Accelerometer Sensing for Micra AV Study

AV Block Clinical Trial

— AccelAV  

Official title:

Accelerometer Sensing for Micra AV Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04245345
• Other study ID #: AccelAV
• Status: Completed
• Phase: N/A
• Start date: June 9, 2020
• Est. completion date: January 10, 2022

Study information

• Verified date: February 2023
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: January 10, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• 3rd Degree Heart Block
• Atrioventricular Block
• AV Block
• AV Block Complete
• Complete Heart Block
• Heart Block

Intervention

Device:
• Accelerometer Sensing for Micra AV Study
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1-month post-implant
Secondary	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).	Between 1-month and 3-months post-implant
Secondary	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.	1-month post-implant
Secondary	Left Ventricular Outflow Tract Velocity Time Integral	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	Within 48 hours of procedure