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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micra Pacemaker Implant | Experimental | Micra Pacemaker Implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micra Pacemaker Implant | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Micra system and/or procedure-related complication rate | 3 months post last follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Yale University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35025987 | Derived | 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. | |
| 33428248 |
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Of the 285 patients that were consented to participate in the study, 276 patients underwent a Micra implant attempt. Nine patients who were consented into the study did not ultimately have a Micra implant attempt prior to study closure.
A total of 285 subjects were consented at 31 research centers in the United States from June 2015 to April 2016 when FDA approval was obtained.
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| ID | Title | Description |
|---|---|---|
| FG000 | Micra Pacemaker Implant | Patients who underwent a Micra implant attempt |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| New Haven |
| Connecticut |
| 06510 |
| United States |
| Baptist Heart Specialists | Jacksonville | Florida | United States |
| Baptist Hospital of Miami | Miami | Florida | 33176 | United States |
| Emory University | Atlanta | Georgia | United States |
| Iowa Heart Center | West Des Moines | Iowa | 50266 | United States |
| Michigan Heart | Ypsilanti | Michigan | 48197 | United States |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | United States |
| CentraCare Heart and Vascular Center | Saint Cloud | Minnesota | 56303 | United States |
| Mid America Heart Institute | Kansas City | Missouri | 64111 | United States |
| Morristown Memorial Hospital | Morristown | New Jersey | 07960 | United States |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | United States |
| North Shore LIJ Health System | Manhasset | New York | 11030 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Oklahoma Health Science Center | Oklahoma City | Oklahoma | 73104 | United States |
| Oklahoma Heart Hospital Research Foundation | Oklahoma City | Oklahoma | 73120 | United States |
| Providence Health and Services | Portland | Oregon | 97220 | United States |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17604 | United States |
| University of Pittsburgh Medical Center UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | United States |
| Lankenau Institute for Medical Research | Wynnewood | Pennsylvania | 19096 | United States |
| The Stern Cardiovascular Foundation | Germantown | Tennessee | 38138 | United States |
| Vanderbilt University Medical Center Heart and Vascular Institute | Nashville | Tennessee | 37232 | United States |
| Baylor Research Institute | Dallas | Texas | 75204 | United States |
| CHI Saint Luke's Health - Baylor Saint Luke's Medical Center | Houston | Texas | 77030 | United States |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | United States |
| Aurora Cardiovascular Services | Milwaukee | Wisconsin | 53215 | United States |
| Derived |
| 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. |
| 32763431 | Derived | 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. |
| COMPLETED |
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| NOT COMPLETED |
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Patients with a Micra implant attempt
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| ID | Title | Description |
|---|---|---|
| BG000 | Micra Pacemaker Implant | All subjects who attempted Micra implant procedure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complications | Micra system and/or procedure-related complication rate | All subjects who attempted Micra implant procedure | Posted | Number | 95% Confidence Interval | % participants with complication | 3 months post last follow up |
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From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Micra Pacemaker Implant | All subjects who attempted Micra implant procedure | 27 | 276 | 16 | 276 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block complete | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cardiac perforation | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Device capturing issue | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Device pacing issue | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block complete | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cardiac discomfort | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Device capturing issue | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Device pacing issue | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Incision site infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Incision site haematoma | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Neurological symptom | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
Generally, contracts allow investigators to publish study results per the protocol and publication plan. Investigators and Participating Institutions will provide any publication of Study Data generated by PI and/or Participating Institution to Medtronic for review prior to submission to determine if confidential information ("CI") is included and to check for technical correctness. Medtronic may not censor/interfere with the publication beyond the extent necessary to protect CI.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Micra CA Study Manager | Medtronic | 800-328-2518 | rs.micracontinuedaccess@medtronic.com |
| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|