NCT03752151

Micra Atrial TRacking Using A Ventricular AccELerometer 2

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the Micra Atrial TRacking Using A Ventricular AccELerometer 2 (MARVEL 2) study is to demonstrate safe and effective operation of the MARVEL 2 features for providing AV synchronous pacing in patients with normal sinus node function and AV block

Detailed description

The MARVEL 2 study is an acute, prospective, global, multi-center, software-download clinical study. The study is planned to be conducted in US, Europe, and Asia. The study is expected to be conducted at approximately 15-20 centers in up to 100 subjects to obtain at least 70 usable Holter datasets to meet the objectives of the study. The expected total study duration (from first subject enrollment to the exit of the last subject) is approximately 6-months; this represents the time necessary to enroll the target sample size of at least 70 subjects with usable Holter datasets. Software will be downloaded into patients implanted with a Micra device to allow the new algorithm performance to be measured in patients where a Micra device has already been chosen as most appropriate for the patient. Most enrolled subjects will complete the study procedures during a single study visit. However, subjects enrolling in the study at the time of their Micra implant (anticipated to be approximately 10 subjects) will have the investigational algorithm downloaded following Micra implant, prior to hospital discharge, and approximately 1-month post-implant. This subset of subjects with de novo Micra implants will allow the MARVEL 2 features to be tested at multiple points in the device life cycle. Since the download algorithm running in a Micra device significantly increases current drain, a 2-4 hour acute study is used to limit the reduction in device longevity.

Conditions

• Atrioventricular Conduction Block

Interventions

Type	Name	Description
DEVICE	MARVEL 2 Algorithm Monitor Mode then Adaptive Mode	Software download into implanted Micra device and programmed to MARVEL 2 Monitor Mode then MARVEL 2 Adaptive Mode

Timeline

• Start date: 2019-01-22
• Primary completion: 2019-08-07
• Completion: 2019-08-07
• First posted: 2018-11-23
• Last updated: 2020-06-04
• Results posted: 2020-06-04

Locations

12 sites across 8 countries: United States, Austria, Belgium, Denmark, France, Hong Kong, Malaysia, Spain

Regulatory

• FDA-regulated device study