Atrial FibrillationCRTeeNCT02222818
Cardiac Resynchronization Therapy Efficacy Enhancements
A study testing Conducted AF Response (CAFR) and Conducted AF Response Plus (CAFRPlus) in people with Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 19 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Conducted AF Response (CAFR) and Conducted AF Response Plus (CAFRPlus)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 19 sitesin 7 countries
- Study dates
- Oct 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 7 countries.
19 sites in 7 countries
United States10 sites
Texas Cardiac Arrhythmia Services
Austin, Texas, 78705
Cardiac Arrythmia Services
Boca Raton, Florida
Mount Carmel
Columbus, Ohio
North Memorial Heart and Vascular
Minneapolis, Minnesota
Oklahoma Heart
Oklahoma City, Oklahoma
North Carolina Heart and Vascular
Raleigh, North Carolina
Berks Cardiology
Reading, Pennsylvania
CentraCare
Saint Cloud, Minnesota
Kootenai Heart Clinics
Spokane, Washington
Iowa Heart Center
West Des Moines, Iowa
Italy3 sites
Policlinico Universitario Agostino Gemelli
Roma
Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini
Seriate
Azienda Ospedaliera Cardinale Panico
Tricase
United Kingdom2 sites
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool
he Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle upon Tyne
Slovakia1 site
Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.
Košice
About this study
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.
Read the 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).
- Conditions
- Atrial Fibrillation
- Being tested
- Conducted AF Response (CAFR), Conducted AF Response Plus (CAFRPlus)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conducted AF Response (CAFR)Device
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)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: CAFR first | Other | Subjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus. Receives: Device: Conducted AF Response (CAFR); Device: Conducted AF Response Plus (CAFRPlus) |
| Group B: CAFRPlus first | Other | Subjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR. Receives: Device: Conducted AF Response (CAFR); Device: Conducted AF Response Plus (CAFRPlus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 4 months
Secondary outcomes (1)
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).
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suneet Mittal, MD, Principal investigator, Valley Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222818
- Sponsor's protocol ID
- CRTee
- Acronym
- CRTee
- Status last verified
- Nov 2016
- First submitted
- 19 Aug 2014
- Last updated
- 6 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29132930
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Resynchronization Therapy Efficacy Enhancements
- ClinicalTrials.gov ID
- NCT02222818
- Acronym / sponsor ID
- CRTee / CRTee
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 21 Aug 2014 (estimated)
- Results
- Posted 6 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: CAFR first | Other | Device: Conducted AF Response (CAFR), Device: Conducted AF Response Plus (CAFRPlus)Subjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus. |
| Group B: CAFRPlus first | Other | Device: Conducted AF Response (CAFR), Device: Conducted AF Response Plus (CAFRPlus)Subjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Group A: CAFR first, Group B: CAFRPlus first |
| 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. | Device | Group A: CAFR first, Group B: CAFRPlus first |
Primary outcome
Percentage of Effective CRT Pacing During AF (Non-inferiority Test)
Time frame: Up to 4 months
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).
1 secondary outcome
Percentage of Effective CRT Pacing During AF (Superiority Test)
Time frame: Up to 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29132930Plummer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suneet Mittal, MD principal investigator
Valley Health System
19 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conducted AF Response (CAFR) and Conducted AF Response Plus (CAFRPlus) in people with Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 19 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Italy, United Kingdom, Hungary, Saudi Arabia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Effective CRT Pacing During AF (Non-inferiority Test) (time frame: Up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02222818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2017.