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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

398

participants targeted

Target at P75+ for phase_4 atrial-fibrillation

Timeline

Completed

Started Jan 2008

Longer than P75 for phase_4 atrial-fibrillation

Geographic Reach

7 countries

30 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.2 years study duration

Study Start

First participant enrolled

January 1, 2008

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2008

Completed

1 month until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed

8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed

Last Updated

May 18, 2017

Status Verified

May 1, 2017

Enrollment Period

9.2 years

First QC Date

February 22, 2008

Last Update Submit

May 17, 2017

Conditions

Atrial Fibrillation Heart Failure

Keywords

Atrial fibrillationAblationHeart failureHome Monitoring

Outcome Measures

Primary Outcomes (1)

All-cause mortality or worsening heart failure requiring unplanned hospitalization
7 years

Secondary Outcomes (1)

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
7 years

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

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

Interventions

Radiofrequency ablationPROCEDURE

Radiofrequency ablation of atrial fibrillation

Conventional treatmentOTHER

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.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biotronik SE & Co. KGlead

Study Sites (32)

Royal Adelaide Hospital

Adelaide, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Australia

Location

A. ö. Krankenhaus der Elisabethinen Linz

Linz, Austria

Location

Allgemeines Krankenhaus der Stadt Wien

Vienna, Austria

Location

Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, Germany

Location

Charité Campus Mitte

Berlin, Germany

Location

Charité Campus Virchow-Klinikum

Berlin, Germany

Location

Franz-Volhard-Klinik, Universitätsklinikum Charité

Berlin, Germany

Location

Vivantes-Klinikum am Urban

Berlin, Germany

Location

Städtische Kliniken Bielefeld

Bielefeld, Germany

Location

St. Marien Hospital

Bonn, Germany

Location

Zentralkrankenhaus Links der Weser, Siebels & Langes Partnerschaft

Bremen, Germany

Location

Klinikum Coburg

Coburg, Germany

Location

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, Germany

Location

Kardiocentrum Frankfurt an der Klinik Rotes Kreuz

Frankfurt am Main, Germany

Location

Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald

Greifswald, Germany

Location

Krankenhaus Landshut-Achdorf

Landshut, Germany

Location

Klinikum Lüdenscheid

Lüdenscheid, Germany

Location

Deutsches Herzzentrum München

München, Germany

Location

St. Vincenz-Krankenhaus

Paderborn, Germany

Location

Universitätsklinikum Rostock

Rostock, Germany

Location

Semmelweis Medical University

Budapest, Hungary

Location

The Debrecen University of Medicine

Debrecen, Hungary

Location

Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Isala Klinieken

Zwolle, Netherlands

Location

National Institute of Cardiology

Warsaw, Poland

Location

HRD Surgical Department; Federal Centre of Cardiovascular Surgery

Krasnoyarsk, Russia

Location

N.S.B.R.I. of Circulation Pathology

Novosibirsk, Russia

Location

Arrhythmology Department; Federal Heart Blood and Endocrinology Center n.a. V. A. Almazov

Saint Petersburg, Russia

Location

FSBI Research Institute of Cardiology, Siberian Branch of RAMS

Tomsk, Russia

Location

The Heart Hospital

London, United Kingdom

Location

Related Publications (3)

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.
PMID: 19659616BACKGROUND
Brachmann J, Sohns C, Andresen D, Siebels J, Sehner S, Boersma L, Merkely B, Pokushalov E, Sanders P, Schunkert H, Bansch D, Dagher L, Zhao Y, Mahnkopf C, Wegscheider K, Marrouche NF. Atrial Fibrillation Burden and Clinical Outcomes in Heart Failure: The CASTLE-AF Trial. JACC Clin Electrophysiol. 2021 May;7(5):594-603. doi: 10.1016/j.jacep.2020.11.021. Epub 2021 Feb 24.
PMID: 33640355DERIVED
Marrouche NF, Brachmann J, Andresen D, Siebels J, Boersma L, Jordaens L, Merkely B, Pokushalov E, Sanders P, Proff J, Schunkert H, Christ H, Vogt J, Bansch D; CASTLE-AF Investigators. Catheter Ablation for Atrial Fibrillation with Heart Failure. N Engl J Med. 2018 Feb 1;378(5):417-427. doi: 10.1056/NEJMoa1707855.
PMID: 29385358DERIVED

MeSH Terms

Conditions

Atrial FibrillationHeart Failure

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

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
STUDY CHAIR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 22, 2008

First Posted

March 26, 2008

Study Start

January 1, 2008

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

May 18, 2017

Record last verified: 2017-05

Locations

NL(3)DE(17)HU(2)PL(1)AU(2)GB(1)RU(4)

Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (32)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (32)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations