NCT04245345

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
2 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

June 9, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 13, 2023

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

1.6 years

First QC Date

January 21, 2020

Results QC Date

December 15, 2022

Last Update Submit

February 21, 2023

Conditions

AV BlockAV Block Complete3rd Degree Heart BlockComplete Heart Block

Keywords

AV SynchronyMicra AVMicraTranscatheter PacingNormal Sinus Node FunctionLeadless Pacemaker

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

  • 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

  • Left Ventricular Outflow Tract Velocity Time Integral

    Within 48 hours of procedure

Study Arms (1)

Single-arm

OTHER

Subjects implanted with the Medtronic Micra AV device

Device: Accelerometer Sensing for Micra AV Study

Interventions

Accelerometer Sensing for Micra AV StudyDEVICE

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.

Single-arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Saint Joseph's Medical Center

Stockton, California, 95204, United States

Location

Baptist Medical Center Jacksonville

Jacksonville, Florida, 32207, United States

Location

Citrus Cardiology Consultants PA

Leesburg, Florida, 34748, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Northwell Health

Manhasset, New York, 11030, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Duke University Nedical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Mount Carmel Health System

Columbus, Ohio, 43213, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Centennial Heart Cardiovascular Consultants

Nashville, Tennessee, 37203, United States

Location

Baylor Research Institute

Plano, Texas, 75093, United States

Location

Multicare Institute for Research and Innovation

Tacoma, Washington, 98405, United States

Location

University of Wisconsin (UW) Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Queen Mary Hospital

Hong Kong, HK, Hong Kong

Location

Prince of Wales Hospital

Shatin, HK, Hong Kong

Location

Related Publications (1)

  • Chinitz LA, El-Chami MF, Sagi V, Garcia H, Hackett FK, Leal M, Whalen P, Henrikson CA, Greenspon AJ, Sheldon T, Stromberg K, Wood N, Fagan DH, Sun Chan JY. Ambulatory atrioventricular synchronous pacing over time using a leadless ventricular pacemaker: Primary results from the AccelAV study. Heart Rhythm. 2023 Jan;20(1):46-54. doi: 10.1016/j.hrthm.2022.08.033. Epub 2022 Sep 6.

    PMID: 36075532DERIVED

MeSH Terms

Conditions

Atrioventricular Block

Condition Hierarchy (Ancestors)

Heart BlockArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Rachel Vasseur, Sr. Clinical Research Specialist
Organization
Medtronic
rachel.s.vasseur@medtronic.com
6123550360

Study Officials

  • Larry Chinitz, MD

    NYU Langone

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 28, 2020

Study Start

June 9, 2020

Primary Completion

January 1, 2022

Study Completion

January 10, 2022

Last Updated

February 23, 2023

Results First Posted

February 13, 2023

Record last verified: 2023-02

Locations

HK(2)US(18)