Atrioventricular Conduction Block Clinical Trial
Official title:
Micra Atrial TRacking Using A Ventricular AccELerometer 2
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
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03157297 -
Micra Atrial Tracking Using a Ventricular Accelerometer Study
|
Phase 1 |