Accelerometer Sensing for Micra AV Study (AccelAV)

Medtronic

Status: Completed

Conditions: Complete Heart Block; AV Block; AV Block Complete; 3rd Degree Heart Block

Treatments: Device: Accelerometer Sensing for Micra AV Study

Study type: Interventional

Funder types: Industry

Identifiers

NCT04245345

AccelAV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 157 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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157 participants in 1 patient group

Single-arm

Other group

Description:

Subjects implanted with the Medtronic Micra AV device

Treatment:

Device: Accelerometer Sensing for Micra AV Study