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This study is a multi-center, prospective and randomized trial. The primary objective of this study is to demonstrate that the use of the BIOTRONIK Home Monitoring system (HM) can safely reduce the number of regularly scheduled office follow-up visits, compared to the conventional method of implantable cardioverter defibrillator (ICD) follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home Monitoring | Active Comparator | Home Monitoring programmed on. |
|
| In-Office Conventional Follow-up | Other | Home Monitoring programmed off. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home Monitoring | Other | Home Monitoring programmed on. In-office and Home Monitoring evaluation at 3 and 15 months post ICD implant. Home Monitoring evaluation only at 6, 9, and 12 months post ICD implant. |
| Measure | Description | Time Frame |
|---|---|---|
| Home Monitoring Effectiveness | Average number of office-based implantable cardioverter defibrillator (ICD) follow-up visits in the Home Monitoring arm vs the Conventional (calendar-based) follow-up arm. | 12 months |
| Percent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention. | Percentage of participants experiencing death, incidence of stroke, or event(s) requiring surgical intervention. Outcome measure time frame is 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Early Detection of Cardiac Events | Detection time relative to onset of cardiac events (atrial fibrillation, ventricular tachycardia, ventricular fibrillation). | 12 months |
| Patient Initiated Follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niraj Varma, MD, FRCP | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 55 | Birmingham | Alabama | 35294 | United States | ||
| Site 68 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20625110 | Result | Varma N, Epstein AE, Irimpen A, Schweikert R, Love C; TRUST Investigators. Efficacy and safety of automatic remote monitoring for implantable cardioverter-defibrillator follow-up: the Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) trial. Circulation. 2010 Jul 27;122(4):325-32. doi: 10.1161/CIRCULATIONAHA.110.937409. Epub 2010 Jul 12. | |
| 36503177 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Home Monitoring | Home Monitoring programmed ON |
| FG001 | Conventional | Home Monitoring programmed OFF |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| In-Office Conventional Follow-up | Other | Home Monitoring programmed off. In-office evaluations at 3, 6, 9, 12, and 15 months post ICD implant. |
|
Percentage of total patient initiated inqueries that result in ER or office follow-up visits.
| 12 months |
| Mesa |
| Arizona |
| 85205 |
| United States |
| Site 99 | Phoenix | Arizona | 85016 | United States |
| Site 118 | Bakersfield | California | 93301 | United States |
| Site 91 | Bakersfield | California | 93301 | United States |
| Site 95 | Burbank | California | 91505 | United States |
| Site 72 | Fairfield | California | 94533 | United States |
| Site 43 | Fremont | California | 94568 | United States |
| Site 90 | Fresno | California | 93701 | United States |
| Site 73 | Fresno | California | 93720 | United States |
| Site 75 | Fresno | California | 93720 | United States |
| Site 67 | Glendale | California | 91203 | United States |
| Site 82 | Jackson | California | 95642 | United States |
| Site 78 | Mission Viejo | California | 92691 | United States |
| Site 15 | Sherman Oaks | California | 91403 | United States |
| Site 89 | Simi Valley | California | 93065 | United States |
| Site 88 | Whittier | California | 90603 | United States |
| Site 37 | Boulder | Colorado | 80304 | United States |
| Site 38 | Boulder | Colorado | 80304 | United States |
| Site 98 | Denver | Colorado | 80210 | United States |
| Site 122 | Newark | Delaware | 19713 | United States |
| Site 100 | Brooksville | Florida | 34613 | United States |
| Site 111 | Jacksonville | Florida | 32207 | United States |
| Site 40 | Lakeland | Florida | 33803 | United States |
| Site 36 | Lauderdale Lakes | Florida | 33313 | United States |
| Site 34 | Miami | Florida | 33176 | United States |
| Site 42 | Oakland Park | Florida | 33334 | United States |
| Site 13 | Port Charlotte | Florida | 33952 | United States |
| Site 41 | Tamarac | Florida | 33321 | United States |
| Site 60 | Vero Beach | Florida | 32960 | United States |
| Site 6 | Canton | Georgia | 30114 | United States |
| Site 106 | Douglas | Georgia | 31533 | United States |
| Site 61 | Lawrenceville | Georgia | 30045 | United States |
| Site 10 | Marietta | Georgia | 30060 | United States |
| Site 66 | Marietta | Georgia | 30060 | United States |
| Site 21 | Chicago | Illinois | 60153 | United States |
| Site 124 | Chicago | Illinois | 60657 | United States |
| Site 39 | Oak Lawn | Illinois | 60453 | United States |
| Site 3 | Louisville | Kentucky | 40215 | United States |
| Site 11 | Owensboro | Kentucky | 42303 | United States |
| Site 51 | Covington | Louisiana | 70433 | United States |
| Site 79 | Hammond | Louisiana | 70403 | United States |
| Site 85 | Lacombe | Louisiana | 70445 | United States |
| Site 102 | Lafayette | Louisiana | 70503 | United States |
| Site 2 | Lake Charles | Louisiana | 70601 | United States |
| Site 53 | New Orleans | Louisiana | 70112 | United States |
| Site 17 | Annapolis | Maryland | 21401 | United States |
| Site 25 | Lanham | Maryland | 20706 | United States |
| Site 17 | Riverdale | Maryland | 20737 | United States |
| Site 18 | Rockville | Maryland | 20852 | United States |
| Site 29 | Boston | Massachusetts | 02135 | United States |
| Site 94 | Ann Arbor | Michigan | 48109-0273 | United States |
| Site 103 | Bloomfield Hills | Michigan | 48302 | United States |
| Site 4 | Lansing | Michigan | 48910 | United States |
| Site 12 | Lapeer | Michigan | 48446 | United States |
| Site 22 | Saginaw | Michigan | 48601 | United States |
| Site 14 | Corinth | Mississippi | 38834 | United States |
| Site 52 | Gulfport | Mississippi | 39503 | United States |
| Site 49 | Bridgeton | Missouri | 63044 | United States |
| Site 105 | Festus | Missouri | 63028 | United States |
| Site 121 | Festus | Missouri | 63028 | United States |
| Site 45 | Moberly | Missouri | 65270 | United States |
| Site 56 | Osage Beach | Missouri | 65065 | United States |
| Site 108 | St Louis | Missouri | 63103 | United States |
| Site 114 | St Louis | Missouri | 63117 | United States |
| Site 48 | St Louis | Missouri | 63128 | United States |
| Site 113 | St Louis | Missouri | 63131 | United States |
| Site 74 | St Louis | Missouri | 63131 | United States |
| Site 47 | University City | Missouri | 63130 | United States |
| Site 117 | Brick | New Jersey | 08724 | United States |
| Site 120 | East Brunswick | New Jersey | 08816 | United States |
| Site 107 | East Orange | New Jersey | 07019 | United States |
| Site 119 | Elizabeth | New Jersey | 07202 | United States |
| Site 116 | Oakhurst | New Jersey | 07755 | United States |
| Site 71 | Wayne | New Jersey | 07470 | United States |
| Site 97 | Las Cruces | New Mexico | 88011 | United States |
| Site 112 | Batavia | New York | 14020 | United States |
| Site 19 | Brooklyn | New York | 11203 | United States |
| Site 27 | Brooklyn | New York | 11203 | United States |
| Site 26 | Brooklyn | New York | 11209 | United States |
| Site 77 | Brooklyn | New York | 11223 | United States |
| Site 9 | Johnson City | New York | 13790 | United States |
| Site 35 | New York | New York | 10021 | United States |
| Site 76 | New York | New York | 10028 | United States |
| Site 115 | Pinehurst | North Carolina | 28374 | United States |
| Site 57 | Cleveland | Ohio | 44195 | United States |
| Site 16 | Columbus | Ohio | 43210 | United States |
| Site 50 | Columbus | Ohio | 43228 | United States |
| Site 84 | Fairview Park | Ohio | 44129 | United States |
| Site 93 | Massillon | Ohio | 44646 | United States |
| Site 30 | Middletown | Ohio | 45042 | United States |
| Site 87 | Middletown | Ohio | 45042 | United States |
| Site 96 | Tulsa | Oklahoma | 74136 | United States |
| Site 63 | Chinchilla | Pennsylvania | 18410 | United States |
| Site 62 | Clarks Summit | Pennsylvania | 18411 | United States |
| Site 32 | Upland | Pennsylvania | 19013 | United States |
| Site 23 | Columbia | South Carolina | 29204 | United States |
| Site 20 | Florence | South Carolina | 29506 | United States |
| Site 109 | Lancaster | South Carolina | 29720 | United States |
| Site 5 | Rock Hill | South Carolina | 29732 | United States |
| Site 59 | Knoxville | Tennessee | 37923 | United States |
| Site 8 | Knoxville | Tennessee | 37923 | United States |
| Site 110 | Tullahoma | Tennessee | 37388 | United States |
| Site 1 | Amarillo | Texas | 79106 | United States |
| Site 81 | Brownsville | Texas | 78520 | United States |
| Site 33 | Odessa | Texas | 79761 | United States |
| Site 80 | San Antonio | Texas | 78229 | United States |
| Site 7 | Yakima | Washington | 98902 | United States |
| Site 104 | Toronto | Ontario | Canada |
| Site 92 | Fleurimont | Quebec | Canada |
| Chew DS, Piccini JP, Au F, Frazier-Mills CG, Michalski J, Varma N; TRUST Investigators. Alert-driven vs scheduled remote monitoring of implantable cardiac defibrillators: A cost-consequence analysis from the TRUST trial. Heart Rhythm. 2023 Mar;20(3):440-447. doi: 10.1016/j.hrthm.2022.12.003. Epub 2022 Dec 8. |
| 33640345 | Derived | Varma N, Love CJ, Michalski J, Epstein AE; TRUST Investigators. Alert-Based ICD Follow-Up: A Model of Digitally Driven Remote Patient Monitoring. JACC Clin Electrophysiol. 2021 Aug;7(8):976-987. doi: 10.1016/j.jacep.2021.01.008. Epub 2021 Feb 24. |
| 29016878 | Derived | Varma N, Love CJ, Schweikert R, Moll P, Michalski J, Epstein AE; TRUST Investigators. Automatic remote monitoring utilizing daily transmissions: transmission reliability and implantable cardioverter defibrillator battery longevity in the TRUST trial. Europace. 2018 Apr 1;20(4):622-628. doi: 10.1093/europace/eux059. |
| 26661687 | Derived | Varma N, Epstein AE, Schweikert R, Michalski J, Love CJ; TRUST Investigators. Role of Automatic Wireless Remote Monitoring Immediately Following ICD Implant: The Lumos-T Reduces Routine Office Device Follow-Up Study (TRUST) Trial. J Cardiovasc Electrophysiol. 2016 Mar;27(3):321-6. doi: 10.1111/jce.12895. Epub 2016 Jan 27. |
| 24595864 | Derived | Varma N, Michalski J, Stambler B, Pavri BB; TRUST Investigators. Superiority of automatic remote monitoring compared with in-person evaluation for scheduled ICD follow-up in the TRUST trial - testing execution of the recommendations. Eur Heart J. 2014 May 21;35(20):1345-52. doi: 10.1093/eurheartj/ehu066. Epub 2014 Mar 3. |
| 23258817 | Derived | Varma N, Pavri BB, Stambler B, Michalski J; TRUST Investigators. Same-day discovery of implantable cardioverter defibrillator dysfunction in the TRUST remote monitoring trial: influence of contrasting messaging systems. Europace. 2013 May;15(5):697-703. doi: 10.1093/europace/eus410. Epub 2012 Dec 19. |
| 20716717 | Derived | Varma N, Michalski J, Epstein AE, Schweikert R. Automatic remote monitoring of implantable cardioverter-defibrillator lead and generator performance: the Lumos-T Safely RedUceS RouTine Office Device Follow-Up (TRUST) trial. Circ Arrhythm Electrophysiol. 2010 Oct;3(5):428-36. doi: 10.1161/CIRCEP.110.951962. Epub 2010 Aug 17. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Home Monitoring | Home Monitoring programmed ON |
| BG001 | Conventional | Home Monitoring programmed OFF |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Only participants who completed at least one follow-up visit are included in the analyses. Home Monitoring Arm, N=908; Conventional Arm, N=431. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Only participants who completed at least one follow-up visit are included in the analyses. Home Monitoring Arm, N=908; Conventional Arm, N=431. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Only participants who completed at least one follow-up visit are included in the analyses. Home Monitoring Arm, N=908; Conventional Arm, N=431. | 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 | Home Monitoring Effectiveness | Average number of office-based implantable cardioverter defibrillator (ICD) follow-up visits in the Home Monitoring arm vs the Conventional (calendar-based) follow-up arm. | Only participants who completed at least one follow-up visit are included in the analyses. | Posted | Mean | Full Range | In-office ICD follow-up per patient year | 12 months |
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| Primary | Percent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention. | Percentage of participants experiencing death, incidence of stroke, or event(s) requiring surgical intervention. Outcome measure time frame is 12 months. | Safety Event Rate includes events occuring within 12 months of enrollment for participants with at least 1 follow-up. | Posted | Number | Percentage of participants | 12 months |
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| Secondary | Early Detection of Cardiac Events | Detection time relative to onset of cardiac events (atrial fibrillation, ventricular tachycardia, ventricular fibrillation). | Only participants with at least one follow-up are included in the analyses. | Posted | Mean | Full Range | Days | 12 months |
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| Secondary | Patient Initiated Follow-up | Percentage of total patient initiated inqueries that result in ER or office follow-up visits. | Only participants with at least one follow-up are included in the analyses | Posted | Number | percent of patient initiated follow-ups | 12 months |
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15 Months
Strokes or complications that lead to a surgical intervention were required to be reported. Complications that led to a surgical intervention include but are not limited to a lead revision, cardiac interventional procedure, or device replacement. Other AEs were reported at the discretion of the investigator and may include non-cardiac events.
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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 | Home Monitoring | Home Monitoring programmed ON | 124 | 977 | 0 | 977 | ||
| EG001 | Conventional | Home Monitoring programmed OFF | 74 | 473 | 0 | 473 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ablation procedure | Surgical and medical procedures | Systematic Assessment |
| ||
| Aborted upgrade procedure | Surgical and medical procedures | Systematic Assessment |
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| Cardiac related hospitalizations | Cardiac disorders | Systematic Assessment |
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| Catheterization/PCI procedure | Surgical and medical procedures | Systematic Assessment |
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| Coronary artery bypass graft procedure | Surgical and medical procedures | Systematic Assessment |
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| Death | General disorders | Systematic Assessment |
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| Device change-out | Surgical and medical procedures | Systematic Assessment |
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| Device revision | Surgical and medical procedures | Systematic Assessment |
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| Heart transplant | Surgical and medical procedures | Systematic Assessment |
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| IVC filter implanted | Surgical and medical procedures | Systematic Assessment |
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| LV assist device implanted | Surgical and medical procedures | Systematic Assessment |
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| Lead revision/explant/replacement | Surgical and medical procedures | Systematic Assessment |
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| Non-cardiac related hospitalizations | General disorders | Systematic Assessment |
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| Non-cardiac surgical interventions | Surgical and medical procedures | Systematic Assessment |
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| Permacath for dialysis and endoscopy | Surgical and medical procedures | Systematic Assessment |
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| Tighten loose set screw | Surgical and medical procedures | Systematic Assessment |
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The investigator agrees to provide copies of any abstracts, papers or manuscripts to the Sponsor for review within a reasonable period prior to submittal for publication. BIOTRONIK limits its review to a determination of whether Confidential Information (CI) is disclosed and may not attempt to censor or in any way interfere with the investigator's presentation or conclusions beyond the extent necessary to protect CI or to allow to protect its rights in patentable or copyrightable material.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Justin Michalski, M.S. / Clinical Studies Engineer | Biotronik, Inc. | 503-675-2155 | justin.michalski@biotronik.com |
| ID | Term |
|---|---|
| D015190 | Blood Glucose Self-Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D000085263 | Self-Testing |
| D012648 | Self Care |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| Canada |
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