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Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk (IMPACT)

This study has been terminated.
Sponsor:
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
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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
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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 ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
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


No publications provided


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