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

• Sponsor: Biotronik, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00559988
• Collaborator: (none)
• Enrollment: 2,718
• Locations: 80
• Arms: 2
• Duration (Months): 64
• Patients Per Site: 34
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and physician-directed anticoagulation in patients with implanted dual-chamber defibrillators or cardiac resynchronization therapy devices.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation; Atrial Flutter; Stroke; Embolism, Systemic Arterial; Major Bleeding	Drug: Home Monitoring Guided OAC; Drug: Physician-Directed OAC	Phase 4

Detailed Description

Atrial fibrillation (AF) and atrial flutter (AFL) are common cardiac arrhythmias associated with an increased incidence of stroke in patients with additional risk factors. Oral Anticoagulation (OAC) reduces stroke risk, but because these arrhythmias are frequently intermittent and asymptomatic, start of OAC therapy is often delayed until electrocardiographic documentation is obtained.

Technological advances in implanted dual-chamber cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) devices allow early detection and real time verification of AF/AFL with intracardiac electrograms (IEGM) automatically transmitted to the clinicians. Such remote diagnostic capability might be particularly relevant in patients with asymptomatic AF by allowing timely treatment. Compared to conventional periodic, (e.g., quarterly) office device evaluation, daily remote monitoring may prove superior for diagnosis of AF and prophylactic treatment of thromboembolism.

The start, stop and restart of OAC based on a predefined atrial rhythm-guided strategy in conjunction with a standard risk-stratification scheme could lead to better clinical outcomes compared with conventional clinical care. The study is designed to demonstrate a risk reduction of both thromboembolism proximate to episodes of documented AF/AFL and bleeding potentiated by chronic OAC in the absence of AF. Verification of this premise would impact the clinical practice, providing evidence to physicians for the use of HM to guide OAC in patients with AF/AFL. The results of this study should demonstrate the clinical value of wireless remote surveillance of the cardiac rhythm and may define the critical threshold of AF/AFL burden warranting OAC or antiarrhythmic drug therapy in patients at risk of stroke

Study Design

• Study Type: Interventional
• Actual Enrollment: 2718 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: The IMPACT of BIOTRONIK Home Monitoring Guided Anticoagulation on Stroke Risk in Patients With ICD and CRT-D Devices
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 OAC.	Drug: Home Monitoring Guided OAC; Active monitoring for atrial episodes through the automatic HM notifications (email, fax, short message service) is required. If the total duration over 48 consecutive hours reaches the predefined anticoagulation condition, and AF/AFL diagnosis is confirmed using the IEGM online, the site instructs the patient by telephone to start OAC. Clinicians continue to monitor patients using HM, and if freedom from AF/AFL reaches the predefined interval, stop of OAC therapy is requested over the telephone. Following stop of anticoagulation, any recurrence of AF/AFL requires restart of OAC therapy. OAC drugs used: Dabigatran etexilate, Rivaroxaban, Warfarin, other approved VKA
Active Comparator: 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 OAC consistent with current standards of care. Safety Net data include: ERI/EOS Special Implant Status Implant in Backup Mode (ROM) VT/ VF Detection Inactive Emergency Pacing 250 Ω > RV Pacing Impedance > 1500 Ω Symptomatic VT/VF therapies including both ATP and shock VT/VF storm HM transmission failure >3 days	Drug: Physician-Directed OAC; Patients will receive physician-directed anticoagulation therapy based on conventional criteria. OAC drugs used: Dabigatran etexilate, Rivaroxaban, Warfarin, other approved VKA

Outcome Measures

Primary Outcome Measures

1. Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed [From date of enrollment until date of primary endpoint event, assessed up to study exit, with a mean treatment duration of 2.0 years]

   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.

Secondary Outcome Measures

1. Rates of All-cause Mortality [Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years]

2. Rate of Ischemic and Hemorrhagic Stroke [Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years]

3. Rate of Fatal or Disabling and Non-disabling Stroke [Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years]

4. Rate of Major Bleeding Events [Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years]

5. Mean Atrial Fibrillation/Atrial Flutter Burden [Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years]

6. Rate of Cardioembolic and Non-cardioembolic Stroke [Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years]

7. Change in Quality of Life Score [1 year]

   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.

8. Mean Ventricular Heart Rate Reduction [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• Candidates for implantation of, or already implanted with, a BIOTRONIK Lumax HF-T or DR-T device

• Documented P wave mean amplitude ≥ 1.0 mV (sinus rhythm) or ≥ 0.5 mV (AF) at enrollment, if previously implanted

• CHADS2 risk score ≥ 1

• Able and willing to follow OAC therapy if the indication develops during the course of the trial

• Able to utilize the HM throughout the study

Key Exclusion Criteria:

• Permanent AF

• History of stroke, transient ischemic attack (TIA) or systemic embolism and documented AF or AFL

• Currently requiring OAC therapy for any indication

• Patients who underwent successful AF ablation (sinus rhythm restored) and have not completed a minimum of 3 months of OAC therapy

• Known, current contraindication to use of eligible OAC

• Long QT or Brugada syndrome as the sole indication for device implantation

• Life expectancy less than the expected term of the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Phoenix	Arizona	United States
2		Scottsdale	Arizona	United States
3		Anaheim	California	United States
4		Fremont	California	United States
5		Santa Barbara	California	United States
6		Torrance	California	United States
7		Ventura	California	United States
8		Aurora	Colorado	United States
9		Boulder	Colorado	United States
10		Newark	Delaware	United States
11		Davenport	Florida	United States
12		Daytona Beach	Florida	United States
13		Kissimmee	Florida	United States
14		Melbourne	Florida	United States
15		Saint Petersburg	Florida	United States
16		Sarasota	Florida	United States
17		Zephyrhills	Florida	United States
18		Chicago	Illinois	United States
19		Elk Grove Village	Illinois	United States
20		Maywood	Illinois	United States
21		Fort Wayne	Indiana	United States
22		Valparaiso	Indiana	United States
23		Shawnee Mission	Kansas	United States
24		Lexington	Kentucky	United States
25		Louisville	Kentucky	United States
26		Owensboro	Kentucky	United States
27		Hammond	Louisiana	United States
28		Lafayette	Louisiana	United States
29		New Orleans	Louisiana	United States
30		Bangor	Maine	United States
31		Lewiston	Maine	United States
32		Cumberland	Maryland	United States
33		Boston	Massachusetts	United States
34		Burlington	Massachusetts	United States
35		Worcester	Massachusetts	United States
36		Ann Arbor	Michigan	United States
37		Bay City	Michigan	United States
38		Lansing	Michigan	United States
39		Lapeer	Michigan	United States
40		Saginaw	Michigan	United States
41		Ypsilanti	Michigan	United States
42		Minneapolis	Minnesota	United States
43		Tupelo	Mississippi	United States
44		Kansas City	Missouri	United States
45		Osage Beach	Missouri	United States
46		Saint Louis	Missouri	United States
47		Omaha	Nebraska	United States
48		Ridgewood	New Jersey	United States
49		New York	New York	United States
50		Durham	North Carolina	United States
51		Hickory	North Carolina	United States
52		Cincinnati	Ohio	United States
53		Cleveland	Ohio	United States
54		Kettering	Ohio	United States
55		Middletown	Ohio	United States
56		Toledo	Ohio	United States
57		Westlake	Ohio	United States
58		Oklahoma City	Oklahoma	United States
59		Tulsa	Oklahoma	United States
60		Tualatin	Oregon	United States
61		Abington	Pennsylvania	United States
62		Philadelphia	Pennsylvania	United States
63		Phoenixville	Pennsylvania	United States
64		Pittsburgh	Pennsylvania	United States
65		Greenville	South Carolina	United States
66		Rock Hill	South Carolina	United States
67		Cookeville	Tennessee	United States
68		Germantown	Tennessee	United States
69		Nashville	Tennessee	United States
70		Corpus Christi	Texas	United States
71		Houston	Texas	United States
72		Humble	Texas	United States
73		Kingwood	Texas	United States
74		Wahroonga		Australia
75		Montreal	Quebec	Canada
76		Sherbrooke	Quebec	Canada
77		Aarhus		Denmark
78		Tubingen		Germany
79		Villingen		Germany
80		Birmingham		United Kingdom

Sponsors and Collaborators

• Biotronik, Inc.

Investigators

• Study Chair: Jonathan L Halperin, M.D., Mount Sinai Medical Center, New York, NY
• Study Chair: John Ip, M.D., Thoracic & Cardiovascular Healthcare Foundation, Lansing, MI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biotronik, Inc.
• ClinicalTrials.gov Identifier: NCT00559988
• Other Study ID Numbers: IMPACT
• First Posted: Nov 19, 2007
• Last Update Posted: Dec 5, 2017
• Last Verified: Nov 1, 2017

• Keywords provided by Biotronik, Inc.: Implanted Cardioverter Defibrillator; Cardiac Resynchronization Therapy Defibrillator; Home Monitoring; Oral Anticoagulation
• Additional relevant MeSH terms: Stroke; Atrial Fibrillation; Embolism; Atrial Flutter

Study Results

Participant Flow

Arm/Group Title	Home Monitoring Guided OAC	Physician-Directed OAC
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

Baseline Characteristics

Arm/Group Title	Home Monitoring Guided OAC	Physician-Directed OAC	Total
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 Participants	1357	1361	2718
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.7 (10.8)	64.2 (11.5)	64.4 (11.2)
Sex: Female, Male (Count of Participants)
Female	347 25.6%	368 27%	715 26.3%
Male	1010 74.4%	993 73%	2003 73.7%

Outcome Measures

1. Primary Outcome

Title	Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed
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

Outcome Measure Data

Analysis Population Description

Intent to treat analysis of all enrolled subjects

Arm/Group Title	Home Monitoring Guided OAC	Physician-Directed OAC
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.
Measure Participants	1357	1361
Kaplan-Meier estimate at 1 Year	97.5 7.2%	97.7 7.2%
Kaplan-Meier estimate at 2 Years	94.8 7%	95.7 7%
Kaplan-Meier estimate at 3 Years	92.3 6.8%	92.0 6.8%
Kaplan-Meier estimate at 4 Years	90.0 6.6%	89.4 6.6%
Kaplan-Meier estimate at 5 Years	86.8 6.4%	87.9 6.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Home Monitoring Guided OAC, Physician-Directed OAC
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.732
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.064
	Confidence Interval	(2-Sided) 95%; 0.75 to 1.51
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Home Monitoring Guided OAC	Physician-Directed OAC
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.
Measure Participants	1357	1361
Count of Participants [Participants]	147 10.8%	140 10.3%

3. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Home Monitoring Guided OAC	Physician-Directed OAC
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.
Measure Participants	1357	1361
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
Time Frame	Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Home Monitoring Guided OAC	Physician-Directed OAC
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.
Measure Participants	1357	1361
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
Time Frame	Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Home Monitoring Guided OAC	Physician-Directed OAC
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.
Measure Participants	1357	1361
Count of Participants [Participants]	46 3.4%	34 2.5%

6. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Home Monitoring Guided OAC	Physician-Directed OAC
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.
Measure Participants	1357	1361
Mean (Standard Deviation) [percent daily burden]	1.3 (8.2)	1.2 (7.4)

7. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Home Monitoring Guided OAC	Physician-Directed OAC
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.
Measure Participants	1357	1361
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
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

Outcome Measure Data

Analysis Population Description

Subjects with paired baseline and 1 year Quality of Life scores

Arm/Group Title	Home Monitoring Guided OAC	Physician-Directed OAC
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.
Measure Participants	886	889
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
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Subjects with baseline and 1 year ventricular rate information

Arm/Group Title	Home Monitoring Guided OAC	Physician-Directed OAC
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.
Measure Participants	877	878
Mean (Standard Deviation) [beats per minute]	0.07 (6.31)	-0.34 (5.90)

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Home Monitoring Guided OAC		Physician-Directed OAC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	372/1357 (27.4%)		374/1361 (27.5%)
Cardiac disorders
Congestive heart failure	136/1357 (10%)	229	127/1361 (9.3%)	222
Arrhythmia	64/1357 (4.7%)	81	63/1361 (4.6%)	77
Angina	42/1357 (3.1%)	60	53/1361 (3.9%)	65
Dyspnea	17/1357 (1.3%)	20	26/1361 (1.9%)	26
Coronary artery disease	28/1357 (2.1%)	31	18/1361 (1.3%)	21
Myocardial infaction	26/1357 (1.9%)	30	35/1361 (2.6%)	39
Cardiac arrest	23/1357 (1.7%)	24	27/1361 (2%)	27
Nervous system disorders
Stroke	22/1357 (1.6%)	25	30/1361 (2.2%)	31
Surgical and medical procedures
Upgrade to CRT-D device	25/1357 (1.8%)	26	18/1361 (1.3%)	18
Device replacement	15/1357 (1.1%)	15	9/1361 (0.7%)	9
Lead replacement or repositioning	16/1357 (1.2%)	17	11/1361 (0.8%)	12
Vascular disorders
Gastrointestianal bleeding	23/1357 (1.7%)	25	18/1361 (1.3%)	19
Other (Not Including Serious) Adverse Events
	Home Monitoring Guided OAC		Physician-Directed OAC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	135/1357 (9.9%)		139/1361 (10.2%)
Cardiac disorders
Congestive Heart Failure	22/1357 (1.6%)	39	25/1361 (1.8%)	51
Arrhythmia	52/1357 (3.8%)	84	53/1361 (3.9%)	74
Angina	32/1357 (2.4%)	49	34/1361 (2.5%)	48
Dyspnea	19/1357 (1.4%)	19	18/1361 (1.3%)	19
Surgical and medical procedures
Device replacement	29/1357 (2.1%)	29	35/1361 (2.6%)	35

Limitations/Caveats

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.