Phase
Condition
Dysrhythmia
Chest Pain
Atrial Fibrillation
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is willing to sign and date the study patient Informed Consent form.
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 visitsin both arms of the study
Subject has had a Medtronic Viva or Brava CRT-D device implanted at least 30 daysprior to enrollment.
Subject has history of AF burden, of at least 6 days of at least 4 hours of AF overany 4 week period within the last 90 days as documented in device diagnostic data ORif subject has no atrial lead (therefore no device diagnostic data) but clinicalevidence of high AF burden.
Subject has demonstrated history of being able to complete Left Ventricular CaptureManagement (LVCM) documented in device data.
Subject has a documented % V pacing during AF of less than or equal to 97% within 90days prior to enrollment or within 10 days after enrollment.
Exclusion
Exclusion Criteria:
Subject has undergone AV node ablation for treatment of AF.
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 physiciandiscretion).
Subject is enrolled in one or more concurrent studies that could confound the studyresults as determined by Medtronic.
Subject has a limited life expectancy for non-cardiac causes that would not allowcompletion of the study.
Subject is pregnant (in the US, all women of child-bearing potential must undergo apregnancy test within seven days prior to CRTee download).
Subject meets the exclusion criteria required by local law.
Study Design
Study Description
Connect with a study center
Magyar Honvédség Honvédkorház
Budapest,
HungarySite Not Available
Policlinico Universitario Agostino Gemelli
Roma,
ItalySite Not Available
Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini
Seriate,
ItalySite Not Available
Azienda Ospedaliera Cardinale Panico
Tricase,
ItalySite Not Available
Prince Sultan Cardiac Center
Riyadh,
Saudi ArabiaSite Not Available
Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.
Kosice,
SlovakiaSite Not Available
Mediclinic Panorama
Cape Town,
South AfricaSite Not Available
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool,
United KingdomSite Not Available
he Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle Upon Tyne,
United KingdomSite Not Available
Cardiac Arrythmia Services
Boca Raton, Florida
United StatesSite Not Available
Iowa Heart Center
West Des Moines, Iowa
United StatesSite Not Available
North Memorial Heart and Vascular
Minneapolis, Minnesota
United StatesSite Not Available
Medtronic, Inc
Mounds View, Minnesota 55118
United StatesSite Not Available
CentraCare
St. Cloud, Minnesota
United StatesSite Not Available
North Carolina Heart and Vascular
Raleigh, North Carolina
United StatesSite Not Available
Mount Carmel
Columbus, Ohio
United StatesSite Not Available
Oklahoma Heart
Oklahoma City, Oklahoma
United StatesSite Not Available
Berks Cardiology
Reading, Pennsylvania
United StatesSite Not Available
Texas Cardiac Arrhythmia Services
Austin, Texas 78705
United StatesSite Not Available
Kootenai Heart Clinics
Spokane, Washington
United StatesSite Not Available

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