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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02205359
Registration number
NCT02205359
Ethics application status
Date submitted
18/07/2014
Date registered
31/07/2014
Date last updated
29/11/2023
Titles & IDs
Public title
AdaptResponse Clinical Trial
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Scientific title
AdaptResponse Clinical Trial
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Secondary ID [1]
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AdaptResponse
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure With Left Bundle Branch Block
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - aCRT ON
Treatment: Devices - aCRT OFF
Experimental: aCRT ON - The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise
Active comparator: aCRT OFF - Standard CRT
Treatment: Devices: aCRT ON
CRT device with AdaptivCRT enabled (AdaptivBiV and LV)
Treatment: Devices: aCRT OFF
CRT device with AdaptivCRT disabled
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Combined Endpoint of All-cause Mortality and Intervention for Heart Failure Decompensation
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Assessment method [1]
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The first occurrence of death or intervention for heart failure decompensation (defined as an event requiring invasive intervention or inpatient hospitalization).
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Timepoint [1]
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from subject randomization until the first occurrence of death or intervention for heart failure decompensation, median follow-up 4.9 years (max. follow-up 8.1 years)
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Secondary outcome [1]
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All-cause Mortality
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Assessment method [1]
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All-cause mortality in the aCRT ON group vs the aCRT OFF group
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Timepoint [1]
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from subject randomization until the occurrence of death, median follow-up 4.9 years (max. follow-up 8.1 years)
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Secondary outcome [2]
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Percent of Patients With Interventions for Heart Failure Decompensation
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Assessment method [2]
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First occurence of intervention for heart failure decompensation is defined as an event requiring invasive intervention or inpatient hospitalization.
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Timepoint [2]
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from subject randomization until the first occurrence of intervention for heart failure decompensation, median follow-up 4.9 years (max. follow-up 8.1 years)
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Secondary outcome [3]
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Clinical Composite Score
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Assessment method [3]
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The Clinical Composite Score (CCS) classifies patients according their clinical status at 6 months post randomization into categories Improved, Unchanged, and Worsened. A patient is classified Worsened in case of death, hospitalization for worsening heart failure, worsened NYHA class (using last observation carried forward), or worsened status on the Global Assessment Score. Also patients that exit the study or cross over because of worsening heart failure are classified Worsened. A patient is classified Improved when not Worsened and there is an improvement in NYHA class or Global Assessment Score. Patients that are not Worsened or Improved are Unchanged.
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Timepoint [3]
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CCS at 6 month post randomization
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Secondary outcome [4]
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Atrial Fibrillation
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Assessment method [4]
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Occurrence of atrial fibrillation lasting \>6 hours in one day
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Timepoint [4]
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from subject randomization until the first occurrence of atrial fibrillation lasting >6 hours in one day, median follow-up 4.9 years (max. follow-up 8.1 years)
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Secondary outcome [5]
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Change in Quality of Life Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
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Assessment method [5]
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The overall summary score of the Kansas City Cardiomyopathy Questionnaire will be analyzed. The KCCQ measures Quality of Life on a 0-100 scale with higher scores indicating better QoL
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Timepoint [5]
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from baseline to 24M follow up
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Secondary outcome [6]
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Change in Quality of Life Measured by the EQ-5D
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Assessment method [6]
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The EQ-5D descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN /DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has three levels: no problems, some problems, extreme problems (labelled 1-3). We calculated the EQ-5D summary index by applying a specific formula providing a valuation to the health states (Shaw et al. Medical Care 2005). For the summary index, value 0 represents health that is valued as equal to death and value 1 represents best possible health.
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Timepoint [6]
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from baseline to 24M follow up
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Secondary outcome [7]
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All-cause Re-admissions Within 30 Days After a Heart Failure Admission Per 100 Patient Years
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Assessment method [7]
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All-cause hospital re-admissions within 30 days after discharge from a heart failure admission are reported as number of cases per 100 patient years
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Timepoint [7]
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from subject randomization until study exit, median follow-up 4.9 years (max. follow-up 8.1 years)
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Eligibility
Key inclusion criteria
* Subject is willing to sign and date the study Patient Informed Consent Form.
* Subject is indicated for a CRT device according to local guidelines.
* Sinus Rhythm at time of enrollment
* Complete Left Bundle Branch Block (LBBB) as documented on an ECG (within 30 days prior to enrollment). Strauss Criteria used for LBBB.
* Intrinsic, normal AV conduction as documented on an ECG by a PR interval less than or equal to 200ms (within 30 days prior to enrollment).
* Left ventricular ejection fraction less than or equal to 35% (documented within 180 days prior to enrollment).
* NYHA class II, III or IV (documented within 30 days prior to enrollment) despite optimal medical therapy. Optimal medical therapy is defined as maximal tolerated dose of Beta-blockers and a therapeutic dose of ACE-I, ARB or Aldosterone Antagonist.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Subject is less than 18 years of age (or has not reached minimum age per local law).
* Subject is not expected to remain available for at least 2 years of follow-up visits.
* Subject has permanent atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted
* Subject is, or previously has been, receiving cardiac resynchronization therapy.
* Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
* Subject has unstable angina, or experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within 30 days prior to enrollment.
* Subject has a mechanical tricuspid 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 due to non-cardiac causes that would not allow completion of the study.
* Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to device implant).
* Subject meets any exclusion criteria required by local law.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/11/2022
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Sample size
Target
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Accrual to date
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Final
3797
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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John Hunter Hospital - New Lambton
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Austin Hospital - Heidelberg
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [4]
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Saint Vincent's Hospital (Sydney) - Sydney
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- New Lambton
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- Heidelberg
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- Murdoch
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- Sydney
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Recruitment outside Australia
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Manchester
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Funding & Sponsors
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Commercial sector/industry
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Name
Medtronic Cardiac Rhythm and Heart Failure
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Summary
Brief summary
The purpose of this clinical study is to test the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) conduction and left bundle branch block (LBBB).
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Trial website
https://clinicaltrials.gov/study/NCT02205359
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Trial related presentations / publications
Wilkoff BL, Birnie D, Gold MR, Hersi AS, Jacobs S, Gerritse B, Kusano K, Leclercq C, Mullens W, Filippatos G. Differences in clinical characteristics and reported quality of life of men and women undergoing cardiac resynchronization therapy. ESC Heart Fail. 2020 Oct;7(5):2972-2982. doi: 10.1002/ehf2.12914. Epub 2020 Aug 13. Filippatos G, Birnie D, Gold MR, Gerritse B, Hersi A, Jacobs S, Kusano K, Leclercq C, Mullens W, Wilkoff BL; AdaptResponse Investigators. Rationale and design of the AdaptResponse trial: a prospective randomized study of cardiac resynchronization therapy with preferential adaptive left ventricular-only pacing. Eur J Heart Fail. 2017 Jul;19(7):950-957. doi: 10.1002/ejhf.895.
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Public notes
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Contacts
Principal investigator
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Bruce Wilkoff, MD
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The Cleveland Clinic
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What supporting documents are/will be available?
No Supporting Document Provided
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Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/59/NCT02205359/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/59/NCT02205359/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02205359
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