Patients with conditions eligible for bradycardia pacing and suitable for implantation of a leadless
Conditions
Interventions
implant MDT-1112 TPS through access of the jugular vein
Sponsors
Soejima Kyoko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject has indication for bradycardia pacing and is eligible for leadless MDT-1112 Transcatheter Pacing System via jugular access, in the opinion of the implanting physician - Subject is >= 18 years old - Subject (or legally authorized representative) provides signed and dated consent per institution and local requirements - Subject is able and willing to comply with protocol
Exclusion criteria
Exclusion criteria: - Subject has an existing pacemaker, ICD or CRT device implant - Subjects whose jugular venous anatomy is unable to accommodate a 23 French introducer sheath, in the opinion of the implanter - Subjects who are currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic Study Manager - Pregnant women or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence. Note: If required by local law, women of childbearing potential must undergo a pregnancy test within seven days prior to MDT-1112 Jugular Access study procedures - Subjects with evidence of an active, systemic infection - Subject has a mechanical tricuspid valve - Subjects for whom telemetry communication cannot be conducted with the implanted unit within 12.5 cm (4.9 in) - Subjects with hypersensitivity to raw materials or whos hypersensitivity to drugs/pharmacological agents required for the procedure (e.g. anticoagulants, antiplatelet drugs, or contrast agents) cannot be properly managed - Subjects in whom a single dose of 1.0 mg of dexamethasone acetate is contraindicated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Objective: Characterize the rate of implant success of the MDT-1112 TPS through the jugular vein Primary Safety Objective: Estimate the acute major complication rate related to the MDT-1112 TPS jugular implant procedure | — |
Contacts
Public ContactChie Okai
Medtronic Japan
Outcome results
None listed