EMRI SureScan™ Clinical Study

Not Applicable

Completed

Conditions: Bradycardia
Slow Heart Beat

Interventions: Device: Implantable Pulse Generator (IPG) and Pacing Leads (wires)
Other: Magnetic Resonance Imaging (MRI) scan

Registration Number: NCT00433654

Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 484

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MRI group	Implantable Pulse Generator (IPG) and Pacing Leads (wires)	The MRI group underwent a one-hour MRI scan at the 9-12 weeks post-implant follow-up.
MRI group	Magnetic Resonance Imaging (MRI) scan	The MRI group underwent a one-hour MRI scan at the 9-12 weeks post-implant follow-up.
Control group	Implantable Pulse Generator (IPG) and Pacing Leads (wires)	The control group waited for one hour (no MRI) at the 9-12 weeks post-implant follow-up.

Primary Outcome Measures

Name	Time	Method
Magnetic Resonance Imaging (MRI)-Related Complications	MRI scan to one-month post-MRI scan	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	9-12 week visit to 4-month visit	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	9-12 week visit to 4-month visit	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	9-12 week visit to 4-month visit	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	9-12 week visit to 4-month visit	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

Name	Time	Method
Occurrence of Arrhythmias	During the MRI scan	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	9-12 week visit and 4-month visit	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	9-12 week visit and 4-month visit	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	During implant	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	During implant	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	3 or 4 months post-implant	Average atrial pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.
Ventricular Pacing Capture Threshold	3 or 4 months post-implant	Average ventricular pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.
Atrial Sensed Amplitude	3 or 4 months post-implant	Average atrial sensed amplitude.
Ventricular Sensed Amplitude	3 or 4 months post-implant	Average ventricular sensed amplitude.
Subjects With System-related Complications	Implant to 4 Months	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	Implant through 18 months post-implant	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.