MICRA Transcatheter Pacing Study

MICRA Transcatheter Pacing Study - MICRA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38829

Enrollment

Registered

2013-09-16

Start date

2013-12-04

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bradycardia slow heart rate

Interventions

- Implantation of a leadless single chamber pacemaker (Micra transcatheter Pacing System)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Subjects who have a Class I or II indication for implantation of a single chamber pacemaker according to ACC/AHA/HRS 2008 guidelines and any national guidelines.

Exclusion criteria

Exclusion criteria: Subjects who are entirely pacemaker dependent (escape rhythm

Design outcomes

Primary

Measure	Time frame
See protocol page 22-24, 84-95 Primary Objectives: • Demonstrate that the freedom from acute major complications related to the Micra system and/or procedure at 6 months post-implant is greater than 83% • Demonstrate that the percentage of subjects with an adequate pacing capture threshold at 6-months post-implant exceeds 80%.	—

Secondary

Measure	Time frame
See protocol page 24, 95-100 Secondary Objectives: • Demonstrate the accuracy of Micra ventricular capture management pacing thresholds compared to manual pacing capture thresholds. • Demonstrate the rate response operation of the Micra system.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)