Accelerometer Sensing for Micra AV Study

Not Applicable

Completed

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

Interventions: Device: Accelerometer Sensing for Micra AV Study

Registration Number: NCT04245345

Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 157

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-arm	Accelerometer Sensing for Micra AV Study	Subjects implanted with the Medtronic Micra AV device

Primary Outcome Measures

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

Name	Time	Method
Left Ventricular Outflow Tract Velocity Time Integral	Within 48 hours of procedure	Characterize the change in stroke volume, as measured by left ventricular outflow tract (LVOT) velocity time Integral (VTI), during Micra AV mediated VDD (atrioventricular synchronous ventricular pacing) pacing and VVI (asynchronous ventricular pacing) pacing in subjects with persistent 3rd degree AV block and normal sinus node function
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	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.
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	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).

Trial Locations

Locations (20): Catholic Medical Center
🇺🇸
Manchester, New Hampshire, United States
Baptist Medical Center Jacksonville
🇺🇸
Jacksonville, Florida, United States
Citrus Cardiology Consultants PA
🇺🇸
Leesburg, Florida, United States
Centennial Heart Cardiovascular Consultants
🇺🇸
Nashville, Tennessee, United States
University of Wisconsin (UW) Hospital and Clinics
🇺🇸
Madison, Wisconsin, United States
Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
Baylor Research Institute
🇺🇸
Plano, Texas, United States
Multicare Institute for Research and Innovation
🇺🇸
Tacoma, Washington, United States
Saint Joseph's Medical Center
🇺🇸
Stockton, California, United States
Northwell Health
🇺🇸
Manhasset, New York, United States
NYU Langone Medical Center
🇺🇸
New York, New York, United States
Duke University Nedical Center
🇺🇸
Durham, North Carolina, United States
University Hospitals Cleveland Medical Center
🇺🇸
Cleveland, Ohio, United States
Mount Carmel Health System
🇺🇸
Columbus, Ohio, United States
The Ohio State University Wexner Medical Center
🇺🇸
Columbus, Ohio, United States
Oregon Health & Science University
🇺🇸
Portland, Oregon, United States
Wake Forest Baptist Medical Center
🇺🇸
Winston-Salem, North Carolina, United States
Thomas Jefferson University
🇺🇸
Philadelphia, Pennsylvania, United States
Queen Mary Hospital
🇭🇰
Hong Kong, HK, Hong Kong
Prince of Wales Hospital
🇭🇰
Sha Tin, HK, Hong Kong