Evaluation of Approved Pacing Lead (Model 5076) for Use i... | NCT01755143

NCT01755143

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MRI Group	Experimental	Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.	Other: Magnetic Resonance Imaging scan sequences of the head, neck, and chest Device: Pacemaker System
Control Group	Sham Comparator	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.	Device: Pacemaker System

Name	Type	Description	Arm Group Labels	Other Names
Magnetic Resonance Imaging scan sequences of the head, neck, and chest	Other		MRI Group
Pacemaker System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MRI-related Complication Free Rate	Number of patients free of MRI-related complications	MRI scan to one month later
Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Atrial Voltage Thresholds	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 (9-12 weeks post implant) to one month post-MRI/waiting period
Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Ventricular Voltage Thresholds	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 (9-12 weeks post implant) to one month post-MRI/waiting period

Secondary Outcomes

Measure	Description	Time Frame
Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Atrial Sensing Amplitude	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 (9-12 weeks post-implant) to 1-month post-MRI/waiting period

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who have Class I and II indication for implantation of a dual chamber pacemaker according to the ACC/AHA/HRS guidelines
Subjects who are able to undergo a pectoral implant
Subjects who:
are receiving an IPG for the first time, OR
are receiving a replacement IPG connected to two previously- implanted (atrial and ventricular) Model 5076 leads
Subjects who are able and willing to undergo elective MRI scanning without sedation
Subjects who are geographically stable and available for follow-up at the study site 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 1.0mg dexamethasone acetate may be contraindicated.
Subjects who require a legally authorized representative to obtain consent.
Subjects who have abandoned (inactive) pacemaker and/or defibrillator leads
Subjects who are immediate candidates for an ICD.
Subjects who require an indicated MRI scan, other than those specifically described in the study, before the one-month post MRI/waiting period follow-up.
Subjects with previously implanted active medical devices (exception Model 5076 Lead and Advisa MRI IPG).
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).

Facility	Status	City	State	ZIP	Country	Contacts
Saint George Hospital		Kogarah	New South Wales	2217	Australia
Flinders Medical Centre

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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
FG001	Control Group

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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
BG001	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
BG002	Total	Total of all reporting groups

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

MRI-related Complication Free Rate

Number of patients free of MRI-related complications

Patients who underwent an MRI

Posted

Number

participants

MRI scan to one month later

ID	Title	Description
OG000	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

Units	Counts
Participants	OG000156

Title

Denominators

Categories

Title	Measurements
	OG000156

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-free rate between the MRI scan and one-month post-MRI <90%.	exact test of binomial proportions		<0.0001	A priori threshold for statistical significance was 0.025	Percentage	100			1-Sided	97.5	97.7					No	Superiority or Other

Primary

Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Atrial Voltage Thresholds

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 (9-12 weeks post implant) to one month post-MRI/waiting period

ID	Title	Description
OG000	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
OG001	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

Primary

Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Ventricular Voltage Thresholds

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 (9-12 weeks post implant) to one month post-MRI/waiting period

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Secondary

Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Atrial Sensing Amplitude

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 (9-12 weeks post-implant) to 1-month post-MRI/waiting period

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

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 Adverse Events Adjudication Committee

Posted

Number

participants

During MRI scans (9-12 weeks post-implant)

ID	Title	Description
OG000	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

Units	Counts
Participants	OG000

Secondary

Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Ventricular Sensing Amplitude

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.

Posted

Number

participants

Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Arm/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 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			28	177	0	177
EG001	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			6	89	0	89

Serious Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Angina Pectoris	Cardiac disorders	MedDRA (Unspecified)	EG0001 events1 affected177 at risk EG0010 events0 affected89 at risk
Angina Unstable	Cardiac disorders	MedDRA (Unspecified)	EG0001 events1 affected177 at risk EG0010 events0 affected89 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (Unspecified)	EG0006 events6 affected177 at risk EG0010 events0 affected89 at risk
Atrial Flutter	Cardiac disorders	MedDRA (Unspecified)	EG0001 events1 affected177 at risk EG0010 events0 affected89 at risk
Cardiac Failure	Cardiac disorders	MedDRA (Unspecified)	EG0001 events1 affected177 at risk EG0011 events1 affected89 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA (Unspecified)	EG0001 events1 affected177 at risk EG0010 events0 affected89 at risk
Femoral Hernia	Gastrointestinal disorders	MedDRA (Unspecified)	EG0001 events1 affected177 at risk EG0010 events0 affected89 at risk
Device Dislocation	General disorders	MedDRA (Unspecified)	EG0002 events2 affected177 at risk EG0012 events2 affected89 at risk
Device Lead Issue	General disorders	MedDRA (Unspecified)	EG0001 events1 affected177 at risk EG0010 events0 affected89 at risk
Device Pacing Issue	General disorders	MedDRA (Unspecified)	EG0001 events1 affected177 at risk EG0012 events2 affected89 at risk
Implant Site Haematoma	General disorders	MedDRA (Unspecified)	EG0001 events1 affected177 at risk EG0010 events0 affected89 at risk
Local Swelling	General disorders	MedDRA (Unspecified)	EG0001 events1 affected177 at risk EG0010 events0 affected89 at risk
Pneumonia	Infections and infestations	MedDRA (Unspecified)	EG0001 events1 affected177 at risk EG0010 events0 affected89 at risk
Postoperative Wound Infection	Infections and infestations	MedDRA (Unspecified)	EG0001 events1 affected177 at risk EG0010 events0 affected89 at risk
Wound Haematoma	Injury, poisoning and procedural complications	MedDRA (Unspecified)	EG0001 events1 affected177 at risk EG0010 events0 affected89 at risk
Blood Sodium Decreased	Investigations	MedDRA (Unspecified)	EG0001 events1 affected177 at risk EG0010 events0 affected89 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	EG0000 events0 affected177 at risk EG0011 events1 affected89 at risk
Syncope	Nervous system disorders	MedDRA (Unspecified)	EG0002 events2 affected177 at risk EG0010 events0 affected89 at risk
Mental Disorder	Psychiatric disorders	MedDRA (Unspecified)	EG0001 events1 affected177 at risk EG0010 events0 affected89 at risk
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	EG0001 events1 affected177 at risk EG0010 events0 affected89 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	EG0002 events2 affected177 at risk EG0010 events0 affected89 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	EG0003 events3 affected177 at risk EG0010 events0 affected89 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	EG0001 events1 affected177 at risk EG0010 events0 affected89 at risk
Medical Device Removal	Surgical and medical procedures	MedDRA (Unspecified)	EG0001 events1 affected177 at risk EG0010 events0 affected89 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA (Unspecified)	EG0001 events1 affected177 at risk EG0010 events0 affected89 at risk
Hypertension	Vascular disorders	MedDRA (Unspecified)	EG0000 events0 affected177 at risk EG0011 events1 affected89 at risk
Thrombosis	Vascular disorders	MedDRA (Unspecified)	EG0001 events1 affected177 at risk EG0010 events0 affected89 at risk