Clinical trial NCT02488681: Micra Transcatheter Pacing System Continued Access Study Protocol
Official title: Medtronic Micra Transcatheter Pacing System Continued Access Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2015-07-02
Enrollment: 285
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: Medtronic is sponsoring the Micra Continued Access (CA) study to provide continued access to the Micra System while the marketing application is under review by the Food and Drug Administration (FDA).

Detailed description: The Micra CA study is a prospective, non-randomized, multi-center, study designed to allow controlled access of the Micra system when used as intended. All subjects enrolled in the Micra CA Study will be prospectively followed from implant, at 6-month intervals until study closure (i.e. FDA approval). Patients with previous or existing inactive implanted cardiac stimulation systems will have additional follow ups.

Eligibility criteria: Inclusion Criteria:

* Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Subject meets Class I or ll indication for implantation of single chamber ventricular pacemaker and is intended to be implanted with a Micra System
* Subject able and accessible for follow-up per study requirements
* Subject is at least 18 years of age
* Patient is not enrolled in a concurrent drug and/or device study that may confound registry result.

Exclusion Criteria:

* Subject has had an acute myocardial infraction (AMI) within 30 days of implant
* Subject has implantation of neurostimulator or any other chronically implanted device which uses current in the body
* Subject with mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD)
* Subjects who are morbidly obese and physician believes telemetry communication of ≤5 inches (12.5 cm) could not be obtained with programmer head.
* Subject who femoral venous anatomy is unable to accommodate a 23 French introducer sheath or implant on the right side of the heart (for example due to obstructions or sever tortuosity) in the opinion of the implanter
* Subjects with known intolerance to Nickel-Titanium (Nitinol) Alloy
* Subject for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated
* Subjects with life expectancy less than 12-months
* Subject is enrolled in a concurrent drug and/or device study that may confound CA study results

Primary outcomes:
measure: Complications
timeFrame: 3 months post last follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Jacksonville
country: United States
facility: Baptist Heart Specialists
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Saint Cloud
country: United States
facility: CentraCare Heart and Vascular Center
state: Minnesota
city: Kansas City
country: United States
facility: Mid America Heart Institute
state: Missouri
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Manhasset
country: United States
facility: North Shore LIJ Health System
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: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital Research Foundation
state: Oklahoma
city: Portland
country: United States
facility: Providence Health and Services
state: Oregon
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center UPMC Presbyterian
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Institute for Medical Research
state: Pennsylvania
city: Germantown
country: United States
facility: The Stern Cardiovascular Foundation
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center Heart and Vascular Institute
state: Tennessee
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Houston
country: United States
facility: CHI Saint Luke's Health - Baylor Saint Luke's Medical Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Milwaukee
country: United States
facility: Aurora Cardiovascular Services
state: Wisconsin
Study officials:
References:
citation: Piccini JP, Cunnane R, Steffel J, El-Chami MF, Reynolds D, Roberts PR, Soejima K, Steinwender C, Garweg C, Chinitz L, Ellis CR, Stromberg K, Fagan DH, Mont L. Development and validation of a risk score for predicting pericardial effusion in patients undergoing leadless pacemaker implantation: experience with the Micra transcatheter pacemaker. Europace. 2022 Jul 21;24(7):1119-1126. doi: 10.1093/europace/euab315.
citation: El-Chami MF, Shinn T, Bansal S, Martinez-Sande JL, Clementy N, Augostini R, Ravindran B, Sagi V, Ramanna H, Garweg C, Roberts PR, Soejima K, Stromberg K, Fagan DH, Zuniga N, Piccini JP. Leadless pacemaker implant with concomitant atrioventricular node ablation: Experience with the Micra transcatheter pacemaker. J Cardiovasc Electrophysiol. 2021 Mar;32(3):832-841. doi: 10.1111/jce.14881. Epub 2021 Jan 23.
citation: Garg A, Koneru JN, Fagan DH, Stromberg K, Padala SK, El-Chami MF, Roberts PR, Piccini JP, Cheng A, Ellenbogen KA. Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker. Heart Rhythm. 2020 Dec;17(12):2056-2063. doi: 10.1016/j.hrthm.2020.07.035. Epub 2020 Aug 4.