Health Condition 1: null- Subject is or intended to be implanted with a complete SureScan pacing system consisting of both a right atrial and ventricular 5086MRI Lead (used for pacing and sensing) and a SureScan device
Conditions
Interventions
Intervention1: SureScan pacemakers and the
CapSureFixMRI TM active fixation lead Model 5086MRI: Advisa MRI (Model A3DR01)
Control Intervention1: This is an observational study no comparator agent used
Sponsors
India Medtronic Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements 2 Subject is or intended to be implanted with a complete SureScan pacing system consisting of both a right atrial and ventricular 5086MRI Lead (used for pacing and sensing) and a SureScan device 3 Subject within 30 days of implant (maximum 50% of Chronic Performance Arm enrollment) or subject enrolled into Multiple MRI Scan Arm at the time of MRI scan indication
Exclusion criteria
Exclusion criteria: Subject who is, or will be inaccessible for follow-up ï?§ Implant and follow-up data, including adverse device effects and system modifications at implant through the time of enrollment are unavailable (Section 3.4.1 & 3.4.2 for details of exclusion criteria). ï?§ Subject with exclusion criteria required by local law (Europe, Central Asia [ECA] only)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Demonstrate that the MRI-related complication rate Primary Objective #2: 2.To demonstrate that the complication free survival probability for Model 5086MRI lead placed in the right ventricle (RV) is greater than 92.5% at 5 years post-implant. 3.To demonstrate that the complication free survival probability for Model 5086MRI lead placed in the right atrium (RA) is greater than 92.5% at 5 years post-implant.Timepoint: Follow ups will be done at every 6 months till 5 years post implant | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Characterize the cumulative change in pacing capture thresholds (PCT) for subjects with multiple (2 or more) MRI scans. 2. Summarize all MRI system and scan conditions collected at time of MRI. 3. Summarize all SureScan pacing system related events including failure modes by key term (including lead failure modes) occurring up to five years post-implant. 4. Characterize atrial and ventricular lead impedance.Timepoint: Follow ups will be done at every 6 months till 5 years post implant | — |
Countries
Australia, Canada, Germany, India, Netherlands, United States of America
Contacts
Public ContactRajesh Radhakrishnan
India Medtronic Pvt Ltd
Outcome results
None listed