Clinical trial NCT03752151: Micra Atrial TRacking Using A Ventricular AccELerometer 2
Official title: Micra Atrial TRacking Using A Ventricular AccELerometer 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrioventricular Conduction Block
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2018-11-23
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: Subjects enrolled in the MARVEL 2 study. Enrolled subjects will have the MARVEL 2 algorithm downloaded into their implanted market released Micra device. Each subject will be tested during when the MARVEL 2 algorithm is in monitor mode (VVI pacing) and in adaptive mode (VDD pacing).
Primary purpose: TREATMENT

Brief summary: The purpose of the Micra Atrial TRacking Using A Ventricular AccELerometer 2 (MARVEL 2) study is to demonstrate safe and effective operation of the MARVEL 2 features for providing AV synchronous pacing in patients with normal sinus node function and AV block

Detailed description: The MARVEL 2 study is an acute, prospective, global, multi-center, software-download clinical study. The study is planned to be conducted in US, Europe, and Asia. The study is expected to be conducted at approximately 15-20 centers in up to 100 subjects to obtain at least 70 usable Holter datasets to meet the objectives of the study. The expected total study duration (from first subject enrollment to the exit of the last subject) is approximately 6-months; this represents the time necessary to enroll the target sample size of at least 70 subjects with usable Holter datasets. Software will be downloaded into patients implanted with a Micra device to allow the new algorithm performance to be measured in patients where a Micra device has already been chosen as most appropriate for the patient.

Most enrolled subjects will complete the study procedures during a single study visit. However, subjects enrolling in the study at the time of their Micra implant (anticipated to be approximately 10 subjects) will have the investigational algorithm downloaded following Micra implant, prior to hospital discharge, and approximately 1-month post-implant. This subset of subjects with de novo Micra implants will allow the MARVEL 2 features to be tested at multiple points in the device life cycle.

Since the download algorithm running in a Micra device significantly increases current drain, a 2-4 hour acute study is used to limit the reduction in device longevity.

Eligibility criteria: Inclusion Criteria:

* Subject has been implanted with a Micra TPS (Model MC1VR01) with remaining device longevity of 6 years or more or is expected to be implanted with a Micra TPS.
* 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. \*This includes subjects with normal sinus function and persistent 3rd degree AV block and subjects with other forms of AV block.

Exclusion Criteria:

* Subject is 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 is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to MARVEL 2 study procedures).
* Subject meets any exclusion criteria required by local law (age or other).

Primary outcomes:
measure: Atrial Ventricular Pacing Synchrony Success During Rest
timeFrame: 40 Minutes
measure: Number of Participants Free From Inappropriate Pacemaker Function Events
timeFrame: Through study completion an average of one day
Secondary outcomes:
measure: Left Ventricular Outflow Tract Velocity Time Integral
timeFrame: 12 cardiac cycles
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Baptist Medical Center Jacksonville
state: Florida
city: Miami
country: United States
facility: Baptist Hospital
state: Florida
city: Manhasset
country: United States
facility: North Shore University Hospital- Northwell
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 Medical Center
state: North Carolina
city: Linz
country: Austria
facility: Kepler Universitätsklinikum Med Campus III
city: Leuven
country: Belgium
facility: UZ Leuven - Campus Gasthuisberg
city: Odense C
country: Denmark
facility: Odense Universitetshospital
city: Pessac
country: France
facility: Hôpital Haut-Lévêque - CHU de Bordeaux
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
city: Barcelona
country: Spain
facility: Hospital Universitari Clínic de Barcelona
Study officials:
References:
citation: Garweg C, Khelae SK, Chan JYS, Chinitz L, Ritter P, Johansen JB, Sagi V, Epstein LM, Piccini JP, Pascual M, Mont L, Willems R, Splett V, Stromberg K, Sheldon T, Kristiansen N, Steinwender C. Behavior of AV synchrony pacing mode in a leadless pacemaker during variable AV conduction and arrhythmias. J Cardiovasc Electrophysiol. 2021 Jul;32(7):1947-1957. doi: 10.1111/jce.15061. Epub 2021 May 20.
citation: Garweg C, Khelae SK, Steinwender C, Chan JYS, Ritter P, Johansen JB, Sagi V, Epstein LM, Piccini JP, Pascual M, Mont L, Willems R, Sheldon T, Splett V, Stromberg K, Wood N, Chinitz L. Predictors of atrial mechanical sensing and atrioventricular synchrony with a leadless ventricular pacemaker: Results from the MARVEL 2 Study. Heart Rhythm. 2020 Dec;17(12):2037-2045. doi: 10.1016/j.hrthm.2020.07.024. Epub 2020 Jul 24.
citation: Steinwender C, Khelae SK, Garweg C, Chan JYS, Ritter P, Johansen JB, Sagi V, Epstein LM, Piccini JP, Pascual M, Mont L, Sheldon T, Splett V, Stromberg K, Wood N, Chinitz L. Atrioventricular Synchronous Pacing Using a Leadless Ventricular Pacemaker: Results From the MARVEL 2 Study. JACC Clin Electrophysiol. 2020 Jan;6(1):94-106. doi: 10.1016/j.jacep.2019.10.017. Epub 2019 Nov 11.