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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01522898
Registration number
NCT01522898
Ethics application status
Date submitted
25/01/2012
Date registered
1/02/2012
Date last updated
13/11/2020
Titles & IDs
Public title
Cardiac Resynchronisation Therapy and AV Nodal Ablation Trial in Atrial Fibrillation Patients (CAAN-AF)
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Scientific title
Cardiac Resynchronisation Therapy and AV Nodal Ablation Trial in Atrial Fibrillation
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Secondary ID [1]
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RAH-HREC-Protocol-#111234
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Universal Trial Number (UTN)
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Trial acronym
CAAN-AF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
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Atrial Fibrillation
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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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: Surgery - AV nodal ablation
Treatment: Drugs - Medical Ventricular Rate Control
Active comparator: Medical Rate Control - Medical Rate Control aimed at ventricular rate target of 90 beats per minute. Specific medical therapy to be determined for each patient by individual clinician.
Experimental: AV nodal ablation - AV node ablation performed by percutaneous catheter ablation, with endpoint of complete heart block.
Treatment: Surgery: AV nodal ablation
Percutaneous catheter ablation of the AV node.
Treatment: Drugs: Medical Ventricular Rate Control
Ventricular Rate Control with target ventricular rate of 90 beats per minute.
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Intervention code [1]
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Treatment: Surgery
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Intervention code [2]
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Treatment: Drugs
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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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All-cause mortality and non-fatal heart failure events
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Assessment method [1]
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This is a composite of all-cause mortality and non-fatal heart failure events. All-cause mortality will be determined by a designated clinical events committee.
Heart Failure events will be documented by clinical data from the hospital In CAAN-AF, a subject will be described as having a "Heart Failure Event" when the subject has symptoms and/or signs consistent with congestive heart failure and:
* responsive to parenteral diuretic or inotropic support as an outpatient
* responsive to oral or parenteral diuretic or inotropic support during an inpatient stay
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Timepoint [1]
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Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)
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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 will be determined after adjudication committee review of clinical records, and death certificate data.
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Timepoint [1]
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Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)f recruitment
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Secondary outcome [2]
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Cardiovascular mortality
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Assessment method [2]
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Cardiovascular deaths will be classified in terms of suddenness and arrhythmic mechanism according to the Hinkle-Thaler criteria.
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Timepoint [2]
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Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)
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Secondary outcome [3]
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Non-Fatal Heart Failure Events
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Assessment method [3]
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Heart Failure events will be documented by clinical data from the hospital In CAAN-AF, a subject will be described as having a "Heart Failure Event" when the subject has symptoms and/or signs consistent with congestive heart failure and:
* responsive to parenteral diuretic or inotropic support as an outpatient
* responsive to oral or parenteral diuretic or inotropic support during an inpatient stay
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Timepoint [3]
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Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)
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Secondary outcome [4]
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6-minute walking distance
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Assessment method [4]
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6-minute walking distance will be measured according to standard criteria.
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Timepoint [4]
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Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)
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Secondary outcome [5]
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Quality of Life questionnaires
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Assessment method [5]
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Quality of life as assessed by the Short Form 36 (SF-36) questionnaire and Minnesota Living with Heart Failure Questionnaire
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Timepoint [5]
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Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)
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Secondary outcome [6]
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Unplanned Hospitalization
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Assessment method [6]
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Unplanned hospital admissions will be assessed by a combination of patient self-report, hospital record and/or treating physician interrogation. The reason, date and duration of hospitalization will be recorded Planned hospitalizations (hospital visits for elective or planned medical interventions) will excluded from this outcome
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Timepoint [6]
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Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)
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Secondary outcome [7]
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Ventricular arrhythmias requiring device therapy
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Assessment method [7]
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Ventricular arrhythmias requiring device therapy will be determined by implantable Cardioverter Defibrillator (ICD) interrogation records and clinical records. At each site, the number, duration and type (VT/VF) of device recorded arrhythmias will be recorded, as well as the need for device therapy (anti-tachycardia pacing and/or ICD shocks).
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Timepoint [7]
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Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)
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Eligibility
Key inclusion criteria
* Age = 18 years old
* Persistent (= 1 month) or permanent atrial fibrillation. Persistent AF will be where obtaining and maintaining sinus rhythm is deemed either not worthwhile, or to be ineffective in the long term, or where both the patient and physician accept the presence of AF, where rhythm control intervention is, by definition no longer pursued. Permanent AF is defined as atrial fibrillation where sinus rhythm cannot be restored.
* NYHA class II , III or ambulatory class IV heart failure
* Left Ventricular Ejection Fraction (LVEF) = 35% by objective criteria such as echocardiography, or cardiac MRI
* QRS duration on 12-lead ECG = 120ms
* Able and willing to comply with all pre-, post- and follow-up testing and requirements.
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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
* age < 18 years
* pregnancy
* previous AV nodal ablation
* Second or third degree AV block
* Inability to provide informed consent
* life expectancy less than 24 months due to co-morbid illness other than heart failure erg cancer, end-stage renal disease, liver failure
* Paroxysmal Atrial Fibrillation that self terminates within 7 days
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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
Open (masking not used)
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Who is / are masked / blinded?
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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
1/03/2013
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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
31/08/2020
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Sample size
Target
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Accrual to date
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Final
145
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,Perth, WAQLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Canberra Hospital - Canberra
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Recruitment hospital [2]
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Concord Hospital - Concord
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Recruitment hospital [3]
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John Hunter Hospital - New Lambton
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Recruitment hospital [4]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [5]
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Royal North Shore Hospital - Sydney
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Recruitment hospital [6]
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Royal Prince Alfred Hospital - Sydney
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Recruitment hospital [7]
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Fiona Stanley - Murdoch
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Recruitment hospital [8]
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Royal Brisbane Hospital - Brisbane
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Recruitment hospital [9]
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Prince Charles Hospital - Chermside
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Recruitment hospital [10]
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Townsville Hospital and Health Service - Douglas
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Recruitment hospital [11]
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Gold Coast University Hospital - Southport
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Recruitment hospital [12]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [13]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [14]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [15]
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Royal Hobart Hospital - Hobart
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Recruitment hospital [16]
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Monash Medical Centre - Clayton
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Recruitment hospital [17]
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Geelong Hospital - Geelong
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Recruitment hospital [18]
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Austin Hospital - Heidelberg
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Recruitment hospital [19]
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Melbourne Private Hospital - Melbourne
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Recruitment hospital [20]
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The Alfred Hospital - Melbourne
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Recruitment hospital [21]
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [22]
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Sir Charles Gairdner Hospital - Perth
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Recruitment hospital [23]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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2605 - Canberra
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Recruitment postcode(s) [2]
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- Concord
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Recruitment postcode(s) [3]
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2305 - New Lambton
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Recruitment postcode(s) [4]
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2031 - Randwick
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Recruitment postcode(s) [5]
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2065 - Sydney
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Recruitment postcode(s) [6]
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- Sydney
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Recruitment postcode(s) [7]
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6150 - Murdoch
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Recruitment postcode(s) [8]
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4209 - Brisbane
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Recruitment postcode(s) [9]
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4032 - Chermside
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Recruitment postcode(s) [10]
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4814 - Douglas
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Recruitment postcode(s) [11]
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4213 - Southport
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Recruitment postcode(s) [12]
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4102 - Woolloongabba
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Recruitment postcode(s) [13]
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5000 - Adelaide
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Recruitment postcode(s) [14]
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5042 - Bedford Park
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Recruitment postcode(s) [15]
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7000 - Hobart
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Recruitment postcode(s) [16]
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3168 - Clayton
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Recruitment postcode(s) [17]
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3220 - Geelong
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Recruitment postcode(s) [18]
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3084 - Heidelberg
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Recruitment postcode(s) [19]
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- Melbourne
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Recruitment postcode(s) [20]
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3050 - Parkville
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Recruitment postcode(s) [21]
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6009 - Perth
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Recruitment postcode(s) [22]
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- Perth
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Recruitment outside Australia
Country [1]
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Germany
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State/province [1]
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Gebäude 401/k
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Country [2]
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Germany
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State/province [2]
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Martinistr. 52 Gebäude Ost 50, 8. OG, Raum 842
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Country [3]
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Germany
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State/province [3]
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Cologne
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Country [4]
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Germany
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State/province [4]
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St Georg
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Country [5]
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Malaysia
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State/province [5]
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Kuala Lumpur
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Country [6]
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New Zealand
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State/province [6]
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Bay Of Plenty
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Country [7]
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New Zealand
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State/province [7]
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Auckland
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Country [8]
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New Zealand
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State/province [8]
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Hamilton
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Country [9]
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New Zealand
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State/province [9]
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Wellington
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Country [10]
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United Kingdom
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State/province [10]
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Middlesbrough
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Adelaide
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Medtronic
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Address [1]
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Other collaborator category [2]
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Commercial sector/industry
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Name [2]
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Abbott Medical Devices
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Address [2]
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Country [2]
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Other collaborator category [3]
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Commercial sector/industry
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Name [3]
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Boston Scientific Corporation
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
Cardiac resynchronization therapy (CRT) is a treatment for heart failure in patients who also suffer from ventricular dyssynchrony, a form of uncoordinated contraction of the ventricle (lower pumping chamber of the heart). In the past decade, CRT has become an established treatment for heart failure patients who are in normal rhythm, called sinus rhythm. An important subset of heart failure patients are those with atrial fibrillation (AF), who make up around 1 in 4 HF patients, and are over-represented amongst HF patients with more advanced symptoms. In heart failure patients with AF, CRT has proven not to be as effective as in sinus rhythm, due to competition between beats generated by the CRT device and beats conducted from the heart's own electrical conduction system. In the current study, we aim to test the hypothesis that ablating the AV node, which controls electrical conduction from the heart's atria (top chamber) to its ventricles (lower chambers), will improve survival and heart failure symptoms in CRT patients with co-existent AF. The results are important, because they will provide a way of passing on the benefits of CRT, such as improved survival, less heart failure symptoms, and better quality of life, to heart failure patients who also suffer from AF.
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Trial website
https://clinicaltrials.gov/study/NCT01522898
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prashanthan Sanders, MBBS PhD
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Address
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University of Adelaide
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01522898
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