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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00980057




Registration number
NCT00980057
Ethics application status
Date submitted
16/09/2009
Date registered
18/09/2009
Date last updated
16/10/2018

Titles & IDs
Public title
Adaptive Cardiac Resynchronization Therapy Study
Scientific title
Adaptive Cardiac Resynchronization Therapy Study
Secondary ID [1] 0 0
Adaptive CRT
Universal Trial Number (UTN)
Trial acronym
aCRT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Adaptive CRT (aCRT)
Treatment: Devices - Echo

Experimental: Adaptive CRT (aCRT) arm - Intervention: Cardiac resynchronization therapy (CRT-D) with Adaptive CRT algorithm ON

Active Comparator: Echo-optimized arm - Intervention: Cardiac resynchronization therapy (CRT-D) with standard biventricular pacing (Adaptive CRT algorithm OFF)


Treatment: Devices: Adaptive CRT (aCRT)
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

Treatment: Devices: Echo
Standard BiV pacing with settings optimized using a standardized echocardiographic protocol

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
randomization to six month visit
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
randomization visit and six month visit
Primary outcome [3] 0 0
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)
Timepoint [3] 0 0
randomization to 6 months post randomization
Secondary outcome [1] 0 0
Right Ventricular Pacing Percentage - The percentage of time the right ventricle is paced by the device
Timepoint [1] 0 0
implant to six months post randomization
Secondary outcome [2] 0 0
Change in Left Ventricular End Systolic Volume Index (LVESVi) - Change in left ventricular end systolic volume index (LVESVi).
Timepoint [2] 0 0
baseline to six month visit
Secondary outcome [3] 0 0
Change in Left Ventricular Ejection Fraction (LVEF)
Timepoint [3] 0 0
baseline to six month visit
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
baseline to six month visit
Secondary outcome [5] 0 0
Change in Distance Walked During the Six Minute Hall Walk
Timepoint [5] 0 0
baseline to six month visit
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
baseline to six month visit

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- Chermside
Recruitment hospital [4] 0 0
- Darlinghurst
Recruitment hospital [5] 0 0
- Perth
Recruitment hospital [6] 0 0
- Spring Hill
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Chermside
Recruitment postcode(s) [4] 0 0
- Darlinghurst
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment postcode(s) [6] 0 0
- Spring Hill
Recruitment outside Australia
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United States of America
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Alabama
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Alaska
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Arizona
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Indiana
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Iowa
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Kansas
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Kentucky
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Massachusetts
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Michigan
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Austria
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Aalborg
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Odense
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Trier
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Greece
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Athens
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Hong Kong
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Hong Kong
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Hungary
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Budapest
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Italy
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Milano
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Italy
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Pavia
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Italy
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Pedara
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Italy
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Rozzano
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Japan
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Osaka
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Japan
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Tokyo
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Japan
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Tsukuba city
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Netherlands
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Nijmegen
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Netherlands
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Rotterdam
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Norway
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Bergen
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Norway
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Oslo
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Russian Federation
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Tyumen
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Saudi Arabia
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Riyadh
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Serbia
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Belgrade
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Serbia
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Nis
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Serbia
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Sremska Kamenica
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Spain
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Albacete
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Madrid
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Vitoria-Gasteiz
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Lund
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Sweden
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Stockholm

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT00980057
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Adaptive CRT Trial Leader
Address 0 0
Medtronic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications