Cardiac Resynchronization Therapy Efficacy Enhancements
CRTee
1 other identifier
interventional
71
7 countries
19
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 applied is not inferior to the amount of effective CRT pacing during AF when CAFR (Conducted AF Response) is applied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable atrial-fibrillation
Started Oct 2014
Shorter than P25 for not_applicable atrial-fibrillation
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2014
CompletedFirst Posted
Study publicly available on registry
August 21, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
January 6, 2017
CompletedJanuary 6, 2017
November 1, 2016
1.3 years
August 19, 2014
November 8, 2016
November 8, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Effective CRT Pacing During AF (Non-inferiority Test)
The primary objective is to demonstrate that the percent effective CRT pacing during AF when CAFRPlus is applied is not inferior to when CAFR is applied (non-inferiority test).
Up to 4 months
Secondary Outcomes (1)
Percentage of Effective CRT Pacing During AF (Superiority Test)
Up to 4 months
Study Arms (2)
Group A: CAFR first
OTHERSubjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus.
Group B: CAFRPlus first
OTHERSubjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR.
Interventions
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.
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
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
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, 78705, 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
Related Publications (1)
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.
PMID: 29132930DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- CRTee Clinical Team
- Organization
- Medtronic Cardiac Rhythm and Heart Failure
Study Officials
- PRINCIPAL INVESTIGATOR
Suneet Mittal, MD
Valley Health System
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2014
First Posted
August 21, 2014
Study Start
October 1, 2014
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
January 6, 2017
Results First Posted
January 6, 2017
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share