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

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ClinicalTrials.gov Identifier: NCT00559988
Recruitment Status : Terminated
First Posted : November 19, 2007
Results First Posted : June 23, 2014
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (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
Enrollment 2718
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Home Monitoring Guided OAC Physician-Directed OAC
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 1357 1361
Completed 1006 1009
Not Completed 351 352
Reason Not Completed
Death             147             140
Withdrawal by Subject             152             139
Lost to Follow-up             42             56
ICD device explanted             10             17
Arm/Group Title Home Monitoring Guided OAC Physician-Directed OAC Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 1357 1361 2718
Hide Baseline Analysis Population Description
All enrolled subjects
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1357 participants 1361 participants 2718 participants
64.7  (10.8) 64.2  (11.5) 64.4  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1357 participants 1361 participants 2718 participants
Female
347
  25.6%
368
  27.0%
715
  26.3%
Male
1010
  74.4%
993
  73.0%
2003
  73.7%
1.Primary Outcome
Title Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis of all enrolled subjects
Arm/Group Title Home Monitoring Guided OAC Physician-Directed OAC
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 1357 1361
Measure Type: Number
Unit of Measure: percentage of participants-Kaplan Meier
Kaplan-Meier estimate at 1 Year 97.5 97.7
Kaplan-Meier estimate at 2 Years 94.8 95.7
Kaplan-Meier estimate at 3 Years 92.3 92.0
Kaplan-Meier estimate at 4 Years 90.0 89.4
Kaplan-Meier estimate at 5 Years 86.8 87.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Home Monitoring Guided OAC, Physician-Directed OAC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.732
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.064
Confidence Interval (2-Sided) 95%
0.75 to 1.51
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Rates of All-cause Mortality
Hide Description [Not Specified]
Time Frame Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Monitoring Guided OAC Physician-Directed OAC
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 1357 1361
Measure Type: Count of Participants
Unit of Measure: Participants
147
  10.8%
140
  10.3%
3.Secondary Outcome
Title Rate of Ischemic and Hemorrhagic Stroke
Hide Description [Not Specified]
Time Frame Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Monitoring Guided OAC Physician-Directed OAC
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 1357 1361
Measure Type: Count of Participants
Unit of Measure: Participants
Ischemic stroke
22
   1.6%
28
   2.1%
Hemorrhagic stroke
3
   0.2%
3
   0.2%
4.Secondary Outcome
Title Rate of Fatal or Disabling and Non-disabling Stroke
Hide Description [Not Specified]
Time Frame Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Monitoring Guided OAC Physician-Directed OAC
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 1357 1361
Measure Type: Count of Participants
Unit of Measure: Participants
Fatal or disabling stroke
9
   0.7%
11
   0.8%
Non-disabling stroke
15
   1.1%
19
   1.4%
5.Secondary Outcome
Title Rate of Major Bleeding Events
Hide Description [Not Specified]
Time Frame Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Monitoring Guided OAC Physician-Directed OAC
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 1357 1361
Measure Type: Count of Participants
Unit of Measure: Participants
46
   3.4%
34
   2.5%
6.Secondary Outcome
Title Mean Atrial Fibrillation/Atrial Flutter Burden
Hide Description [Not Specified]
Time Frame Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Monitoring Guided OAC Physician-Directed OAC
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 1357 1361
Mean (Standard Deviation)
Unit of Measure: percent daily burden
1.3  (8.2) 1.2  (7.4)
7.Secondary Outcome
Title Rate of Cardioembolic and Non-cardioembolic Stroke
Hide Description [Not Specified]
Time Frame Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Monitoring Guided OAC Physician-Directed OAC
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 1357 1361
Measure Type: Count of Participants
Unit of Measure: Participants
Cardiogenic embolism
9
   0.7%
7
   0.5%
Non-cardiogenic
5
   0.4%
8
   0.6%
8.Secondary Outcome
Title Change in Quality of Life Score
Hide Description 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.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with paired baseline and 1 year Quality of Life scores
Arm/Group Title Home Monitoring Guided OAC Physician-Directed OAC
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 886 889
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Physical health summary 1.3  (8.8) 0.9  (8.8)
Mental health summary 1.9  (11.0) 1.6  (11.2)
9.Secondary Outcome
Title Mean Ventricular Heart Rate Reduction
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with baseline and 1 year ventricular rate information
Arm/Group Title Home Monitoring Guided OAC Physician-Directed OAC
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 877 878
Mean (Standard Deviation)
Unit of Measure: beats per minute
0.07  (6.31) -0.34  (5.90)
Time Frame Study duration from date of enrollment to date of study exit, with a mean implant duration of 2.0 years
Adverse Event Reporting Description Data for serious adverse event subcategories with an incidence of less than 1.0% are not shown. Patients could have more than one event.
 
Arm/Group Title Home Monitoring Guided OAC Physician-Directed OAC
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Home Monitoring Guided OAC Physician-Directed OAC
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Home Monitoring Guided OAC Physician-Directed OAC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   372/1357 (27.41%)      374/1361 (27.48%)    
Cardiac disorders     
Congestive heart failure [1]  136/1357 (10.02%)  229 127/1361 (9.33%)  222
Arrhythmia [1]  64/1357 (4.72%)  81 63/1361 (4.63%)  77
Angina [1]  42/1357 (3.10%)  60 53/1361 (3.89%)  65
Dyspnea [1]  17/1357 (1.25%)  20 26/1361 (1.91%)  26
Coronary artery disease [1]  28/1357 (2.06%)  31 18/1361 (1.32%)  21
Myocardial infaction [1]  26/1357 (1.92%)  30 35/1361 (2.57%)  39
Cardiac arrest [2]  23/1357 (1.69%)  24 27/1361 (1.98%)  27
Nervous system disorders     
Stroke [3]  22/1357 (1.62%)  25 30/1361 (2.20%)  31
Surgical and medical procedures     
Upgrade to CRT-D device [1]  25/1357 (1.84%)  26 18/1361 (1.32%)  18
Device replacement [1]  15/1357 (1.11%)  15 9/1361 (0.66%)  9
Lead replacement or repositioning [1]  16/1357 (1.18%)  17 11/1361 (0.81%)  12
Vascular disorders     
Gastrointestianal bleeding [4]  23/1357 (1.69%)  25 18/1361 (1.32%)  19
[1]
With hospitalization
[2]
With hospitalization or resulting in death
[3]
With hospitalization, resulting in death, or persistent/significant disability
[4]
With hospitalization or results in death
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Home Monitoring Guided OAC Physician-Directed OAC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   135/1357 (9.95%)      139/1361 (10.21%)    
Cardiac disorders     
Congestive Heart Failure [1]  22/1357 (1.62%)  39 25/1361 (1.84%)  51
Arrhythmia [1]  52/1357 (3.83%)  84 53/1361 (3.89%)  74
Angina [1]  32/1357 (2.36%)  49 34/1361 (2.50%)  48
Dyspnea [1]  19/1357 (1.40%)  19 18/1361 (1.32%)  19
Surgical and medical procedures     
Device replacement [2]  29/1357 (2.14%)  29 35/1361 (2.57%)  35
[1]
Not requiring hospitalization
[2]
Done as an outpatient procedure (not requiring hospitalization)
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.
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
Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT00559988     History of Changes
Other Study ID Numbers: IMPACT
First Submitted: November 15, 2007
First Posted: November 19, 2007
Results First Submitted: May 20, 2014
Results First Posted: June 23, 2014
Last Update Posted: December 5, 2017