Micra Transcatheter Pacing System Continued Access Study Protocol

NCT ID: NCT02488681

Last Updated: 2018-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 285 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-07-31

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.

Conditions

Bradycardia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Micra Pacemaker Implant

Micra Pacemaker Implant

Group Type: EXPERIMENTAL

Micra Pacemaker Implant

Intervention Type: DEVICE

Interventions

Micra Pacemaker Implant

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Yale University

New Haven, Connecticut, United States

Baptist Heart Specialists

Jacksonville, Florida, United States

Baptist Hospital of Miami

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

Iowa Heart Center

West Des Moines, Iowa, United States

Michigan Heart

Ypsilanti, Michigan, United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, United States

Mid America Heart Institute

Kansas City, Missouri, United States

Morristown Memorial Hospital

Morristown, New Jersey, United States

The Valley Hospital

Ridgewood, New Jersey, United States

North Shore LIJ Health System

Manhasset, New York, United States

NYU Langone Medical Center

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, United States

Oklahoma Heart Hospital Research Foundation

Oklahoma City, Oklahoma, United States

Providence Health and Services

Portland, Oregon, United States

Lancaster General Hospital

Lancaster, Pennsylvania, United States

University of Pittsburgh Medical Center UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, United States

The Stern Cardiovascular Foundation

Germantown, Tennessee, United States

Vanderbilt University Medical Center Heart and Vascular Institute

Nashville, Tennessee, United States

Baylor Research Institute

Dallas, Texas, United States

CHI Saint Luke's Health - Baylor Saint Luke's Medical Center

Houston, Texas, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Aurora Cardiovascular Services

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35025987 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33428248 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32763431 (View on PubMed)

Other Identifiers

Micra CA

Identifier Type: -

Identifier Source: org_study_id