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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

  Participant Flow

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

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 
Overall Participants Analyzed 
[Units: Participants]
 		 1357   1361   2718 
Age 
[Units: Years]
Mean (Standard Deviation) 		 64.7  (10.8)   64.2  (11.5)   64.4  (11.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      347  25.6%      368  27.0%      715  26.3% 
Male      1010  74.4%      993  73.0%      2003  73.7% 


  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   [ Time Frame: Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years ]
  Show Outcome Measure 2

3.  Secondary:   Rate of Ischemic and Hemorrhagic Stroke   [ Time Frame: Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years ]
  Show Outcome Measure 3

4.  Secondary:   Rate of Fatal or Disabling and Non-disabling Stroke   [ Time Frame: Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years ]
  Show Outcome Measure 4

5.  Secondary:   Rate of Major Bleeding Events   [ Time Frame: Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years ]
  Show Outcome Measure 5

6.  Secondary:   Mean Atrial Fibrillation/Atrial Flutter Burden   [ Time Frame: Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years ]
  Show Outcome Measure 6

7.  Secondary:   Rate of Cardioembolic and Non-cardioembolic Stroke   [ Time Frame: Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years ]
  Show Outcome Measure 7

8.  Secondary:   Change in Quality of Life Score   [ Time Frame: 1 year ]
  Show Outcome Measure 8

9.  Secondary:   Mean Ventricular Heart Rate Reduction   [ Time Frame: 1 year ]
  Show Outcome Measure 9


  Serious Adverse Events


  Other Adverse Events


  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
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.


  More Information

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


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
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