Health Condition 1: null- Subjects who have Class I and II indication for implantation of a dual chamber pacemaker according to the ACC/AHA/HRS guidelines
Conditions
Interventions
Intervention1: Will study the safety and effectiveness of the
Medtronic CapSureFix Novus Model 5076 lead when used with Medtronicâ??s
Advisa DR MRI (Model A3DR01) SureScan IPG in the clinical MRI (Mag
Sponsors
India Medtronic Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects who have Class I and II indication for implantation of a dual chamber pacemaker according to the ACC/AHA/HRS guidelines 2. Subjects who are able to undergo a pectoral implant 3. Subjects who: are receiving an IPG for the first time, or 4. are receiving a replacement IPG connected to two previouslyâ??implanted Model 5076 leads or 5. Subjects who are able and willing to undergo elective MRI scanning without sedation 6. Subjects who are geographically stable and available for followâ??up at the study site for the length of the study
Exclusion criteria
Exclusion criteria: 1. Subjects with a mechanical tricuspid heart valve. 2. Subjects with a history of significant tricuspid valvular disease. 3. Subjects for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated. 4. Subjects who require a legally authorized representative to obtain consent. 5. Subjects who have abandoned (inactive) pacemaker and/or defibrillator leads 6. Subjects who are immediate candidates for an ICD. 7. Subjects who require an indicated MRI scan, other than those specifically described in the study, before the oneâ??month post MRI/waiting period followâ??up. 8. Subjects with previously implanted active medical devices (exception Model 5076 Lead and Advisa MRI IPG). 9. Subjects with a nonâ??MRI compatible device (such as ICDs or neurostimulators) or material implant (e.g., nonâ??MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys). 10. Subjects with medical conditions that preclude the testing required by the protocol or limit study participation. 11. 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. 12. Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the MRIâ??related complicationâ??free rate one month post MRI. 2. To demonstrate the nonâ??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 preâ??MRI/waiting period to one month postâ??MRI/waiting period .Timepoint: 3 months post implant | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To demonstrate the nonâ??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 preâ??MRI/waiting period to one month postâ??MRI/waiting period. 2. To characterize occurrence of sustained ventricular arrhythmias and asystole seen during MRI scans.Timepoint: 12 weeks post implant | — |
Countries
Australia, China, India, New Zealand, South Africa, United States of America
Contacts
Public ContactRajesh Radhakrishnan
India Medtronic Pvt Ltd
Outcome results
None listed