MDT-1112 Jugular Access

JRCT ID: jRCT2032230496

Registered date:06/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with conditions eligible for bradycardia pacing and suitable for implantation of a leadless
• Date of first enrollment: 11/12/2023
• Target sample size: 35
• Study type: Interventional
• Intervention(s): implant MDT-1112 TPS through access of the jugular vein

Outcome(s)

Primary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Soejima Kyoko