Cardiac Resynchronization Therapy Efficacy Enhancements
NCT ID: NCT02222818
Last Updated: 2017-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
71 participants
INTERVENTIONAL
2014-10-31
2016-01-31
Brief Summary
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Detailed Description
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The study will be conducted at up to 30 centers located in the United States, Europe and Middle East and Africa (MEA).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group A: CAFR first
Subjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus.
Conducted AF Response (CAFR)
The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.
Conducted AF Response Plus (CAFRPlus)
The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing.
Group B: CAFRPlus first
Subjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR.
Conducted AF Response (CAFR)
The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.
Conducted AF Response Plus (CAFRPlus)
The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing.
Interventions
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Conducted AF Response (CAFR)
The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.
Conducted AF Response Plus (CAFRPlus)
The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing.
Eligibility Criteria
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Inclusion Criteria
* Subject is at least 18 years of age (or older, if required by local law).
* Subject is expected to remain available after enrollment to complete follow-up visits in both arms of the study
* Subject has had a Medtronic Viva or Brava CRT-D device implanted at least 30 days prior to enrollment.
* Subject has history of AF burden, of at least 6 days of at least 4 hours of AF over any 4 week period within the last 90 days as documented in device diagnostic data OR if subject has no atrial lead (therefore no device diagnostic data) but clinical evidence of high AF burden.
* Subject has demonstrated history of being able to complete Left Ventricular Capture Management (LVCM) documented in device data.
* Subject has a documented % V pacing during AF of less than or equal to 97% within 90 days prior to enrollment or within 10 days after enrollment.
Exclusion Criteria
* Subject has complete or 3rd degree AV block.
* Subject has had an MI within 30 days.
* Subject has medical conditions that limit study participation (per physician discretion).
* Subject is enrolled in one or more concurrent studies that could confound the study results as determined by Medtronic.
* Subject has a limited life expectancy for non-cardiac causes that would not allow completion of the study.
* Subject is pregnant (in the US, all women of child-bearing potential must undergo a pregnancy test within seven days prior to CRTee download).
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Suneet Mittal, MD
Role: PRINCIPAL_INVESTIGATOR
Valley Health System
Locations
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Cardiac Arrythmia Services
Boca Raton, Florida, United States
Iowa Heart Center
West Des Moines, Iowa, United States
North Memorial Heart and Vascular
Minneapolis, Minnesota, United States
CentraCare
Saint Cloud, Minnesota, United States
North Carolina Heart and Vascular
Raleigh, North Carolina, United States
Mount Carmel
Columbus, Ohio, United States
Oklahoma Heart
Oklahoma City, Oklahoma, United States
Berks Cardiology
Reading, Pennsylvania, United States
Texas Cardiac Arrhythmia Services
Austin, Texas, United States
Kootenai Heart Clinics
Spokane, Washington, United States
Magyar Honvédség Honvédkorház
Budapest, , Hungary
Policlinico Universitario Agostino Gemelli
Roma, , Italy
Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini
Seriate, , Italy
Azienda Ospedaliera Cardinale Panico
Tricase, , Italy
Prince Sultan Cardiac Center
Riyadh, , Saudi Arabia
Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.
Košice, , Slovakia
Mediclinic Panorama
Cape Town, , South Africa
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, , United Kingdom
he Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Plummer CJ, Frank CM, Bari Z, Al Hebaishi YS, Klepfer RN, Stadler RW, Ghosh S, Liu S, Mittal S. A novel algorithm increases the delivery of effective cardiac resynchronization therapy during atrial fibrillation: The CRTee randomized crossover trial. Heart Rhythm. 2018 Mar;15(3):369-375. doi: 10.1016/j.hrthm.2017.10.026. Epub 2017 Nov 11.
Other Identifiers
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CRTee
Identifier Type: -
Identifier Source: org_study_id
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