AccelAV: Accelerometer Sensing for Micra AV Study

Sponsor

Medtronic Cardiac Rhythm and Heart Failure (Industry)

Overall Status

Completed

CT.gov ID

NCT04245345

Collaborator

(none)

157

Enrollment

Locations

Arm

19.1

Actual Duration (Months)

7.9

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
AV Block AV Block Complete 3rd Degree Heart Block Complete Heart Block	Device: Accelerometer Sensing for Micra AV Study	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

157 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Accelerometer Sensing for Micra AV Study

Actual Study Start Date :

Jun 9, 2020

Actual Primary Completion Date :

Jan 1, 2022

Actual Study Completion Date :

Jan 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Single-arm	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.

Arm

Intervention/Treatment

Other: Single-arm

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.

Outcome Measures

Primary Outcome Measures

AV synchrony percentage during rest [1-month post-implant]
Characterize percentage of cardiac cycles during the 20-minute resting period at the 1-month follow-up visit, where a paced or sensed ventricular beat is within 300 ms following an ECG confirmed P-wave.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint Joseph's Medical Center	Stockton	California	United States	95204
2	Baptist Medical Center Jacksonville	Jacksonville	Florida	United States	32207
3	Citrus Cardiology Consultants PA	Leesburg	Florida	United States	34748
4	Emory University Hospital	Atlanta	Georgia	United States	30322
5	Catholic Medical Center	Manchester	New Hampshire	United States	03102
6	Northwell Health	Manhasset	New York	United States	11030
7	NYU Langone Medical Center	New York	New York	United States	10016
8	Duke University Nedical Center	Durham	North Carolina	United States	27710
9	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina	United States	27157
10	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
11	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210
12	Mount Carmel Health System	Columbus	Ohio	United States	43213
13	Oregon Health & Science University	Portland	Oregon	United States	97239
14	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
15	Centennial Heart Cardiovascular Consultants	Nashville	Tennessee	United States	37203
16	Baylor Research Institute	Plano	Texas	United States	75093
17	Multicare Institute for Research and Innovation	Tacoma	Washington	United States	98405
18	University of Wisconsin (UW) Hospital and Clinics	Madison	Wisconsin	United States	53792
19	Queen Mary Hospital	Hong Kong	HK	Hong Kong
20	Prince of Wales Hospital	Sha Tin	HK	Hong Kong