Accelerometer Sensing for Micra AV Study

Medtronic Cardiac Rhythm and Heart Failure157 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

157

Conditions

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

Interventions

Accelerometer Sensing for Micra AV StudyDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Subject will be implanted with a MicraTM (Model MC1AVR1) for an approved indication. * Subject has history of AV block. * Subject is ≥ 18 years old and as per required local law. * Subject (and/or witness as applicable per local regulations) provides signed and dated authorization and/or consent per institution and local requirements. * Subject is willing and able to comply with the protocol. Exclusion Criteria: * Subject currently enrolled or planning to participate in a potentially confounding drug or device trial during the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic Clinical Research Specialist. * Subject implanted with a MicraTM (Model MC1AVR1) on a non-permanent basis (e.g. CIED infection). * Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to MicraTM Model MC1AVR1 implant procedures). * Subject meets any exclusion criteria required by local law (age or other).

Locations (20)

Saint Joseph's Medical Center

Stockton, California, United States

Outcomes

Primary Outcomes

Atrioventricular (AV) Synchrony During Rest at 1-month Post-implant in Subjects With Persistent 3rd Degree Atrioventrcular Block (AVB) and Normal Sinus Node Function

Atrioventricular synchrony is defined for each P-wave during the 20-minute resting period. Specifically, for each electrocardiogram (ECG) confirmed P-wave that occurs during the 20-minute resting period at the 1-month visit, the endpoint will be considered met if a ventricular beat (ventricular pace or sensed event) is within 300 ms following an ECG confirmed P-wave. The reported percentage is the average percentage of P-waves considered synchronous across all patients during the 20-minute resting period.

Time frame: 1-month post-implant

Secondary Outcomes

Stability of AV Synchrony During Rest Between 1-month and 3-months Post-implant in Subjects With Persistent 3rd Degree AVB and Normal Sinus Node Function

AV synchrony is defined for each ECG confirmed P-wave that occurs during the 20-minute resting period at both the 1-month visit and 3-months visits. For each P-wave the endpoint will be considered met if a ventricular beat (ventricular pace or sensed event) is within 300 ms following an ECG confirmed P-wave. The reported percentages are the average percentage of P-waves considered synchronous across all patients during the 20-minute resting period at each visit (month 1 or month 3).

Time frame: Between 1-month and 3-months post-implant

Percentage of Ambulatory AV Synchrony at 1-month Post-implant in Subjects With Persistent 3rd Degree AVB and Normal Sinus Node Function

AV synchrony is defined for each P-wave during the the 24-hour Holter monitoring period while the subject went about their activities of daily living. Specifically, for each electrocardiogram (ECG) confirmed P-wave that occurs during the 24-hour Holter period at the 1-month visit, the endpoint will be considered met if a ventricular beat (ventricular pace or sensed event) is within 300 ms following an ECG confirmed P-wave. The reported percentage is the average percentage of P-waves considered synchronous across all patients during the 24-hour Holter monitoring period.

Time frame: 1-month post-implant

Data from ClinicalTrials.gov

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