Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk (IMPACT)
This study has been terminated.
Sponsor:
Biotronik, Inc.
Information provided by (Responsible Party):
Biotronik, Inc.
ClinicalTrials.gov Identifier:
NCT00559988
First received: November 15, 2007
Last updated: June 23, 2014
Last verified: June 2014
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Results First Received: May 20, 2014
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Investigator); Primary Purpose: Prevention |
| Conditions: |
Atrial Fibrillation Atrial Flutter Stroke Embolism, Systemic Arterial Major Bleeding |
| Interventions: |
Drug: Home Monitoring Guided OAC Drug: Physician-Directed OAC |
Participant Flow
Hide Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Home Monitoring Guided OAC | Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy. |
| Physician-Directed OAC | In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care. |
Participant Flow: Overall Study
| Home Monitoring Guided OAC | Physician-Directed OAC | |
|---|---|---|
| STARTED | 1357 | 1361 |
| COMPLETED | 1006 | 1009 |
| NOT COMPLETED | 351 | 352 |
| Death | 147 | 140 |
| Withdrawal by Subject | 152 | 139 |
| Lost to Follow-up | 42 | 56 |
| ICD device explanted | 10 | 17 |
Baseline Characteristics
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| All enrolled subjects |
Reporting Groups
| Description | |
|---|---|
| Home Monitoring Guided OAC | Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy. |
| Physician-Directed OAC | In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care. |
| Total | Total of all reporting groups |
Baseline Measures
| Home Monitoring Guided OAC | Physician-Directed OAC | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
1357 | 1361 | 2718 |
|
Age
[units: years] Mean (Standard Deviation) |
64.7 (10.8) | 64.2 (11.5) | 64.4 (11.2) |
|
Gender
[units: participants] |
|||
| Female | 347 | 368 | 715 |
| Male | 1010 | 993 | 2003 |
Outcome Measures
| 1. Primary: | Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed [ Time Frame: From date of enrollment until date of primary endpoint event, assessed up to study exit, with a mean treatment duration of 2.0 years ] |
Show Outcome Measure 1
| 2. Secondary: | Rates of All-cause Mortality, Stroke (Ischemic and Hemorrhagic, Disabling and Non-disabling, Cardioembolic and Non-cardioembolic), and Major Bleeding, as Well as the AF Burden, Quality of Life, and Mean Heart Rate Reduction. [ Time Frame: 3 years ] |
Results not yet reported. Anticipated Reporting Date:
No text entered.
Safety Issue:
No
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| This study was stopped early when the primary endpoint met futility criteria. Continuation might possibly have changed the outcome; however, it was unlikely to demonstrate a meaningful clinical benefit for the intervention under investigation. |
More Information
Certain Agreements:
Results Point of Contact:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Results Point of Contact:
Name/Title: Crystal Miller
Organization: Biotronik, Inc
phone: 503-451-8051
e-mail: crystal.miller@biotronik.com
Organization: Biotronik, Inc
phone: 503-451-8051
e-mail: crystal.miller@biotronik.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Biotronik, Inc. |
| ClinicalTrials.gov Identifier: | NCT00559988 History of Changes |
| Other Study ID Numbers: |
IMPACT |
| Study First Received: | November 15, 2007 |
| Results First Received: | May 20, 2014 |
| Last Updated: | June 23, 2014 |
| Health Authority: | United States: Institutional Review Board |