Ablation or Surgery for Atrial Fibrillation (AF) Treatment - Full Text View

Sponsors and Collaborators:	St. Antonius Hospital Hospital Clinic of Barcelona AtriCure, Inc.
Information provided by:	St. Antonius Hospital
ClinicalTrials.gov Identifier:	NCT00662701

Purpose

The purpose of this study is to compare 2 invasive strategies for Atrial Fibrillation treatment, Endocardial catheter ablation isolation of the Pulmonary veins versus minimally invasive thoracoscopic surgical epicardial isolation. Both strategies are in use for several years now, and have been reported as a successful strategy with success rates of 60-90%. However, it is not known which technique is preferable in a given patient population in terms of efficacy to cure AF, safety, or patient discomfort. Therefore, in the present trial a randomized study is proposed to provide more insight into the relative merits of both techniques

Condition	Intervention
Atrial Fibrillation	Procedure: Catheter Ablation Procedure: Surgical Ablation

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Atrial Fibrillation: Ablation or Surgical Treatment; A Randomized Study Comparing Non-Pharmacologic Therapy in Patients With Drug-Refractory Atrial Fibrillation

Further study details as provided by St. Antonius Hospital:

Primary Outcome Measures:

Freedom from AF and/or secondary left atrial arrhythmias, lasting >60 sec, as determined by 7 day continuous Holter monitoring. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Safety and/or adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Freedom of AADs, Decrease in the frequency and duration of AF episodes, Decrease in the number of AF related hospital admissions, Improvement in quality of life internet Follow Up, Decrease in number of cardioversions, PM implant [ Time Frame: 6 and 12 Months ] [ Designated as safety issue: No ]
Composite major complications, Serious Adverse Events, Serious Adverse Effects [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	May 2007
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Catheter RF ablation with complete circumferential ablation around the right and PVs, and additional lines between the lower and upper PVs, and towards the mitral valve ring.	Procedure: Catheter Ablation RF ablation with complete circumferential ablation around the right and PVs, optional additional lines between the lower and upper PVs, and towards the mitral valve ring.
2: Active Comparator Minimal invasive thoracoscopic surgery including isolation of the PVs by AtriCure and removal of the LAA.	Procedure: Surgical Ablation Minimal invasive thoracoscopic surgery including isolation of the PVs by AtriCure and removal of the LAA.

Detailed Description:

Atrial Fibrillation is the most common cardiac arrhythmia, affecting millions of people around the world. It is a large burden on health care resources and may even lead to a shorter life expectancy. Drug treatment has been found insufficient and sometimes even hazardous to the pt. Traditionally, there was only one invasive approach available, being MAZE 3 procedure by means of full open chest cardiac surgery. This was a very invasive approach, limited to only a few skilled surgeons, with insufficient options to treat large pt volume.

With the discovery that AF often is initiated and maintained by electrical instability inside and around the Pulmonary Veins, catheter ablation is now a widely accepted early invasive strategy to cure AF. Success rates of 60% to 90% have been reported, depending on technique employed and the type of AF (Resp, chronic versus paroxysmal)

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient has a history of symptomatic paroxysmal and/or persistent atrial fibrillation for at least 12 months
Patient is refractory to or intolerant of at least one antiarrhythmic drug
Patient has an enlarged atrium >40 mm and/or Patient has a failed previous catheter ablation and/or Patient has additional risk factors such as hypertension, increasing age
Patient is between 30 and 70 years of age
Patient is mentally able and willing to give informed consent

Exclusion Criteria:

Cardiac ablation or surgical cardiac procedure in the last 3 months
Previous cardiac tamponade
Previous stroke or TIA
Left atrial thrombus
Left atrial size >65 mm
Left ventricular ejection fraction <45 %
Active infection or sepsis
Pregnancy
Unstable angina
Myocardial infarction (MI) within previous 3 months
Atrial fibrillation is secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause
History of blood clotting abnormalities
Known sensitivity to heparin or warfarin
Life expectancy is less than 12 months
Patient is involved in another clinical study involving an investigational drug or device
Pleural adhesions
Prior thoracotomy
Prior cardiac surgery
Elevated hemi diaphragm

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662701

Contacts

Contact: Lucas V Boersma, MD/PhD	31-30-609-3637	l.boersma@antonius.net
Contact: WimJan van Boven, MD	31-30-609-2108	w.boven@antonius.net

Locations

Netherlands
St. Antonius Hospital Nieuwegein	Recruiting
Nieuwegein, Netherlands, 3430
Principal Investigator: Lucas Boersma, MD
Principal Investigator: WimJan van Boven, MD
Spain
Hospital Clinic Barcelona	Recruiting
Barcelona, Spain
Principal Investigator: Lluis Mont, MD
Principal Investigator: M Castella, MD

Sponsors and Collaborators

St. Antonius Hospital

Hospital Clinic of Barcelona

AtriCure, Inc.

Investigators

Principal Investigator:	Lucas Boersma, MD/PhD	St.Antonius Hospital Nieuwegein
Principal Investigator:	WimJan van Boven, MD	St.Antonius Hospital Nieuwegein
Principal Investigator:	Lluis Mont, MD	Hospital Clinic Barcelona
Principal Investigator:	Castella M, MD	Hospital Clinic Barcelona

More Information

No publications provided

Responsible Party:	St. Antonius Hospital Nieuwegein ( L.V.A. Boersma )
Study ID Numbers:	R-06.30A/FAST
Study First Received:	March 25, 2008
Last Updated:	April 17, 2008
ClinicalTrials.gov Identifier:	NCT00662701 History of Changes
Health Authority:	Netherlands: Dutch Health Care Inspectorate

Keywords provided by St. Antonius Hospital:

Atrial Fibrillation

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009