Back to resultsCardiac Resynchronization Therapy Efficacy Enhancements (CRTee)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Conducted AF Response (CAFR)
Conducted AF Response Plus (CAFRPlus)
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
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 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 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.
Sites / Locations
- Cardiac Arrythmia Services
- Iowa Heart Center
- North Memorial Heart and Vascular
- CentraCare
- North Carolina Heart and Vascular
- Mount Carmel
- Oklahoma Heart
- Berks Cardiology
- Texas Cardiac Arrhythmia Services
- Kootenai Heart Clinics
- Magyar Honvédség Honvédkorház
- Policlinico Universitario Agostino Gemelli
- Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini
- Azienda Ospedaliera Cardinale Panico
- Prince Sultan Cardiac Center
- Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.
- Mediclinic Panorama
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- he Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group A: CAFR first
Group B: CAFRPlus first
Arm Description
Subjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus.
Subjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Percentage of Effective CRT Pacing During AF (Superiority Test)
The secondary objective is to demonstrate that the percent effective CRT pacing during AF when CAFRPlus is applied is greater than when CAFR is applied (superiority test).
Full Information
NCT ID
NCT02222818
First Posted
August 19, 2014
Last Updated
November 8, 2016
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
1. Study Identification
Unique Protocol Identification Number
NCT02222818
Brief Title
Cardiac Resynchronization Therapy Efficacy Enhancements
Acronym
CRTee
Official Title
Cardiac Resynchronization Therapy Efficacy Enhancements
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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 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.
The study will be conducted at up to 30 centers located in the United States, Europe and Middle East and Africa (MEA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A: CAFR first
Arm Type
Other
Arm Description
Subjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus.
Arm Title
Group B: CAFRPlus first
Arm Type
Other
Arm Description
Subjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR.
Intervention Type
Device
Intervention Name(s)
Conducted AF Response (CAFR)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Conducted AF Response Plus (CAFRPlus)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Effective CRT Pacing During AF (Non-inferiority Test)
Description
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).
Time Frame
Up to 4 months
Secondary Outcome Measure Information:
Title
Percentage of Effective CRT Pacing During AF (Superiority Test)
Description
The secondary objective is to demonstrate that the percent effective CRT pacing during AF when CAFRPlus is applied is greater than when CAFR is applied (superiority test).
Time Frame
Up to 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suneet Mittal, MD
Organizational Affiliation
Valley Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiac Arrythmia Services
City
Boca Raton
State/Province
Florida
Country
United States
Facility Name
Iowa Heart Center
City
West Des Moines
State/Province
Iowa
Country
United States
Facility Name
North Memorial Heart and Vascular
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
CentraCare
City
St. Cloud
State/Province
Minnesota
Country
United States
Facility Name
North Carolina Heart and Vascular
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Mount Carmel
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Oklahoma Heart
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Berks Cardiology
City
Reading
State/Province
Pennsylvania
Country
United States
Facility Name
Texas Cardiac Arrhythmia Services
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Kootenai Heart Clinics
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Magyar Honvédség Honvédkorház
City
Budapest
Country
Hungary
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
Country
Italy
Facility Name
Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini
City
Seriate
Country
Italy
Facility Name
Azienda Ospedaliera Cardinale Panico
City
Tricase
Country
Italy
Facility Name
Prince Sultan Cardiac Center
City
Riyadh
Country
Saudi Arabia
Facility Name
Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.
City
Kosice
Country
Slovakia
Facility Name
Mediclinic Panorama
City
Cape Town
Country
South Africa
Facility Name
Liverpool Heart and Chest Hospital NHS Foundation Trust
City
Liverpool
Country
United Kingdom
Facility Name
he Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
City
Newcastle Upon Tyne
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29132930
Citation
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.
Results Reference
derived
Learn more about this trial
Cardiac Resynchronization Therapy Efficacy Enhancements
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