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Accelerometer Sensing for Micra AV Study (AccelAV)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Accelerometer Sensing for Micra AV Study
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for AV Block focused on measuring AV Synchrony, Micra AV, Micra, Transcatheter Pacing, Normal Sinus Node Function, Leadless Pacemaker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Saint Joseph's Medical Center
  • Baptist Medical Center Jacksonville
  • Citrus Cardiology Consultants PA
  • Emory University Hospital
  • Catholic Medical Center
  • Northwell Health
  • NYU Langone Medical Center
  • Duke University Nedical Center
  • Wake Forest Baptist Medical Center
  • University Hospitals Cleveland Medical Center
  • The Ohio State University Wexner Medical Center
  • Mount Carmel Health System
  • Oregon Health & Science University
  • Thomas Jefferson University
  • Centennial Heart Cardiovascular Consultants
  • Baylor Research Institute
  • Multicare Institute for Research and Innovation
  • University of Wisconsin (UW) Hospital and Clinics
  • Queen Mary Hospital
  • Prince of Wales Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single-arm

Arm Description

Subjects implanted with the Medtronic Micra AV device

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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

Full Information

First Posted
January 21, 2020
Last Updated
February 21, 2023
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT04245345
Brief Title
Accelerometer Sensing for Micra AV Study
Acronym
AccelAV
Official Title
Accelerometer Sensing for Micra AV Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 9, 2020 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AV Block, AV Block Complete, 3rd Degree Heart Block, Complete Heart Block
Keywords
AV Synchrony, Micra AV, Micra, Transcatheter Pacing, Normal Sinus Node Function, Leadless Pacemaker

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-arm
Arm Type
Other
Arm Description
Subjects implanted with the Medtronic Micra AV device
Intervention Type
Device
Intervention Name(s)
Accelerometer Sensing for Micra AV Study
Intervention Description
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.
Primary Outcome Measure Information:
Title
Atrioventricular (AV) Synchrony During Rest at 1-month Post-implant in Subjects With Persistent 3rd Degree Atrioventrcular Block (AVB) and Normal Sinus Node Function
Description
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 Outcome Measure Information:
Title
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
Description
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
Title
Percentage of Ambulatory AV Synchrony at 1-month Post-implant in Subjects With Persistent 3rd Degree AVB and Normal Sinus Node Function
Description
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
Title
Left Ventricular Outflow Tract Velocity Time Integral
Description
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
Time Frame
Within 48 hours of procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry Chinitz, MD
Organizational Affiliation
NYU Langone
Official's Role
Study Chair
Facility Information:
Facility Name
Saint Joseph's Medical Center
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Facility Name
Baptist Medical Center Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Citrus Cardiology Consultants PA
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Catholic Medical Center
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03102
Country
United States
Facility Name
Northwell Health
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Duke University Nedical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Mount Carmel Health System
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Centennial Heart Cardiovascular Consultants
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Baylor Research Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Multicare Institute for Research and Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
University of Wisconsin (UW) Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Queen Mary Hospital
City
Hong Kong
State/Province
HK
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Sha Tin
State/Province
HK
Country
Hong Kong

12. IPD Sharing Statement

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Accelerometer Sensing for Micra AV Study

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