Back to resultsAdaptive Cardiac Resynchronization Therapy Study (aCRT)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Adaptive CRT (aCRT)
Echo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Adaptive CRT (aCRT) arm
Echo-optimized arm
Arm Description
Intervention: Cardiac resynchronization therapy (CRT-D) with Adaptive CRT algorithm ON
Intervention: Cardiac resynchronization therapy (CRT-D) with standard biventricular pacing (Adaptive CRT algorithm OFF)
Outcomes
Primary Outcome Measures
Percentage of Patients With Improved Heart Failure Outcomes Clinical Composite Score
Patients considered worsened if they died, were hospitalized with worsening heart failure (HF), crossed over to other arm, demonstrated worsening in New York Heart Association (NYHA) functional class, or reported moderately/markedly worse on 'patient global assessment' compared to before CRT implant. Patients are improved if they are not worsened and have an improved NYHA or reported moderately/markedly improved on the 'patient global assessment' compared to before CRT implant
Global assessment question for the patient: Specifically in reference to your heart failure symptoms, how do you feel today as compared to how you felt before your CRT system was implanted? O Markedly improved O Moderately improved O Mildly improved O No change O Slightly worse O Moderately worse O Markedly worse
Correlation Between Aortic Velocity Time Integral (AoVTI) at Adaptive CRT and Echo-optimized Device Settings
Correlation between aortic velocity time integral (AoVTI) at Adaptive CRT and echo-optimized device settings. AoVTI is an echocardiographic representative of stroke volume and cardiac performance.
Percentage of Patients With a Safety Event (Inappropriate AV or VV Delay Settings Related to the aCRT Feature)
For each subject, the Adaptive CRT-determined AV and VV delay settings from randomization up to 183-days post-randomization were evaluated to identify any period of 28-days with a wide delay range (>60 ms)
Secondary Outcome Measures
Right Ventricular Pacing Percentage
The percentage of time the right ventricle is paced by the device
Change in Left Ventricular End Systolic Volume Index (LVESVi)
Change in left ventricular end systolic volume index (LVESVi).
Change in Left Ventricular Ejection Fraction (LVEF)
Change in New York Heart Association (NYHA) Classification
The New York Heart Association (NYHA) Functional Classification places patients in one of four categories based on how much they are limited during physical activity.
Class - Patient Symptoms I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).
II- Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).
III- Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.
IV- Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Change in Distance Walked During the Six Minute Hall Walk
Change in Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire (MLWHF)
The MLWHF is a 21 question survey. Scores range from 0-105, with lower scores indicating better health.
Full Information
NCT ID
NCT00980057
First Posted
September 16, 2009
Last Updated
September 18, 2018
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
1. Study Identification
Unique Protocol Identification Number
NCT00980057
Brief Title
Adaptive Cardiac Resynchronization Therapy Study
Acronym
aCRT
Official Title
Adaptive Cardiac Resynchronization Therapy Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2009 (Actual)
Primary Completion Date
August 4, 2011 (Actual)
Study Completion Date
March 8, 2012 (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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
522 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adaptive CRT (aCRT) arm
Arm Type
Experimental
Arm Description
Intervention: Cardiac resynchronization therapy (CRT-D) with Adaptive CRT algorithm ON
Arm Title
Echo-optimized arm
Arm Type
Active Comparator
Arm Description
Intervention: Cardiac resynchronization therapy (CRT-D) with standard biventricular pacing (Adaptive CRT algorithm OFF)
Intervention Type
Device
Intervention Name(s)
Adaptive CRT (aCRT)
Other Intervention Name(s)
aCRT
Intervention Description
Adaptive CRT (aCRT) is an algorithm, which provides ambulatory adjustment of pacing configuration (LV-only or BiV) and AV and VV delays based on periodic automatic evaluation of electrical conduction to optimize cardiac function
Intervention Type
Device
Intervention Name(s)
Echo
Other Intervention Name(s)
Control
Intervention Description
Standard BiV pacing with settings optimized using a standardized echocardiographic protocol
Primary Outcome Measure Information:
Title
Percentage of Patients With Improved Heart Failure Outcomes Clinical Composite Score
Description
Patients considered worsened if they died, were hospitalized with worsening heart failure (HF), crossed over to other arm, demonstrated worsening in New York Heart Association (NYHA) functional class, or reported moderately/markedly worse on 'patient global assessment' compared to before CRT implant. Patients are improved if they are not worsened and have an improved NYHA or reported moderately/markedly improved on the 'patient global assessment' compared to before CRT implant
Global assessment question for the patient: Specifically in reference to your heart failure symptoms, how do you feel today as compared to how you felt before your CRT system was implanted? O Markedly improved O Moderately improved O Mildly improved O No change O Slightly worse O Moderately worse O Markedly worse
Time Frame
randomization to six month visit
Title
Correlation Between Aortic Velocity Time Integral (AoVTI) at Adaptive CRT and Echo-optimized Device Settings
Description
Correlation between aortic velocity time integral (AoVTI) at Adaptive CRT and echo-optimized device settings. AoVTI is an echocardiographic representative of stroke volume and cardiac performance.
Time Frame
randomization visit and six month visit
Title
Percentage of Patients With a Safety Event (Inappropriate AV or VV Delay Settings Related to the aCRT Feature)
Description
For each subject, the Adaptive CRT-determined AV and VV delay settings from randomization up to 183-days post-randomization were evaluated to identify any period of 28-days with a wide delay range (>60 ms)
Time Frame
randomization to 6 months post randomization
Secondary Outcome Measure Information:
Title
Right Ventricular Pacing Percentage
Description
The percentage of time the right ventricle is paced by the device
Time Frame
implant to six months post randomization
Title
Change in Left Ventricular End Systolic Volume Index (LVESVi)
Description
Change in left ventricular end systolic volume index (LVESVi).
Time Frame
baseline to six month visit
Title
Change in Left Ventricular Ejection Fraction (LVEF)
Time Frame
baseline to six month visit
Title
Change in New York Heart Association (NYHA) Classification
Description
The New York Heart Association (NYHA) Functional Classification places patients in one of four categories based on how much they are limited during physical activity.
Class - Patient Symptoms I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).
II- Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).
III- Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.
IV- Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Time Frame
baseline to six month visit
Title
Change in Distance Walked During the Six Minute Hall Walk
Time Frame
baseline to six month visit
Title
Change in Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire (MLWHF)
Description
The MLWHF is a 21 question survey. Scores range from 0-105, with lower scores indicating better health.
Time Frame
baseline to six month visit
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adaptive CRT Trial Leader
Organizational Affiliation
Medtronic
Official's Role
Study Chair
Facility Information:
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
36264
Country
United States
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
36264
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
36264
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
36264
Country
United States
City
Glendale
State/Province
California
ZIP/Postal Code
36264
Country
United States
City
San Bernardino
State/Province
California
ZIP/Postal Code
36264
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
36264
Country
United States
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
36264
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
36264
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
36264
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
36264
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
36264
Country
United States
City
Pensacola
State/Province
Florida
ZIP/Postal Code
36264
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
36264
Country
United States
City
Barrington
State/Province
Illinois
ZIP/Postal Code
36264
Country
United States
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
36264
Country
United States
City
Davenport
State/Province
Iowa
ZIP/Postal Code
36264
Country
United States
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
36264
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
36264
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
36264
Country
United States
City
Takoma Park
State/Province
Maryland
ZIP/Postal Code
36264
Country
United States
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
36264
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
36264
Country
United States
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
36264
Country
United States
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
36264
Country
United States
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
36264
Country
United States
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
36264
Country
United States
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
36264
Country
United States
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
36264
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
36264
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
36264
Country
United States
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
36264
Country
United States
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
36264
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
36264
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
36264
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
36264
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
36264
Country
United States
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
36264
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
36264
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
36264
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
36264
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
36264
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
36264
Country
United States
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
36264
Country
United States
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
36264
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
36264
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
36264
Country
United States
City
Tyler
State/Province
Texas
ZIP/Postal Code
36264
Country
United States
City
Burlington
State/Province
Vermont
ZIP/Postal Code
36264
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
36264
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
36264
Country
United States
City
Bellingham
State/Province
Washington
ZIP/Postal Code
36264
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
36264
Country
United States
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
36264
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
36264
Country
United States
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
30991823
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.
Results Reference
derived
PubMed Identifier
28893549
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.
Results Reference
derived
PubMed Identifier
28416247
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.
Results Reference
derived
PubMed Identifier
26071616
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.
Results Reference
derived
PubMed Identifier
23851059
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.
Results Reference
derived
PubMed Identifier
22607850
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.
Results Reference
derived
Learn more about this trial
Adaptive Cardiac Resynchronization Therapy Study
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