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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record athttps://clinicaltrials.gov/ct2/show/NCT00643188
Registration number
NCT00643188
Ethics application status
Date submitted
22/02/2008
Date registered
26/03/2008
Date last updated
18/05/2017
Titles & IDs
Public title
Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF
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Scientific title
Catheter Ablation Versus Standard Conventional Treatment in Patients With Left Ventricular Dysfunction and Atrial Fibrillation
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Secondary ID [1]00
EP020
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Universal Trial Number (UTN)
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Trial acronym
CASTLE-AF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation00
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Heart Failure00
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Condition category
Condition code
Cardiovascular 0000
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Coronary heart disease
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Cardiovascular 0000
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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 - Radiofrequency ablation Experimental: 1 - Radiofrequency ablation of atrial fibrillation: Active Comparator: 2 - Conventional treatment: Treatment: Surgery: Radiofrequency ablation Other interventions: Conventional treatment
Other interventions - Conventional treatment
Subjects assigned to the catheter AF ablation strategy will undergo ablation within 48 hours after baseline evaluation. The aim of the procedure is to achieve isolation of all Pulmonary Veins (PVs) and to restore sinus rhythm. Only radiofrequency catheter based AF ablation is permitted; other methods, like cryoablation, ultrasound and laser, are not permitted in this study.
Before ablation, a transesophageal echocardiogram must be performed in order to rule out presence of atrial thrombi.
Anticoagulation should be initiated, or continued, for at least six months post ablation. Six months after successful ablation and in absence of any recurrence of AF, antiarrhythmic drugs should be discontinued.
Subjects assigned to the conventional treatment strategy will be treated according to current guidelines for the management of patients with chronic heart failure and/or atrial fibrillation. Efforts to maintain sinus rhythm in this study arm are recommended.
Anticoagulation will be initiated, if not already started, and maintained throughout the study according to current guidelines.
Radiofrequency ablation of atrial fibrillation
The best medical treatment according to the ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult and the ACC/AHA/ESC 2006 Guidelines for Management of Patients with Atrial Fibrillation.
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Intervention code [1]00
Treatment: Surgery
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Intervention code [2]00
Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]00
All-cause mortality or worsening heart failure requiring unplanned hospitalization
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Timepoint [1]00
7 years
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Secondary outcome [1]00
All-cause mortality Cardiovascular mortality Unplanned hospitalization due to cardiovascular reason Worsening heart failure requiring unplanned hospitalization Cerebrovascular accidents Left ventricular function Exercise tolerance Quality of life
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Timepoint [1]00
7 years
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Eligibility
Key inclusion criteria
- Symptomatic paroxysmal or persistent atrial fibrillation - Failure or intolerance of antiarrhythmic drug therapy or unwillingness to take - Left Ventricular Ejection Fraction <= 35% - NYHA >= II - ICD for primary or secondary prevention with atrial sensing capabilities or Cardiac - Patient is willing and able to comply with the protocol and has written informed - Age >= 18 years
antiarrhythmic drugs
Resynchronization Therapy plus Defibrillator (CRT-D) device, both with Home
Monitoring® technology already implanted
consent
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Minimum age
18Years
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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
- Contraindication for chronic anticoagulation therapy and heparin - Documented left atrial diameter > 6 cm - Previous left heart ablation procedure for atrial fibrillation - Acute coronary syndrome, cardiac surgery, angioplasty or stroke within 2 months prior - Untreated hypothyroidism or hyperthyroidism - Enrollment in another investigational drug or device study - Woman currently pregnant or breastfeeding or not using reliable contraceptive measures - Mental or physical inability to take part in the study - Listed for heart transplant - Cardiac assist device implanted - Planned cardiovascular intervention - Life expectancy = 12 months - Uncontrolled hypertension - Requirement for dialysis due to terminal renal failure - Participation in another telemonitoring concept
to enrollment
during fertility age
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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 concealmentprocedures)
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Methods used to generate the sequence in which subjects will be randomised (sequencegeneration)
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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
Phase 4
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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
1/01/2008
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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
1/03/2017
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Sample size
Target
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Accrual to date
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Final
398
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]00
Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]00
Royal Brisbane and Women's Hospital - Herston
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Recruitment postcode(s) [1]00
- Adelaide
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Recruitment postcode(s) [2]00
- Herston
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Recruitment outside Australia
Country [1]00
Austria
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State/province [1]00
Linz
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Country [2]00
Austria
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State/province [2]00
Wien
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Germany
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State/province [3]00
Bad Oeynhausen
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Germany
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Berlin
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Germany
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Bielefeld
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Germany
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Bonn
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Germany
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Bremen
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Germany
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Coburg
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Germany
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Düsseldorf
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Germany
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Frankfurt am Main
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Germany
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Greifswald
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Germany
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Landshut
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Germany
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Lüdenscheid
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Germany
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München
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Germany
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State/province [15]00
Paderborn
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Germany
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State/province [16]00
Rostock
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Country [17]00
Hungary
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Budapest
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Hungary
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State/province [18]00
Debrecen
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Country [19]00
Netherlands
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Nieuwegein
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Netherlands
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Rotterdam
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Netherlands
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Zwolle
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Poland
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Warszawa
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Russian Federation
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State/province [23]00
Krasnoyarsk
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Country [24]00
Russian Federation
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State/province [24]00
Novosibirsk
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Russian Federation
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State/province [25]00
Saint Petersburg
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Country [26]00
Russian Federation
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State/province [26]00
Tomsk
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Country [27]00
United Kingdom
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State/province [27]00
London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Biotronik SE & Co. KG
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice. The
incidence and prevalence of AF increase exponentially with increasing age and AF is
associated with higher mortality, more frequent hospitalization, and lower quality of life.
Furthermore, AF is often associated with heart failure. The majority of AF is initiated by
ectopic foci found primarily in the pulmonary veins. It was shown that catheter ablation of
those veins could eliminate episodes of AF. In patients with heart failure, catheter ablation
could improve cardiac function, symptoms and quality of life. It remains still unknown
whether AF ablation is more effective than conventional treatment in terms of mortality and
morbidity.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00643188
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Trial related presentations / publications
Marrouche NF, Brachmann J; CASTLE-AF Steering Committee. Catheter ablation versus standard conventional treatment in patients with left ventricular dysfunction and atrial fibrillation (CASTLE-AF) - study design. Pacing Clin Electrophysiol. 2009 Aug;32(8):987-94. doi: 10.1111/j.1540-8159.2009.02428.x.
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Public notes
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Contacts
Principal investigator
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Johannes Brachmann, Prof. Dr.
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Address00
Klinikum Coburg, Germany
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Phone00
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Email00
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Contact person for public queries
Name00
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Address00
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Email00
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Contact person for scientific queries
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
