Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home Monitoring Guided OAC | Experimental | 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. |
|
| Physician-Directed OAC | Active Comparator | 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:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home Monitoring Guided OAC | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed | 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. | From date of enrollment until date of primary endpoint event, assessed up to study exit, with a mean treatment duration of 2.0 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of All-cause Mortality | Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years | |
| 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 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25908774 | Derived | Martin DT, Bersohn MM, Waldo AL, Wathen MS, Choucair WK, Lip GY, Ip J, Holcomb R, Akar JG, Halperin JL; IMPACT Investigators. Randomized trial of atrial arrhythmia monitoring to guide anticoagulation in patients with implanted defibrillator and cardiac resynchronization devices. Eur Heart J. 2015 Jul 7;36(26):1660-8. doi: 10.1093/eurheartj/ehv115. Epub 2015 Apr 23. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Physician-Directed OAC | Drug | Patients will receive physician-directed anticoagulation therapy based on conventional criteria. OAC drugs used: Dabigatran etexilate, Rivaroxaban, Warfarin, other approved VKA |
|
| 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 |
| Rate of Major Bleeding Events | Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years |
| 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 |
| 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 |
| Change in Quality of Life Score | 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. | 1 year |
| Mean Ventricular Heart Rate Reduction | 1 year |
| Scottsdale |
| Arizona |
| United States |
| Anaheim | California | United States |
| Fremont | California | United States |
| Santa Barbara | California | United States |
| Torrance | California | United States |
| Ventura | California | United States |
| Aurora | Colorado | United States |
| Boulder | Colorado | United States |
| Newark | Delaware | United States |
| Davenport | Florida | United States |
| Daytona Beach | Florida | United States |
| Kissimmee | Florida | United States |
| Melbourne | Florida | United States |
| Sarasota | Florida | United States |
| St. Petersburg | Florida | United States |
| Zephyrhills | Florida | United States |
| Chicago | Illinois | United States |
| Elk Grove Village | Illinois | United States |
| Maywood | Illinois | United States |
| Fort Wayne | Indiana | United States |
| Valparaiso | Indiana | United States |
| Shawnee Mission | Kansas | United States |
| Lexington | Kentucky | United States |
| Louisville | Kentucky | United States |
| Owensboro | Kentucky | United States |
| Hammond | Louisiana | United States |
| Lafayette | Louisiana | United States |
| New Orleans | Louisiana | United States |
| Bangor | Maine | United States |
| Lewiston | Maine | United States |
| Cumberland | Maryland | United States |
| Boston | Massachusetts | United States |
| Burlington | Massachusetts | United States |
| Worcester | Massachusetts | United States |
| Ann Arbor | Michigan | United States |
| Bay City | Michigan | United States |
| Lansing | Michigan | United States |
| Lapeer | Michigan | United States |
| Saginaw | Michigan | United States |
| Ypsilanti | Michigan | United States |
| Minneapolis | Minnesota | United States |
| Tupelo | Mississippi | United States |
| Kansas City | Missouri | United States |
| Osage Beach | Missouri | United States |
| St Louis | Missouri | United States |
| Omaha | Nebraska | United States |
| Ridgewood | New Jersey | United States |
| New York | New York | United States |
| Durham | North Carolina | United States |
| Hickory | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Kettering | Ohio | United States |
| Middletown | Ohio | United States |
| Toledo | Ohio | United States |
| Westlake | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Tulsa | Oklahoma | United States |
| Tualatin | Oregon | United States |
| Abington | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Phoenixville | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Greenville | South Carolina | United States |
| Rock Hill | South Carolina | United States |
| Cookeville | Tennessee | United States |
| Germantown | Tennessee | United States |
| Nashville | Tennessee | United States |
| Corpus Christi | Texas | United States |
| Houston | Texas | United States |
| Humble | Texas | United States |
| Kingwood | Texas | United States |
| Wahroonga | Australia |
| Montreal | Quebec | Canada |
| Sherbrooke | Quebec | Canada |
| Aarhus | Denmark |
| Tübingen | Germany |
| Villingen | Germany |
| Birmingham | United Kingdom |
| FG001 |
| 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled subjects
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed | 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. | Intent to treat analysis of all enrolled subjects | Posted | Number | percentage of participants-Kaplan Meier | From date of enrollment until date of primary endpoint event, assessed up to study exit, with a mean treatment duration of 2.0 years |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rates of All-cause Mortality | Posted | Count of Participants | Participants | Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Ischemic and Hemorrhagic Stroke | Posted | Count of Participants | Participants | Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Fatal or Disabling and Non-disabling Stroke | Posted | Count of Participants | Participants | Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Major Bleeding Events | Posted | Count of Participants | Participants | Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Atrial Fibrillation/Atrial Flutter Burden | Posted | Mean | Standard Deviation | percent daily burden | Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Cardioembolic and Non-cardioembolic Stroke | Posted | Count of Participants | Participants | Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Quality of Life Score | 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. | Subjects with paired baseline and 1 year Quality of Life scores | Posted | Mean | Standard Deviation | Scores on a scale | 1 year |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Ventricular Heart Rate Reduction | Subjects with baseline and 1 year ventricular rate information | Posted | Mean | Standard Deviation | beats per minute | 1 year |
|
|
Study duration from date of enrollment to date of study exit, with a mean implant duration of 2.0 years
Data for serious adverse event subcategories with an incidence of less than 1.0% are not shown. Patients could have more than one event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 372 | 1,357 | 135 | 1,357 | ||
| EG001 | 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. | 374 | 1,361 | 139 | 1,361 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congestive heart failure | Cardiac disorders | With hospitalization |
| ||
| Arrhythmia | Cardiac disorders | With hospitalization |
| ||
| Angina | Cardiac disorders | With hospitalization |
| ||
| Dyspnea | Cardiac disorders | With hospitalization |
| ||
| Coronary artery disease | Cardiac disorders | With hospitalization |
| ||
| Myocardial infaction | Cardiac disorders | With hospitalization |
| ||
| Cardiac arrest | Cardiac disorders | With hospitalization or resulting in death |
| ||
| Stroke | Nervous system disorders | With hospitalization, resulting in death, or persistent/significant disability |
| ||
| Gastrointestianal bleeding | Vascular disorders | With hospitalization or results in death |
| ||
| Upgrade to CRT-D device | Surgical and medical procedures | With hospitalization |
| ||
| Device replacement | Surgical and medical procedures | With hospitalization |
| ||
| Lead replacement or repositioning | Surgical and medical procedures | With hospitalization |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congestive Heart Failure | Cardiac disorders | Not requiring hospitalization |
| ||
| Arrhythmia | Cardiac disorders | Not requiring hospitalization |
| ||
| Angina | Cardiac disorders | Not requiring hospitalization |
| ||
| Dyspnea | Cardiac disorders | Not requiring hospitalization |
| ||
| Device replacement | Surgical and medical procedures | 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.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Crystal Miller | Biotronik, Inc | 503-451-8051 | crystal.miller@biotronik.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| D020521 | Stroke |
| D004617 | Embolism |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D016769 | Embolism and Thrombosis |
Not provided
Not provided
| Male |
|
| Kaplan-Meier estimate at 3 Years |
|
| Kaplan-Meier estimate at 4 Years |
|
| Kaplan-Meier estimate at 5 Years |
|
|
|
|
|
|
|
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.
|
|
|