Clinical trial NCT02222818: Cardiac Resynchronization Therapy Efficacy Enhancements
Official title: Cardiac Resynchronization Therapy Efficacy Enhancements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2014-08-21
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Percentage of Effective CRT Pacing During AF (Non-inferiority Test)
timeFrame: Up to 4 months
Secondary outcomes:
measure: Percentage of Effective CRT Pacing During AF (Superiority Test)
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Cardiac Arrythmia Services
state: Florida
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Minneapolis
country: United States
facility: North Memorial Heart and Vascular
state: Minnesota
city: St. Cloud
country: United States
facility: CentraCare
state: Minnesota
city: Raleigh
country: United States
facility: North Carolina Heart and Vascular
state: North Carolina
city: Columbus
country: United States
facility: Mount Carmel
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart
state: Oklahoma
city: Reading
country: United States
facility: Berks Cardiology
state: Pennsylvania
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Services
state: Texas
city: Spokane
country: United States
facility: Kootenai Heart Clinics
state: Washington
city: Budapest
country: Hungary
facility: Magyar Honvédség Honvédkorház
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Seriate
country: Italy
facility: Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini
city: Tricase
country: Italy
facility: Azienda Ospedaliera Cardinale Panico
city: Riyadh
country: Saudi Arabia
facility: Prince Sultan Cardiac Center
city: Kosice
country: Slovakia
facility: Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.
city: Cape Town
country: South Africa
facility: Mediclinic Panorama
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital NHS Foundation Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: he Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Study officials:
affiliation: Valley Health System
name: Suneet Mittal, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.