Micra Transcatheter Pacing System Continued Access Study Protocol

Medtronic Micra Transcatheter Pacing System Continued Access Study

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).

Study Overview

• Status: Completed
• Conditions: Bradycardia
• Intervention / Treatment: Device: Micra Pacemaker Implant

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.

• Study Type: Interventional
• Enrollment (Actual): 285
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University
  • Florida
    • Jacksonville, Florida, United States
      • Baptist Heart Specialists
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami
  • Georgia
    • Atlanta, Georgia, United States
      • Emory University
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Iowa Heart Center
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • Michigan Heart
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation
    • Saint Cloud, Minnesota, United States, 56303
      • CentraCare Heart and Vascular Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Mid America Heart institute
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Memorial Hospital
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore Lij Health System
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Science Center
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Heart Hospital Research Foundation
  • Oregon
    • Portland, Oregon, United States, 97220
      • Providence Health and Services
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17604
      • Lancaster General Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center UPMC Presbyterian
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Institute for Medical Research
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The Stern Cardiovascular Foundation
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center Heart and Vascular Institute
  • Texas
    • Dallas, Texas, United States, 75204
      • Baylor Research Institute
    • Houston, Texas, United States, 77030
      • CHI Saint Luke's Health - Baylor Saint Luke's Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Cardiovascular Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Micra Pacemaker Implant	Device: Micra Pacemaker Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Micra system and/or procedure-related complication rate	3 months post last follow up

Collaborators and Investigators

• Sponsor: Medtronic

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: June 18, 2015
• First Submitted That Met QC Criteria: June 30, 2015
• First Posted (Estimate): July 2, 2015

Study Record Updates

• Last Update Posted (Actual): April 12, 2018
• Last Update Submitted That Met QC Criteria: March 16, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: Micra CA