Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF (CASTLE-AF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Biotronik SE & Co. KG
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT00643188
First received: February 22, 2008
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Heart Failure
Procedure: Radiofrequency ablation
Other: Conventional treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Catheter Ablation Versus Standard Conventional Treatment in Patients With Left Ventricular Dysfunction and Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • All-cause mortality or worsening heart failure requiring unplanned hospitalization [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 420
Study Start Date: January 2008
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Procedure: Radiofrequency ablation
Radiofrequency ablation of atrial fibrillation
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.

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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643188

Contacts
Contact: Christoph Strehl, Dr. +49-30-68905-1318 christoph.strehl@biotronik.com
Contact: Nicole Lobitz +49 30 68905 1310 Nicole.Lobitz@biotronik.com

  Hide Study Locations
Locations
Australia
Royal Adelaide Hospital Recruiting
Adelaide, Australia
Principal Investigator: Prashanthan Sanders, Prof.         
Royal Brisbane and Women's Hospital Active, not recruiting
Herston, Australia
Royal Melbourne Hospital Withdrawn
Parkville, Australia
Westmead Hospital Completed
Westworthville, Australia
Austria
A. ö. Krankenhaus der Elisabethinen Linz Active, not recruiting
Linz, Austria
Allgemeines Krankenhaus der Stadt Wien Recruiting
Wien, Austria
Principal Investigator: Herwig Schmidinger, Prof. Dr.         
Belgium
AZ St.-Jan Brugge Withdrawn
Brugge, Belgium
Cliniques Universitaires de Mont Godinne Withdrawn
Yvoir, Belgium
Czech Republic
IKEM Praha Withdrawn
Praha, Czech Republic
Germany
Zentralklinik Bad Berka Withdrawn
Bad Berka, Germany
Herz- und Diabeteszentrum Nordrhein-Westfalen Active, not recruiting
Bad Oeynhausen, Germany
Charité Campus Virchow-Klinikum Active, not recruiting
Berlin, Germany
Charité Campus Mitte Active, not recruiting
Berlin, Germany
Vivantes-Klinikum am Urban Recruiting
Berlin, Germany
Principal Investigator: Christian Ewertsen, Dr. med.         
Deutsches Herzzentrum Berlin Withdrawn
Berlin, Germany
Franz-Volhard-Klinik, Universitätsklinikum Charité Completed
Berlin, Germany
Städtische Kliniken Bielefeld Active, not recruiting
Bielefeld, Germany
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Withdrawn
Bochum, Germany
St. Marien Hospital Recruiting
Bonn, Germany
Principal Investigator: Stefan Schlüter, Dr. med.         
Zentralkrankenhaus Links der Weser, Siebels & Langes Partnerschaft Recruiting
Bremen, Germany
Principal Investigator: Jürgen Siebels, Dr. med.         
Klinikum Coburg Recruiting
Coburg, Germany
Principal Investigator: Johannes Brachmann, Prof. Dr.         
Evangelisches Krankenhaus Düsseldorf Completed
Düsseldorf, Germany
Kardiocentrum Frankfurt an der Klinik Rotes Kreuz Terminated
Frankfurt am Main, Germany
Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald Active, not recruiting
Greifswald, Germany
Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem Withdrawn
Göttingen, Germany
Universitätsklinikum Göttingen Not yet recruiting
Göttingen, Germany
Principal Investigator: Markus Zabel, Prof. Dr.         
Medizinische Hochschule Hannover Withdrawn
Hannover, Germany
Herzzentrum Konstanz Withdrawn
Konstanz, Germany
Krankenhaus Porz am Rhein Withdrawn
Köln, Germany
Krankenhaus Landshut-Achdorf Recruiting
Landshut, Germany
Principal Investigator: Bernhard Zrenner, OA Dr. med.         
Klinikum Lüdenscheid Terminated
Lüdenscheid, Germany
Klinikum der Johannes-Gutenberg-Universität Mainz Withdrawn
Mainz, Germany
Isar Zentrum Not yet recruiting
Munich, Germany
Principal Investigator: Thorsten Lewalter, Prof.Dr.         
Klinik Augustinum München Withdrawn
München, Germany
Deutsches Herzzentrum München Terminated
München, Germany
St. Vincenz-Krankenhaus Recruiting
Paderborn, Germany
Principal Investigator: Andreas Götte, Prof. Dr.         
Universitätsklinikum Rostock Recruiting
Rostock, Germany
Principal Investigator: Dietmar Bänsch, Prof. Dr.         
Universitätsklinikum Tübingen Withdrawn
Tübingen, Germany
Hungary
Semmelweis Medical University Recruiting
Budapest, Hungary
Principal Investigator: Béla Merkely, Prof. Dr.         
The Debrecen University of Medicine Active, not recruiting
Debrecen, Hungary
Italy
Ospedale Cardinal Massaia Withdrawn
Asti, Italy
Istituto Clinico Mater Domini Withdrawn
Castellanza, Italy
Presidio Osped. Riunito sede di Cirié Withdrawn
Cirié, Italy
Policlinico Casilino Withdrawn
Rome, Italy
IRCCS, Multimedica Withdrawn
Sesto San Giovanni, Italy
Netherlands
Antonius Ziekenhuis Active, not recruiting
Nieuwegein, Netherlands
Erasmus Medical Center Recruiting
Rotterdam, Netherlands
Principal Investigator: Thomas Szili-Torok, Dr.         
Isala Klinieken Active, not recruiting
Zwolle, Netherlands
Poland
National Institute of Cardiology Recruiting
Warszawa, Poland, 04-628
Principal Investigator: Lukasz Szumowski, Prof. Dr.         
Russian Federation
HRD Surgical Department; Federal Centre of Cardiovascular Surgery Recruiting
Krasnoyarsk, Russian Federation, 660020
Contact: Eduard Ivanitskiy, Dr.       edwiner@krascor.ru   
Principal Investigator: Eduard Ivanitskiy, Dr.         
Bakoulev Scientific Center for Cardiovascular Surgery of the Russian Academy of Medical Sciences Withdrawn
Moscow, Russian Federation, 121552
N.S.B.R.I. of Circulation Pathology Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Anastasia Sharygina    +7 913 935 73 64    a_sharygina@nricp.ru   
Contact: Alexander Romanov, Dr.       abromanov@mail.ru   
Principal Investigator: Evgeny Pokushalov, Dr.         
Arrhythmology Department; Federal Heart Blood and Endocrinology Center n.a. V. A. Almazov Recruiting
Saint Petersburg, Russian Federation, 197341
Contact: Dimitry Lebedev, MD, PhD       lebedevdmitry@mail.ru   
Principal Investigator: Dmitry Lebedev, MD, PhD         
FSBI Research Institute of Cardiology, Siberian Branch of RAMS Recruiting
Tomsk, Russian Federation, 634012
Contact: Sergey Popov, Prof. Dr.       psv@cardio.tsu.ru   
Principal Investigator: Sergey Popov, Prof. Dr.         
Switzerland
HUG Hopitaux Universitaires de Genève Withdrawn
Geneve, Switzerland
Cardiocentro Ticino Withdrawn
Lugano, Switzerland
United Kingdom
St. Bartholomew's Hospital Withdrawn
London, United Kingdom
The Heart Hospital Recruiting
London, United Kingdom
Principal Investigator: Anthony Chow, Dr.         
St. Thomas Hospital Withdrawn
London, United Kingdom
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT00643188     History of Changes
Other Study ID Numbers: EP020
Study First Received: February 22, 2008
Last Updated: June 17, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biotronik SE & Co. KG:
Atrial fibrillation
Ablation
Heart failure
Home Monitoring

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Failure
Ventricular Dysfunction, Left
Ventricular Dysfunction
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014