Trial · NCT00559988
Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
NCT00559988, Phase 4, Terminated, Biotronik, Inc.; results first posted 2014-06-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk. Trials, record NCT00559988. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00559988
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
- NCT number
- NCT00559988
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 2,718 participants, actual
- Lead sponsor
- Biotronik, Inc.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Stroke, Embolism, Systemic Arterial, Major Bleeding
- Interventions
- Home Monitoring Guided OAC, Physician-Directed OAC
- First posted
- 2007-11-19
- Last updated
- 2017-12-05
- Results first posted
- 2014-06-23
- Limitations and caveats
Study stopped early when primary endpoint met futility criteria. Continuation may have changed the outcome; however, unlikely to demonstrate a meaningful clinical benefit. Interpretation of secondary endpoints should be approached with caution.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed | From date of enrollment until date of primary endpoint event, assessed up to study exit, with a mean treatment duration of 2.0 years | The primary endpoint is to demonstrate whether early detection of atrial arrhythmias based on BIOTRONIK Home Monitoring technology combined with a predefined anticoagulation plan in the Home Monitoring Guided OAC group is superior to the Physician-Directed OAC group reflecting conventional care and physician directed treatment of AF in terms of risk reduction of the primary composite endpoint including stroke, systemic embolism, and major bleeding events. |
| Secondary | Rates of All-cause Mortality | Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years | |
| Secondary | Rate of Ischemic and Hemorrhagic Stroke | Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years | |
| Secondary | Rate of Fatal or Disabling and Non-disabling Stroke | Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years | |
| Secondary | Rate of Major Bleeding Events | Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years | |
| Secondary | Mean Atrial Fibrillation/Atrial Flutter Burden | Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years | |
| Secondary | Rate of Cardioembolic and Non-cardioembolic Stroke | Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years | |
| Secondary | Change in Quality of Life Score | 1 year | Quality of Life was evaluated using the SF-36 v2 Health Survey. The SF-36 consists of eight scaled scores which correspond to the following sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are recoded per a scoring key with each question having a value from 0 to 100. Scores from items in the same scale are averaged together per the scoring key to create the section and subsection (physical health and mental health) scores. For all reported scores, the lowest possible value is 0 (representing the highest disability) and the highest possible value is 100 (representing no disability). Therefore, a positive change from baseline to 1 year represents an improvement in disability, while a negative change represents a worsening of disability. |
| Secondary | Mean Ventricular Heart Rate Reduction | 1 year |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed | From date of enrollment until date of primary endpoint event, assessed up to study exit, with a mean treatment duration of 2.0 years | Intent to treat analysis of all enrolled subjects | percentage of participants-Kaplan Meier | NUMBER |
| SECONDARY | Rates of All-cause Mortality | Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Rate of Ischemic and Hemorrhagic Stroke | Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Rate of Fatal or Disabling and Non-disabling Stroke | Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Rate of Major Bleeding Events | Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mean Atrial Fibrillation/Atrial Flutter Burden | Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years | percent daily burden | MEAN | |
| SECONDARY | Rate of Cardioembolic and Non-cardioembolic Stroke | Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Quality of Life Score | 1 year | Subjects with paired baseline and 1 year Quality of Life scores | Scores on a scale | MEAN |
| SECONDARY | Mean Ventricular Heart Rate Reduction | 1 year | Subjects with baseline and 1 year ventricular rate information | beats per minute | MEAN |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed | Home Monitoring Guided OAC | Kaplan-Meier estimate at 1 Year | 97.5 | percentage of participants-Kaplan Meier | |
| Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed | Physician-Directed OAC | Kaplan-Meier estimate at 1 Year | 97.7 | percentage of participants-Kaplan Meier | |
| Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed | Home Monitoring Guided OAC | Kaplan-Meier estimate at 2 Years | 94.8 | percentage of participants-Kaplan Meier | |
| Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed | Physician-Directed OAC | Kaplan-Meier estimate at 2 Years | 95.7 | percentage of participants-Kaplan Meier | |
| Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed | Home Monitoring Guided OAC | Kaplan-Meier estimate at 3 Years | 92.3 | percentage of participants-Kaplan Meier | |
| Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed | Physician-Directed OAC | Kaplan-Meier estimate at 3 Years | 92.0 | percentage of participants-Kaplan Meier | |
| Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed | Home Monitoring Guided OAC | Kaplan-Meier estimate at 4 Years | 90.0 | percentage of participants-Kaplan Meier | |
| Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed | Physician-Directed OAC | Kaplan-Meier estimate at 4 Years | 89.4 | percentage of participants-Kaplan Meier | |
| Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed | Home Monitoring Guided OAC | Kaplan-Meier estimate at 5 Years | 86.8 | percentage of participants-Kaplan Meier | |
| Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed | Physician-Directed OAC | Kaplan-Meier estimate at 5 Years | 87.9 | percentage of participants-Kaplan Meier |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Home Monitoring Guided OAC | 1,357 | |
| Overall Study | STARTED | Physician-Directed OAC | 1,361 | |
| Overall Study | COMPLETED | Home Monitoring Guided OAC | 1,006 | |
| Overall Study | COMPLETED | Physician-Directed OAC | 1,009 | |
| Overall Study | NOT COMPLETED | Home Monitoring Guided OAC | 351 | |
| Overall Study | NOT COMPLETED | Physician-Directed OAC | 352 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Congestive Heart Failure | Cardiac disorders | Home Monitoring Guided OAC | 22 | 1,357 | 39 |
| other | Congestive Heart Failure | Cardiac disorders | Physician-Directed OAC | 25 | 1,361 | 51 |
| other | Arrhythmia | Cardiac disorders | Home Monitoring Guided OAC | 52 | 1,357 | 84 |
| other | Arrhythmia | Cardiac disorders | Physician-Directed OAC | 53 | 1,361 | 74 |
| other | Angina | Cardiac disorders | Home Monitoring Guided OAC | 32 | 1,357 | 49 |
| other | Angina | Cardiac disorders | Physician-Directed OAC | 34 | 1,361 | 48 |
| other | Dyspnea | Cardiac disorders | Home Monitoring Guided OAC | 19 | 1,357 | 19 |
| other | Dyspnea | Cardiac disorders | Physician-Directed OAC | 18 | 1,361 | 19 |
| other | Device replacement | Surgical and medical procedures | Home Monitoring Guided OAC | 29 | 1,357 | 29 |
| other | Device replacement | Surgical and medical procedures | Physician-Directed OAC | 35 | 1,361 | 35 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Home Monitoring Guided OAC | ||
| Total, all-cause mortality | Physician-Directed OAC | ||
| Total, other adverse events | Home Monitoring Guided OAC | 135 | 1,357 |
| Total, other adverse events | Physician-Directed OAC | 139 | 1,361 |
| Total, serious adverse events | Home Monitoring Guided OAC | 372 | 1,357 |
| Total, serious adverse events | Physician-Directed OAC | 374 | 1,361 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25908774 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Home Monitoring Guided OAC vs Physician-Directed OAC: Rates of All-cause Mortality | Trial comparisons |
| Home Monitoring Guided OAC vs Physician-Directed OAC: Rate of Major Bleeding Events | Trial comparisons |
| Home Monitoring Guided OAC vs Physician-Directed OAC: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00559988
GET https://conductscience.org/api/trials/v1/NCT00559988/results?page=2