Clinical trial NCT00559988: Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
Official title: The IMPACT of BIOTRONIK Home Monitoring Guided Anticoagulation on Stroke Risk in Patients With ICD and CRT-D Devices
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Atrial Fibrillation
Atrial Flutter
Stroke
Embolism, Systemic Arterial
Major Bleeding
Keywords: Implanted Cardioverter Defibrillator
Cardiac Resynchronization Therapy Defibrillator
Home Monitoring
Oral Anticoagulation
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2007-11-19
Enrollment: 2718
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed
timeFrame: 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 outcomes:
measure: Rates of All-cause Mortality
timeFrame: Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
measure: Rate of Ischemic and Hemorrhagic Stroke
timeFrame: Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
measure: Rate of Fatal or Disabling and Non-disabling Stroke
timeFrame: Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
measure: Rate of Major Bleeding Events
timeFrame: Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
measure: Mean Atrial Fibrillation/Atrial Flutter Burden
timeFrame: Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
measure: Rate of Cardioembolic and Non-cardioembolic Stroke
timeFrame: Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
measure: Change in Quality of Life Score
timeFrame: 1 year
measure: Mean Ventricular Heart Rate Reduction
timeFrame: 1 year
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Fremont
country: United States
state: California
city: Santa Barbara
country: United States
state: California
city: Torrance
country: United States
state: California
city: Ventura
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Boulder
country: United States
state: Colorado
city: Newark
country: United States
state: Delaware
city: Davenport
country: United States
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Zephyrhills
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Elk Grove Village
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Valparaiso
country: United States
state: Indiana
city: Shawnee Mission
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Owensboro
country: United States
state: Kentucky
city: Hammond
country: United States
state: Louisiana
city: Lafayette
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Bangor
country: United States
state: Maine
city: Lewiston
country: United States
state: Maine
city: Cumberland
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Burlington
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Bay City
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: Lapeer
country: United States
state: Michigan
city: Saginaw
country: United States
state: Michigan
city: Ypsilanti
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Tupelo
country: United States
state: Mississippi
city: Kansas City
country: United States
state: Missouri
city: Osage Beach
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Ridgewood
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Middletown
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Westlake
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Tualatin
country: United States
state: Oregon
city: Abington
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Phoenixville
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Greenville
country: United States
state: South Carolina
city: Rock Hill
country: United States
state: South Carolina
city: Cookeville
country: United States
state: Tennessee
city: Germantown
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Corpus Christi
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Humble
country: United States
state: Texas
city: Kingwood
country: United States
state: Texas
city: Wahroonga
country: Australia
city: Montreal
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Aarhus
country: Denmark
city: Tubingen
country: Germany
city: Villingen
country: Germany
city: Birmingham
country: United Kingdom
Study officials:
affiliation: Mount Sinai Medical Center, New York, NY
name: Jonathan L Halperin, M.D.
role: STUDY_CHAIR
affiliation: Thoracic & Cardiovascular Healthcare Foundation, Lansing, MI
name: John Ip, M.D.
role: STUDY_CHAIR
References:
citation: 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.