Accelerometer Sensing for Micra AV Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- AV Block
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 157
- Locations
- 20
- Primary Endpoint
- Atrioventricular (AV) Synchrony During Rest at 1-month Post-implant in Subjects With Persistent 3rd Degree Atrioventrcular Block (AVB) and Normal Sinus Node Function
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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).
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
Time Frame: 1-month post-implant
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.
Secondary Outcomes
- Left Ventricular Outflow Tract Velocity Time Integral(Within 48 hours of procedure)
- Percentage of Ambulatory AV Synchrony at 1-month Post-implant in Subjects With Persistent 3rd Degree AVB and Normal Sinus Node Function(1-month post-implant)
- 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(Between 1-month and 3-months post-implant)