Clinical trial NCT04245345: Accelerometer Sensing for Micra AV Study
Official title: Accelerometer Sensing for Micra AV Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2020-01-28
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Atrioventricular (AV) Synchrony During Rest at 1-month Post-implant in Subjects With Persistent 3rd Degree Atrioventrcular Block (AVB) and Normal Sinus Node Function
timeFrame: 1-month post-implant
Secondary outcomes:
measure: 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
timeFrame: Between 1-month and 3-months post-implant
measure: Percentage of Ambulatory AV Synchrony at 1-month Post-implant in Subjects With Persistent 3rd Degree AVB and Normal Sinus Node Function
timeFrame: 1-month post-implant
measure: Left Ventricular Outflow Tract Velocity Time Integral
timeFrame: Within 48 hours of procedure
Other outcomes:
Locations:
city: Stockton
country: United States
facility: Saint Joseph's Medical Center
state: California
city: Jacksonville
country: United States
facility: Baptist Medical Center Jacksonville
state: Florida
city: Leesburg
country: United States
facility: Citrus Cardiology Consultants PA
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Nedical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel Health System
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Nashville
country: United States
facility: Centennial Heart Cardiovascular Consultants
state: Tennessee
city: Plano
country: United States
facility: Baylor Research Institute
state: Texas
city: Tacoma
country: United States
facility: Multicare Institute for Research and Innovation
state: Washington
city: Madison
country: United States
facility: University of Wisconsin (UW) Hospital and Clinics
state: Wisconsin
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
state: HK
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
state: HK
Study officials:
affiliation: NYU Langone
name: Larry Chinitz, MD
role: STUDY_CHAIR
References: