Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF (CASTLE-AF)
|Atrial Fibrillation Heart Failure||Procedure: Radiofrequency ablation Other: Conventional treatment||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Catheter Ablation Versus Standard Conventional Treatment in Patients With Left Ventricular Dysfunction and Atrial Fibrillation|
- All-cause mortality or worsening heart failure requiring unplanned hospitalization [ Time Frame: 7 years ]
- 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 [ Time Frame: 7 years ]
|Actual Study Start Date:||January 2008|
|Study Completion Date:||March 2017|
|Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
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.
Procedure: Radiofrequency ablation
Radiofrequency ablation of atrial fibrillation
Active Comparator: 2
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.
Other: 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.
Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice; its incidence and prevalence increase exponentially with increasing age and it is associated with increased mortality, more frequent hospitalization, and decreased quality of life.
An initial approach to the cure of patients suffering from AF was surgical intervention with the Maze procedure, which involved the creation of linear lesions in the atria to break the re-entrant wavefronts responsible for maintenance of AF. Subsequently, less invasive procedures have been developed to achieve the same results. One of them is catheter based radio frequency ablation, in which a catheter is placed in the heart percutaneously, followed by application of electrical energy to the target regions, thereby creating a permanent lesion.
The origin of AF is often localized in the pulmonary veins (PVs); therefore one common approach is to ablate them in order to electrically isolate them from the left atrium (LA). Several strategies have been developed, such as linear, segmental, circumferential, and double-lasso.
Additionally, other anatomical regions such as the right atrium (RA), superior vena cava (SVC), and coronary sinus (CS) can be ablated in order to eliminate non-PV drivers of AF.
Heart failure (HF) is frequently a chronic and lethal condition, causing substantial morbidity and, after initial diagnosis, results in mortality rates which come close to or exceed those of many malignancies.
Both AF and HF have a significant impact on the health care expenditures. The two diseases often coexist, there is a complex interaction between them: many of the processes that predispose to HF, such as hypertension, diabetes, coronary artery disease, and valvular heart disease, are also risk factors for the development of AF. Similarly, many of the echocardiographic findings that are common in patients with HF, including LA enlargement, increased left ventricular (LV) wall thickness, and reduced LV fractional shortening, predispose patients in the development of AF.
In small groups of patients suffering from HF and AF, radio frequency ablation has been performed; the restoration of sinus rhythm resulted in the improvement of quality of life, exercise performance, and cardiac parameters like ejection fraction and fractional shortening. It is still unknown if such therapy is also effective in reducing mortality and morbidity.
CASTLE-AF is a prospective, unblinded, randomized, multicenter study whose aim is to compare the effect of radio frequency catheter-based ablation on mortality and morbidity with that of conventional treatment in HF subjects with AF. About 420 patients with LV dysfunction (ejection fraction ≤ 35%) and New York Heart Association (NYHA) class ≥ II, already implanted with a dual chamber implantable cardioverter defibrillator (ICD) with Home Monitoring® capabilities, will be enrolled and randomized 1:1 to undergo either AF ablation or standard treatment as indicated in the American College of Cardiology (ACC)/American Heart Association (AHA)/European Society of Cardiology (ESC) 2006 guidelines for the management of patients with AF. In addition to planned and unplanned visits, the ablated patients will be constantly monitored remotely via Home Monitoring®, in order to detect any recurrences of AF episodes, even if non-symptomatic or short in duration, during an observational period of minimum 3 years for each patient.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00643188
|Royal Adelaide Hospital|
|Royal Brisbane and Women's Hospital|
|A. ö. Krankenhaus der Elisabethinen Linz|
|Allgemeines Krankenhaus der Stadt Wien|
|Herz- und Diabeteszentrum Nordrhein-Westfalen|
|Bad Oeynhausen, Germany|
|Charité Campus Mitte|
|Charité Campus Virchow-Klinikum|
|Franz-Volhard-Klinik, Universitätsklinikum Charité|
|Vivantes-Klinikum am Urban|
|Städtische Kliniken Bielefeld|
|St. Marien Hospital|
|Zentralkrankenhaus Links der Weser, Siebels & Langes Partnerschaft|
|Evangelisches Krankenhaus Düsseldorf|
|Kardiocentrum Frankfurt an der Klinik Rotes Kreuz|
|Frankfurt am Main, Germany|
|Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald|
|Deutsches Herzzentrum München|
|Semmelweis Medical University|
|The Debrecen University of Medicine|
|Erasmus Medical Center|
|National Institute of Cardiology|
|HRD Surgical Department; Federal Centre of Cardiovascular Surgery|
|Krasnoyarsk, Russian Federation|
|N.S.B.R.I. of Circulation Pathology|
|Novosibirsk, Russian Federation|
|Arrhythmology Department; Federal Heart Blood and Endocrinology Center n.a. V. A. Almazov|
|Saint Petersburg, Russian Federation|
|FSBI Research Institute of Cardiology, Siberian Branch of RAMS|
|Tomsk, Russian Federation|
|The Heart Hospital|
|London, United Kingdom|
|Study Chair:||Johannes Brachmann, Prof. Dr.||Klinikum Coburg, Germany|
|Study Chair:||Nassir F. Marrouche, Dr.||Division of Cardiology, University of Utah Health Sciences Cente, Salt Lake City, Utah, United States|