The purpose of this clinical study is to confirm safety and effectiveness of the Medtronic 5076 lead when used with Medtronic*s AdvisaDR MRI pacemker in the clinical MRI environment.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objectives
* To assess the MRI-related complication-free rate one month post MRI.
* To demonstrate the non-inferiority of the MRI group compared to the Control
group with regard to the proportion of subjects who experience an increase less
than or equal to 0.50V in 1) atrial and 2) ventricular voltage thresholds at
0.5ms from the pre-MRI/waiting period to one month post-MRI/waiting period.
Secondary outcome
Secondary Objectives
* To demonstrate the non-inferiority of the MRI group compared to the Control
group with regard to the proportion of subjects who experience a decrease less
than or equal to 50% in 1) atrial and 2) ventricular sensing amplitude from the
pre-MRI/waiting period to one month post-MRI/waiting period.
* To characterize occurrence of sustained ventricular arrhythmias and asystole
seen during MRI scans.
Background summary
MRI has grown into one of the most widely used non-invasive imaging modalities.
Various medical disciplines rely on the diagnostic capabilities of MRI because
of its unique ability to discriminate soft tissues.
As a result, there is a growing need for medical devices, which are MRI safe.
Medtronic already relaesed a number of MRI conditional pacemaker systems. The
5076 lead is a commonly used market-relaesed lead without MRI conditional
labelling.
Study objective
The purpose of this clinical study is to confirm safety and effectiveness of
the Medtronic 5076 lead when used with Medtronic*s Advisa
DR MRI pacemker in the clinical MRI environment.
Study design
The 5076 MRI study is a prospective, randomized (2:1), controlled, non-blinded
multi-site international study. The study design is based on the Advisa MRI
SureScan pacing system clinical study, sponsored by Medtronic.
Subjects will have required follow up visits at baseline, implant, at 2
months, 9-12 weeks, one-week post-MRI/waiting period, and one-month
post-MRI/waiting period. The MRI scans, including scans of the thoracic region,
will be obtained for all subjects randomized to the MRI group will occur at the
9-12 weeks visit. The subjects in de control group have a wainting period.
Intervention
Two out of three subjects will obtain a MRI scan 9-12 weeks after implantation.
Study burden and risks
Two out of three subjects will undergo an MRI scan. For subjects in de control
group there is a waiting period. Therefor all patients will come more often to
the hopital for monitoring.
Earl Bakkenstraat 10
Heerlen 6422 PJ
NL
Earl Bakkenstraat 10
Heerlen 6422 PJ
NL
Listed location countries
Age
Inclusion criteria
Patients has an indication for dual chamber pacemaker
Patients is willing to undergo elective MRI scanning
Exclusion criteria
Patient hac contraindication for dual chamber pacemaker
Patient has contraindication for an elective MRI Scan
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01755143 |
| CCMO | NL42906.100.13 |