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

History of Changes

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
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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 ]

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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

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Other Adverse Events

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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

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