Status:
COMPLETED
Cardiac Resynchronization Therapy Efficacy Enhancements
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to demonstrate that the amount of effective CRT (Cardiac Resynchronization Therapy) pacing during AF (atrial fibrillation) when CAFRPlus (Conducted AF Response Plus) is ap...
Detailed Description
The CRTee study is an IDE, prospective, multi-center, randomized, controlled, crossover clinical study, conducted worldwide and designed to demonstrate that the amount of effective CRT pacing during A...
Eligibility Criteria
Inclusion
- 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 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
- 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 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).
- Subject meets the exclusion criteria required by local law.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT02222818
Start Date
October 1 2014
End Date
January 1 2016
Last Update
January 6 2017
Active Locations (19)
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1
Cardiac Arrythmia Services
Boca Raton, Florida, United States
2
Iowa Heart Center
West Des Moines, Iowa, United States
3
North Memorial Heart and Vascular
Minneapolis, Minnesota, United States
4
CentraCare
Saint Cloud, Minnesota, United States