| Inclusion criteria |
| Class I or II indication for implantation of a single-chamber ventricular pacemaker2–4 |
| Able to undergo the study requirements |
| 18 years of age (or older, if required by local law) |
| Exclusion criteria |
| Entirely pacemaker dependenta (defined as escape rhythm ≤30 b.p.m.) |
| Existing or prior pacemaker, ICD, or CRT device implant |
| Unstable angina pectoris, acute myocardial infarction within 30 days |
| Current implantation of neurostimulator or any other chronically implanted device which uses current |
| Mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device |
| Morbidly obese where telemetry communication of 12.5 cm cannot be obtained with programmer |
| Femoral venous anatomy unable to accommodate a 23 French introducer sheath or implant on the right side of the heart |
| Unable to tolerate urgent sternotomy |
| Known intolerance to nickel–titanium (nitinol) alloy |
| Contraindication for single dose of 1.0 mg dexamethasone acetate |
| Life expectancy <12 months |
| Enrolment in concurrent confounding study |
| Pregnant or breastfeeding women |
| Inclusion criteria |
| Class I or II indication for implantation of a single-chamber ventricular pacemaker2–4 |
| Able to undergo the study requirements |
| 18 years of age (or older, if required by local law) |
| Exclusion criteria |
| Entirely pacemaker dependenta (defined as escape rhythm ≤30 b.p.m.) |
| Existing or prior pacemaker, ICD, or CRT device implant |
| Unstable angina pectoris, acute myocardial infarction within 30 days |
| Current implantation of neurostimulator or any other chronically implanted device which uses current |
| Mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device |
| Morbidly obese where telemetry communication of 12.5 cm cannot be obtained with programmer |
| Femoral venous anatomy unable to accommodate a 23 French introducer sheath or implant on the right side of the heart |
| Unable to tolerate urgent sternotomy |
| Known intolerance to nickel–titanium (nitinol) alloy |
| Contraindication for single dose of 1.0 mg dexamethasone acetate |
| Life expectancy <12 months |
| Enrolment in concurrent confounding study |
| Pregnant or breastfeeding women |
aRestriction removed after device reliability is verified.
| Inclusion criteria |
| Class I or II indication for implantation of a single-chamber ventricular pacemaker2–4 |
| Able to undergo the study requirements |
| 18 years of age (or older, if required by local law) |
| Exclusion criteria |
| Entirely pacemaker dependenta (defined as escape rhythm ≤30 b.p.m.) |
| Existing or prior pacemaker, ICD, or CRT device implant |
| Unstable angina pectoris, acute myocardial infarction within 30 days |
| Current implantation of neurostimulator or any other chronically implanted device which uses current |
| Mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device |
| Morbidly obese where telemetry communication of 12.5 cm cannot be obtained with programmer |
| Femoral venous anatomy unable to accommodate a 23 French introducer sheath or implant on the right side of the heart |
| Unable to tolerate urgent sternotomy |
| Known intolerance to nickel–titanium (nitinol) alloy |
| Contraindication for single dose of 1.0 mg dexamethasone acetate |
| Life expectancy <12 months |
| Enrolment in concurrent confounding study |
| Pregnant or breastfeeding women |
| Inclusion criteria |
| Class I or II indication for implantation of a single-chamber ventricular pacemaker2–4 |
| Able to undergo the study requirements |
| 18 years of age (or older, if required by local law) |
| Exclusion criteria |
| Entirely pacemaker dependenta (defined as escape rhythm ≤30 b.p.m.) |
| Existing or prior pacemaker, ICD, or CRT device implant |
| Unstable angina pectoris, acute myocardial infarction within 30 days |
| Current implantation of neurostimulator or any other chronically implanted device which uses current |
| Mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device |
| Morbidly obese where telemetry communication of 12.5 cm cannot be obtained with programmer |
| Femoral venous anatomy unable to accommodate a 23 French introducer sheath or implant on the right side of the heart |
| Unable to tolerate urgent sternotomy |
| Known intolerance to nickel–titanium (nitinol) alloy |
| Contraindication for single dose of 1.0 mg dexamethasone acetate |
| Life expectancy <12 months |
| Enrolment in concurrent confounding study |
| Pregnant or breastfeeding women |
aRestriction removed after device reliability is verified.
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