NCT04245345

Accelerometer Sensing for Micra AV Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the AccelAV Study is to characterize chronic AV synchrony in subjects implanted with MicraTM AV device. This study will be conducted upon market approval of the MicraTM AV Transcatheter Pacing System.

Detailed description

The Accel AV study is a prospective, single-arm, global, multi-center clinical study to characterize the chronic AV synchrony in subjects implanted with the market released Micra AV system. The study is planned to be conducted in the US and Hong Kong. Overall, the study is expected to be conducted at approximately 20 centers.The expected total study duration is approximately 12-15 months, representing the time necessary to enroll the target sample size and to complete the 3-month follow-up visit.

Conditions

• AV Block
• AV Block Complete
• 3rd Degree Heart Block
• Complete Heart Block

Interventions

Type	Name	Description
DEVICE	Accelerometer Sensing for Micra AV Study	Characterize AV synchrony in subjects implanted with Micra AV device. The study will be conducted upon market approval of the Micra AV Transcatheter Pacing System.

Timeline

• Start date: 2020-06-09
• Primary completion: 2022-01-01
• Completion: 2022-01-10
• First posted: 2020-01-28
• Last updated: 2023-02-23
• Results posted: 2023-02-13

Locations

20 sites across 2 countries: United States, Hong Kong

Regulatory

• FDA-regulated device study