Clinical trial NCT00980057: Adaptive Cardiac Resynchronization Therapy Study
Official title: Adaptive Cardiac Resynchronization Therapy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2009-09-18
Enrollment: 522
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the AdaptivCRT algorithm is at least as good as manual echo based optimization in regard to patient outcomes and cardiac performance

Detailed description: The trial has 3 primary end points:

* to demonstrate that over 6-month follow-up, the proportion of the patients improved in the aCRT arm is at least as high as in the Echo arm
* to demonstrate that cardiac function is similar when using aCRT versus echo-optimized settings
* to demonstrate that aCRT does not result in inappropriate AV or VV delay settings

Eligibility criteria: Inclusion Criteria:

* Subject is willing to sign and date the study Informed Consent form
* Subject is at least 18 years of age (or older, if required by local law)
* Subject is expected to remain available for at least six months of follow-up visits
* Subject is indicated for a study device that will be implanted within 30 days after signing the Informed Consent form
* Subject has an intrinsic QRS duration greater than or equal to 120 milliseconds (documented within 30 days prior to enrollment)
* Subject has a left ventricular ejection fraction less than or equal to 35 percent (method per physician discretion) (documented within 180 days prior to enrollment)
* Subject is diagnosed with New York Heart Association (NYHA) class III or IV (within 30 days prior to enrollment) despite optimal medical therapy which is defined as: ACE-inhibitor (Angiotensin-Converting Enzyme) or Angiotensin II Receptor Blocker (ARB), if tolerated, for at least one month prior to implant, AND beta-blocker for at least three months preceding implant, if tolerated, and stable for one month, OR subject has an urgent medical need for an implantable cardioverter defibrillator (ICD) that precludes waiting the one or three months for the medication requirements for ACE inhibitor, ARB or beta-blocker

Exclusion Criteria:

* Subject has chronic (permanent) atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted
* Subject has existing CRT system
* Subject has non-intact or unstable leads
* Subject has medical conditions that would limit study participation (per physician discretion)
* Subject is enrolled in one or more concurrent studies that would confound the study results of this study as determined by Medtronic
* Subject has unstable angina, or experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) (documented within 30 days prior to enrollment)
* Subject has a mechanical right heart valve or is scheduled to undergo valve repair or valve replacement during the course of the study
* Subject is post-heart transplant (subjects on the heart transplant list for the first time are not excluded)
* Subject has a limited life expectancy that would not allow completion of the 6 month visit
* Subject is pregnant (In the United States, all women of child-bearing potential must undergo a pregnancy test within seven days prior to aCRT download into device)
* Subject meets the exclusion criteria required by local law

Primary outcomes:
measure: Percentage of Patients With Improved Heart Failure Outcomes Clinical Composite Score
timeFrame: randomization to six month visit
measure: Correlation Between Aortic Velocity Time Integral (AoVTI) at Adaptive CRT and Echo-optimized Device Settings
timeFrame: randomization visit and six month visit
measure: Percentage of Patients With a Safety Event (Inappropriate AV or VV Delay Settings Related to the aCRT Feature)
timeFrame: randomization to 6 months post randomization
Secondary outcomes:
measure: Right Ventricular Pacing Percentage
timeFrame: implant to six months post randomization
measure: Change in Left Ventricular End Systolic Volume Index (LVESVi)
timeFrame: baseline to six month visit
measure: Change in Left Ventricular Ejection Fraction (LVEF)
timeFrame: baseline to six month visit
measure: Change in New York Heart Association (NYHA) Classification
timeFrame: baseline to six month visit
measure: Change in Distance Walked During the Six Minute Hall Walk
timeFrame: baseline to six month visit
measure: Change in Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire (MLWHF)
timeFrame: baseline to six month visit
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Anchorage
country: United States
state: Alaska
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Glendale
country: United States
state: California
city: San Bernardino
country: United States
state: California
city: San Diego
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Clearwater
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Barrington
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Davenport
country: United States
state: Iowa
city: Des Moines
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Takoma Park
country: United States
state: Maryland
city: Burlington
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Saginaw
country: United States
state: Michigan
city: Saint Cloud
country: United States
state: Minnesota
city: Saint Louis Park
country: United States
state: Minnesota
city: Saint Paul
country: United States
state: Minnesota
city: Tupelo
country: United States
state: Mississippi
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Morristown
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Buffalo
country: United States
state: New York
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Charleston
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Bellingham
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Adelaide
country: Australia
city: Camperdown
country: Australia
city: Chermside
country: Australia
city: Darlinghurst
country: Australia
city: Perth
country: Australia
city: Spring Hill
country: Australia
city: Linz
country: Austria
city: Genk
country: Belgium
city: Leuven
country: Belgium
city: Yvoir
country: Belgium
city: Calgary
country: Canada
city: London
country: Canada
city: Montreal
country: Canada
city: Newmarket
country: Canada
city: Ottawa
country: Canada
city: Victoria
country: Canada
city: Aalborg
country: Denmark
city: København
country: Denmark
city: Odense
country: Denmark
city: Århus
country: Denmark
city: Bochum
country: Germany
city: Hamburg
country: Germany
city: Ludenscheid
country: Germany
city: Reinbek
country: Germany
city: Trier
country: Germany
city: Athens
country: Greece
city: Hong Kong
country: Hong Kong
city: Budapest
country: Hungary
city: Milano
country: Italy
city: Pavia
country: Italy
city: Pedara
country: Italy
city: Rozzano
country: Italy
city: Osaka
country: Japan
city: Tokyo
country: Japan
city: Tsukuba city
country: Japan
city: Nijmegen
country: Netherlands
city: Rotterdam
country: Netherlands
city: Bergen
country: Norway
city: Oslo
country: Norway
city: Tyumen
country: Russian Federation
city: Riyadh
country: Saudi Arabia
city: Belgrade
country: Serbia
city: Nis
country: Serbia
city: Sremska Kamenica
country: Serbia
city: Albacete
country: Spain
city: Madrid
country: Spain
city: Majadahonda
country: Spain
city: Vitoria-Gasteiz
country: Spain
city: Lund
country: Sweden
city: Stockholm
country: Sweden
Study officials:
affiliation: Medtronic
name: Adaptive CRT Trial Leader
role: STUDY_CHAIR
References:
citation: Gasparini M, Birnie D, Lemke B, Aonuma K, Lee KL, Gorcsan J 3rd, Landolina M, Klepfer R, Meloni S, Cicconelli M, Grammatico A, Martin DO. Adaptive Cardiac Resynchronization Therapy Reduces Atrial Fibrillation Incidence in Heart Failure Patients With Prolonged AV Conduction: The Adaptive CRT Randomized Trial. Circ Arrhythm Electrophysiol. 2019 May;12(5):e007260. doi: 10.1161/CIRCEP.119.007260. No abstract available.
citation: Birnie D, Hudnall H, Lemke B, Aonuma K, Lee KL, Gasparini M, Gorcsan J 3rd, Cerkvenik J, Martin DO. Continuous optimization of cardiac resynchronization therapy reduces atrial fibrillation in heart failure patients: Results of the Adaptive Cardiac Resynchronization Therapy Trial. Heart Rhythm. 2017 Dec;14(12):1820-1825. doi: 10.1016/j.hrthm.2017.08.017. Epub 2017 Sep 9.
citation: Yamasaki H, Lustgarten D, Cerkvenik J, Birnie D, Gasparini M, Lee KL, Sekiguchi Y, Varma N, Lemke B, Starling RC, Aonuma K. Adaptive CRT in patients with normal AV conduction and left bundle branch block: Does QRS duration matter? Int J Cardiol. 2017 Aug 1;240:297-301. doi: 10.1016/j.ijcard.2017.04.036. Epub 2017 Apr 12.
citation: Starling RC, Krum H, Bril S, Tsintzos SI, Rogers T, Hudnall JH, Martin DO. Impact of a Novel Adaptive Optimization Algorithm on 30-Day Readmissions: Evidence From the Adaptive CRT Trial. JACC Heart Fail. 2015 Jul;3(7):565-572. doi: 10.1016/j.jchf.2015.03.001. Epub 2015 Jun 10.
citation: Birnie D, Lemke B, Aonuma K, Krum H, Lee KL, Gasparini M, Starling RC, Milasinovic G, Gorcsan J 3rd, Houmsse M, Abeyratne A, Sambelashvili A, Martin DO. Clinical outcomes with synchronized left ventricular pacing: analysis of the adaptive CRT trial. Heart Rhythm. 2013 Sep;10(9):1368-74. doi: 10.1016/j.hrthm.2013.07.007. Epub 2013 Jul 11.
citation: Krum H, Lemke B, Birnie D, Lee KL, Aonuma K, Starling RC, Gasparini M, Gorcsan J, Rogers T, Sambelashvili A, Kalmes A, Martin D. A novel algorithm for individualized cardiac resynchronization therapy: rationale and design of the adaptive cardiac resynchronization therapy trial. Am Heart J. 2012 May;163(5):747-752.e1. doi: 10.1016/j.ahj.2012.02.007.