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

Terminated

Phase 4 Results

Update History

20 Dec '12
Trial name was updated.
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Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
A location was updated in Phoenix.
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The overall status was removed for Name Unavailable.
A location was updated in Scottsdale.
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The overall status was removed for Name Unavailable.
A location was updated in Anaheim.
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The overall status was removed for Name Unavailable.
A location was updated in Fremont.
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The overall status was removed for Name Unavailable.
A location was updated in Santa Barbara.
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The overall status was removed for Name Unavailable.
A location was updated in Torrance.
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The overall status was removed for Name Unavailable.
A location was updated in Ventura.
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The overall status was removed for Name Unavailable.
A location was updated in Aurora.
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The overall status was removed for Name Unavailable.
A location was updated in Boulder.
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The overall status was removed for Name Unavailable.
A location was updated in Newark.
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The overall status was removed for Name Unavailable.
A location was updated in Davenport.
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The overall status was removed for Name Unavailable.
A location was updated in Daytona Beach.
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The overall status was removed for Name Unavailable.
A location was updated in Kissimmee.
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The overall status was removed for Name Unavailable.
A location was updated in Melbourne.
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The overall status was removed for Name Unavailable.
A location was updated in Sarasota.
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The overall status was removed for Name Unavailable.
A location was updated in St. Petersburg.
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The overall status was removed for Name Unavailable.
A location was updated in Zephyrhills.
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The overall status was removed for Name Unavailable.
A location was updated in Chicago.
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The overall status was removed for Name Unavailable.
A location was updated in Elk Grove Village.
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The overall status was removed for Name Unavailable.
A location was updated in Maywood.
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The overall status was removed for Name Unavailable.
A location was updated in Fort Wayne.
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The overall status was removed for Name Unavailable.
A location was updated in Valparaiso.
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The overall status was removed for Name Unavailable.
A location was updated in Shawnee Mission.
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The overall status was removed for Name Unavailable.
A location was updated in Lexington.
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The overall status was removed for Name Unavailable.
A location was updated in Louisville.
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The overall status was removed for Name Unavailable.
A location was updated in Owensboro.
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The overall status was removed for Name Unavailable.
A location was updated in Hammond.
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The overall status was removed for Name Unavailable.
A location was updated in Lafayette.
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The overall status was removed for Name Unavailable.
A location was updated in New Orleans.
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The overall status was removed for Name Unavailable.
A location was updated in Bangor.
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The overall status was removed for Name Unavailable.
A location was updated in Lewiston.
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The overall status was removed for Name Unavailable.
A location was updated in Cumberland.
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The overall status was removed for Name Unavailable.
A location was updated in Boston.
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The overall status was removed for Name Unavailable.
A location was updated in Burlington.
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The overall status was removed for Name Unavailable.
A location was updated in Worcester.
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The overall status was removed for Name Unavailable.
A location was updated in Ann Arbor.
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The overall status was removed for Name Unavailable.
A location was updated in Bay City.
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The overall status was removed for Name Unavailable.
A location was updated in Lansing.
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The overall status was removed for Name Unavailable.
A location was updated in Lapeer.
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The overall status was removed for Name Unavailable.
A location was updated in Saginaw.
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The overall status was removed for Name Unavailable.
A location was updated in Ypsilanti.
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The overall status was removed for Name Unavailable.
A location was updated in Minneapolis.
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The overall status was removed for Name Unavailable.
A location was updated in Tupelo.
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The overall status was removed for Name Unavailable.
A location was updated in Kansas City.
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The overall status was removed for Name Unavailable.
A location was updated in Osage Beach.
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The overall status was removed for Name Unavailable.
A location was updated in St. Louis.
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The overall status was removed for Name Unavailable.
A location was updated in Omaha.
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The overall status was removed for Name Unavailable.
A location was updated in Ridgewood.
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The overall status was removed for Name Unavailable.
A location was updated in New York.
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The overall status was removed for Name Unavailable.
A location was updated in Durham.
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The overall status was removed for Name Unavailable.
A location was updated in Hickory.
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The overall status was removed for Name Unavailable.
A location was updated in Cincinnati.
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The overall status was removed for Name Unavailable.
A location was updated in Cleveland.
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The overall status was removed for Name Unavailable.
A location was updated in Kettering.
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The overall status was removed for Name Unavailable.
A location was updated in Middletown.
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The overall status was removed for Name Unavailable.
A location was updated in Toledo.
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The overall status was removed for Name Unavailable.
A location was updated in Westlake.
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The overall status was removed for Name Unavailable.
A location was updated in Oklahoma City.
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The overall status was removed for Name Unavailable.
A location was updated in Tulsa.
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The overall status was removed for Name Unavailable.
A location was updated in Tualatin.
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The overall status was removed for Name Unavailable.
A location was updated in Abington.
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The overall status was removed for Name Unavailable.
A location was updated in Philadelphia.
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The overall status was removed for Name Unavailable.
A location was updated in Phoenixville.
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The overall status was removed for Name Unavailable.
A location was updated in Pittsburgh.
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The overall status was removed for Name Unavailable.
A location was updated in Greenville.
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The overall status was removed for Name Unavailable.
A location was updated in Rock Hill.
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The overall status was removed for Name Unavailable.
A location was updated in Cookeville.
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The overall status was removed for Name Unavailable.
A location was updated in Germantown.
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The overall status was removed for Name Unavailable.
A location was updated in Nashville.
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The overall status was removed for Name Unavailable.
A location was updated in Corpus Christi.
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The overall status was removed for Name Unavailable.
A location was updated in Houston.
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The overall status was removed for Name Unavailable.
A location was updated in Humble.
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The overall status was removed for Name Unavailable.
A location was updated in Kingwood.
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The overall status was removed for Name Unavailable.
A location was updated in Wahroonga.
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The overall status was removed for Name Unavailable.
A location was updated in Montreal.
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The overall status was removed for Name Unavailable.
A location was updated in Sherbrooke.
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The overall status was removed for Name Unavailable.
A location was updated in Aarhus.
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The overall status was removed for Name Unavailable.
A location was updated in Tubingen.
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The overall status was removed for Name Unavailable.
A location was updated in Villingen.
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The overall status was removed for Name Unavailable.
A location was updated in Birmingham.
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The overall status was removed for Name Unavailable.
11 Jan '12
Trial name was updated.
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BIOTRONIK IMPACT Study
The eligibility criteria were updated.
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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
Old
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
6 Oct '11
The eligibility criteria were updated.
New
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
Old
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