A Phase 4 interventional study of Home Monitoring and In-Office Conventional Follow-up in Patient Indicated for an ICD, sponsored by Biotronik, Inc.. Completed at 110 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-08-03.
Sponsored by Biotronik, Inc. · Phase 4, Interventional, and Treatment
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.
Biotronik, Inc. is the lead sponsor of 32 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Home Monitoring programmed on.
Other: Home Monitoring
Home Monitoring programmed off.
Other: In-Office Conventional Follow-up
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.
Home Monitoring programmed off. In-office evaluations at 3, 6, 9, 12, and 15 months post ICD implant.
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.
Time frame: 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.
Time frame: 12 months
Early Detection of Cardiac Events
Detection time relative to onset of cardiac events (atrial fibrillation, ventricular tachycardia, ventricular fibrillation).
Time frame: 12 months
Patient Initiated Follow-up
Percentage of total patient initiated inqueries that result in ER or office follow-up visits.
Time frame: 12 months
| Milestone | Home Monitoring | Conventional |
|---|---|---|
| Started | 977 | 473 |
| Completed | 741 | 322 |
| Not completed | 236 | 151 |
| Withdrew: Death | 52 | 26 |
| Withdrew: Lost to follow-up | 82 | 61 |
| Withdrew: Withdrawal by physician or subject | 102 | 64 |
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.
| In-office ICD follow-up per patient year | Home Monitoring | Conventional |
|---|---|---|
| Home Monitoring Effectiveness | 2.1 (0 to 45.6) | 3.8 (0 to 19.2) |
Percentage of participants experiencing death, incidence of stroke, or event(s) requiring surgical intervention. Outcome measure time frame is 12 months.
| Percentage of participants | Home Monitoring | Conventional |
|---|---|---|
| Percent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention. | 10.4 | 10.4 |
Detection time relative to onset of cardiac events (atrial fibrillation, ventricular tachycardia, ventricular fibrillation).
| Days | Home Monitoring | Conventional |
|---|---|---|
| Early Detection of Cardiac Events | 13.98 (0 to 256) | 45.34 (0 to 287) |
Percentage of total patient initiated inqueries that result in ER or office follow-up visits.
| percent of patient initiated follow-ups | Home Monitoring | Conventional |
|---|---|---|
| Patient Initiated Follow-up | 92.7 | 100 |
Collected over 15 Months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Home Monitoring | — | 124/977 (12.7%) | 0/977 (0%) |
| Conventional | — | 74/473 (15.6%) | 0/473 (0%) |
| Event | Home Monitoring | Conventional |
|---|---|---|
| Cardiac related hospitalizationsCardiac disorders | 45/977 | 31/473 |
| DeathGeneral disorders | 52/977 | 26/473 |
| Device revisionSurgical and medical procedures | 17/977 | 7/473 |
| Lead revision/explant/replacementSurgical and medical procedures | 16/977 | 5/473 |
| Non-cardiac related hospitalizationsGeneral disorders | 16/977 | 3/473 |
| Catheterization/PCI procedureSurgical and medical procedures | 15/977 | 3/473 |
| Ablation procedureSurgical and medical procedures | 5/977 | 4/473 |
| Device change-outSurgical and medical procedures | 8/977 | 3/473 |
| Non-cardiac surgical interventionsSurgical and medical procedures | 7/977 | 3/473 |
| Coronary artery bypass graft procedureSurgical and medical procedures | 3/977 | 0/473 |
| Age Continuous(years) | Home Monitoring | Conventional | Total |
|---|---|---|---|
| Mean | 63 ± 13 | 64 ± 12 | 64 ± 13 |
| Sex: Female, Male(Participants) | Home Monitoring | Conventional | Total |
|---|---|---|---|
| Female | 254 | 116 | 370 |
| Male | 654 | 315 | 969 |
| Region of Enrollment(participants) | Home Monitoring | Conventional | Total |
|---|---|---|---|
| United States | 896 | 425 | 1321 |
| Canada | 12 | 6 | 18 |
Showing the first 100 of 110 sites across 2 countries.
This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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Biotronik, Inc.