Micra Acute Performance AV Japan Registry

JRCT ID: jRCT1032220138

Registered date:16/06/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Cardiac Arrhythmias
• Date of first enrollment: 30/08/2022
• Target sample size: 300
• Study type: Observational

Outcome(s)

• Primary Outcome: The acute major complication rate related to the Micra AV system and/or procedure

Secondary Outcome

The 1-year major complication rate related to the Micra AV system and/or procedure
%AM-VP in patients with greater than 90% ventricular pacing and a primary pacing indication of 3rd degree AV block

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements
Patient is intended to be treated with, an eligible Medtronic product

Exclude criteria

Patient who is, or is expected to be, inaccessible for follow-up
Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the PSR results (i.e., no required intervention that could affect interpretation of all-around product safety and/or effectiveness)

Related Information

• Primary Sponsor: Okai Chie