Clinical trial NCT03157297: Micra Atrial Tracking Using a Ventricular Accelerometer Study
Official title: Micra Atrial Tracking Using a Ventricular Accelerometer Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atrioventricular Conduction Block
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2017-05-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to characterize performance of the MARVEL algorithm downloaded into the MicraTM TPS to provide atrial synchronous ventricular pacing in subjects with AV block.

A sub-study will be conducted within the Marvel study, the purpose of this study is to characterize the MARVEL algorithm in patients who were enrolled in the MARVEL study, and to collect and compare the accelerometer signals and AV synchrony at a second point in time.


Eligibility criteria: Inclusion Criteria:

* Subject has been implanted with, or is expected to be implanted with a MicraTM TPS (Model MC1VR01), with remaining device longevity of 6 years or more.
* Subject is ≥ 18 years old and as per required local law.
* Subject has atrioventricular (AV) block.
* 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 is in atrial arrhythmia at the time of enrollment.
* 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 study manager.
* Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to MARVEL study procedures).
* Subject meets any exclusion criteria required by local law (age or other).

Additional criteria for the MARVEL Evolve Sub-study:

Inclusion criteria:

• Subjects in the MARVEL Sub-Study have previously been enrolled in the MARVEL main study

Primary outcomes:
measure: Atrioventricular synchrony
timeFrame: Initial 24 hour period after patient enrollment
measure: MARVEL Evolve Substudy
timeFrame: Initial 24 hour period after patient enrollment
Secondary outcomes:
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: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Linz
country: Austria
facility: Kepler Universitätsklinikum Med Campus III
city: Leuven
country: Belgium
facility: UZ Leuven - Campus Gasthuisberg
city: Praha 5
country: Czechia
facility: Nemocnice Na Homolce
state: Czech Republic
city: Odense C
country: Denmark
facility: Odense Universitetshospital
city: Pessac
country: France
facility: Hôpital Haut-Lévêque - CHU de Bordeaux
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
state: Ravenna
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
city: Barcelona
country: Spain
facility: Hospital Universitari Clínic de Barcelona
Study officials:
References:
citation: Chinitz L, Ritter P, Khelae SK, Iacopino S, Garweg C, Grazia-Bongiorni M, Neuzil P, Johansen JB, Mont L, Gonzalez E, Sagi V, Duray GZ, Clementy N, Sheldon T, Splett V, Stromberg K, Wood N, Steinwender C. Accelerometer-based atrioventricular synchronous pacing with a ventricular leadless pacemaker: Results from the Micra atrioventricular feasibility studies. Heart Rhythm. 2018 Sep;15(9):1363-1371. doi: 10.1016/j.hrthm.2018.05.004. Epub 2018 May 11.