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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00643188




Registration number
NCT00643188
Ethics application status
Date submitted
22/02/2008
Date registered
26/03/2008

Titles & IDs
Public title
Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF
Scientific title
Catheter Ablation Versus Standard Conventional Treatment in Patients With Left Ventricular Dysfunction and Atrial Fibrillation
Secondary ID [1] 0 0
EP020
Universal Trial Number (UTN)
Trial acronym
CASTLE-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
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: Surgery - Radiofrequency ablation
Other interventions - Conventional treatment

Experimental: 1 - Radiofrequency ablation of atrial fibrillation:

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.

Active comparator: 2 - Conventional treatment:

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.


Treatment: Surgery: Radiofrequency ablation
Radiofrequency ablation of atrial fibrillation

Other interventions: Conventional treatment
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.
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-cause mortality or worsening heart failure requiring unplanned hospitalization
Timepoint [1] 0 0
7 years
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
7 years

Eligibility
Key inclusion criteria
* Symptomatic paroxysmal or persistent atrial fibrillation
* Failure or intolerance of antiarrhythmic drug therapy or unwillingness to take antiarrhythmic drugs
* Left Ventricular Ejection Fraction <= 35%
* NYHA >= II
* ICD for primary or secondary prevention with atrial sensing capabilities or Cardiac Resynchronization Therapy plus Defibrillator (CRT-D) device, both with Home Monitoring® technology already implanted
* Patient is willing and able to comply with the protocol and has written informed consent
* Age >= 18 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 to enrollment
* Untreated hypothyroidism or hyperthyroidism
* Enrollment in another investigational drug or device study
* Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age
* 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

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
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
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2017
Sample size
Target
Accrual to date
Final
398
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Herston
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Linz
Country [2] 0 0
Austria
State/province [2] 0 0
Wien
Country [3] 0 0
Germany
State/province [3] 0 0
Bad Oeynhausen
Country [4] 0 0
Germany
State/province [4] 0 0
Berlin
Country [5] 0 0
Germany
State/province [5] 0 0
Bielefeld
Country [6] 0 0
Germany
State/province [6] 0 0
Bonn
Country [7] 0 0
Germany
State/province [7] 0 0
Bremen
Country [8] 0 0
Germany
State/province [8] 0 0
Coburg
Country [9] 0 0
Germany
State/province [9] 0 0
Düsseldorf
Country [10] 0 0
Germany
State/province [10] 0 0
Frankfurt am Main
Country [11] 0 0
Germany
State/province [11] 0 0
Greifswald
Country [12] 0 0
Germany
State/province [12] 0 0
Landshut
Country [13] 0 0
Germany
State/province [13] 0 0
Lüdenscheid
Country [14] 0 0
Germany
State/province [14] 0 0
München
Country [15] 0 0
Germany
State/province [15] 0 0
Paderborn
Country [16] 0 0
Germany
State/province [16] 0 0
Rostock
Country [17] 0 0
Hungary
State/province [17] 0 0
Budapest
Country [18] 0 0
Hungary
State/province [18] 0 0
Debrecen
Country [19] 0 0
Netherlands
State/province [19] 0 0
Nieuwegein
Country [20] 0 0
Netherlands
State/province [20] 0 0
Rotterdam
Country [21] 0 0
Netherlands
State/province [21] 0 0
Zwolle
Country [22] 0 0
Poland
State/province [22] 0 0
Warszawa
Country [23] 0 0
Russian Federation
State/province [23] 0 0
Krasnoyarsk
Country [24] 0 0
Russian Federation
State/province [24] 0 0
Novosibirsk
Country [25] 0 0
Russian Federation
State/province [25] 0 0
Saint Petersburg
Country [26] 0 0
Russian Federation
State/province [26] 0 0
Tomsk
Country [27] 0 0
United Kingdom
State/province [27] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biotronik SE & Co. KG
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Johannes Brachmann, Prof. Dr.
Address 0 0
Klinikum Coburg, Germany
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
It is planned to publish results of this investigation in peer-reviewed journals (online: open-access), but it is not yet decided to annex individual participant data (IPD).


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/NCT00643188