and lymphatic system disorders	EG0002 events1 affected177 at risk EG0011 events1 affected86 at risk
Acute coronary syndrome	Cardiac disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Acute myocardial infarction	Cardiac disorders	EG0002 events2 affected177 at risk EG0010 events0 affected86 at risk
Atrial fibrillation	Cardiac disorders	EG0004 events4 affected177 at risk EG0011 events1 affected86 at risk
Cardiac failure	Cardiac disorders	EG0005 events5 affected177 at risk EG0011 events1 affected86 at risk
Cardiac failure congestive	Cardiac disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Cardiac perforation	Cardiac disorders	EG0002 events2 affected177 at risk EG0012 events2 affected86 at risk
Dressler's syndrome	Cardiac disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Myocardial infarction	Cardiac disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Palpitations	Cardiac disorders	EG0002 events2 affected177 at risk EG0010 events0 affected86 at risk
Pericardial effusion	Cardiac disorders	EG0003 events3 affected177 at risk EG0012 events2 affected86 at risk
Supraventricular tachycardia	Cardiac disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Abdominal pain	Gastrointestinal disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Inguinal hernia	Gastrointestinal disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Lip oedema	Gastrointestinal disorders	EG0000 events0 affected177 at risk EG0011 events1 affected86 at risk
Device dislocation	General disorders	EG0008 events7 affected177 at risk EG0017 events5 affected86 at risk
Device pacing issue	General disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Discomfort	General disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Medical device site reaction	General disorders	EG0000 events0 affected177 at risk EG0011 events1 affected86 at risk
Non-cardiac chest pain	General disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Pyrexia	General disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Sudden cardiac death	General disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Undersensing	General disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Bronchitis	Infections and infestations	EG0000 events0 affected177 at risk EG0011 events1 affected86 at risk
Cellulitis	Infections and infestations	EG0002 events1 affected177 at risk EG0011 events1 affected86 at risk
Febrile infection	Infections and infestations	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Gangrene	Infections and infestations	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Gastroenteritis	Infections and infestations	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Implant site infection	Infections and infestations	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Pneumonia	Infections and infestations	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Sepsis	Infections and infestations	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Subdural haematoma	Injury, poisoning and procedural complications	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Hyponatraemia	Metabolism and nutrition disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected177 at risk EG0011 events1 affected86 at risk
Cerebral artery embolism	Nervous system disorders	EG0000 events0 affected177 at risk EG0011 events1 affected86 at risk
Cerebrovascular accident	Nervous system disorders	EG0000 events0 affected177 at risk EG0012 events2 affected86 at risk
Presyncope	Nervous system disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Syncope	Nervous system disorders	EG0002 events2 affected177 at risk EG0011 events1 affected86 at risk
Transient ischaemic attack	Nervous system disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Confusional state	Psychiatric disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Renal failure acute	Renal and urinary disorders	EG0001 events1 affected177 at risk EG0011 events1 affected86 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected177 at risk EG0011 events1 affected86 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected177 at risk EG0011 events1 affected86 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected177 at risk EG0012 events1 affected86 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Angioedema	Skin and subcutaneous tissue disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Deep vein thrombosis	Vascular disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Hypertension	Vascular disorders	EG0001 events1 affected177 at risk EG0010 events0 affected86 at risk
Orthostatic hypotension	Vascular disorders	EG0000 events0 affected177 at risk EG0011 events1 affected86 at risk

ID	Title	Description
BG000	MRI Group	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.
BG001	Control Group	Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MRI Group	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.			45	177	10	177
EG001	Control Group	Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.			21	86	7	86

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Atrial fibrillation	Cardiac disorders				EG0009 events9 affected177 at risk EG0012 events2 affected86 at risk
Device pacing issue	General disorders				EG0001 events1 affected177 at risk EG0015 events5 affected86 at risk