Clinical trial NCT00662701: Ablation or Surgery for Atrial Fibrillation (AF) Treatment
Official title: Atrial Fibrillation: Ablation or Surgical Treatment; A Randomized Study Comparing Non-pharmacologic Therapy in Patients With Drug-refractory Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
name: AtriCure, Inc.
First posted: 2008-04-21
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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 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

Primary outcomes:
measure: Freedom from AF and/or secondary left atrial arrhythmias, lasting >60 sec, as determined by 7 day continuous Holter monitoring.
timeFrame: 6 months
measure: Safety and/or adverse events
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 and 12 Months
measure: Composite major complications, Serious Adverse Events, Serious Adverse Effects
timeFrame: 12 Months
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital Nieuwegein
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
Study officials:
affiliation: St. Antonius Hospital
name: Lucas Boersma, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Antonius Hospital
name: WimJan van Boven, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Lluis Mont, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Castella M, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boersma LV, Castella M, van Boven W, Berruezo A, Yilmaz A, Nadal M, Sandoval E, Calvo N, Brugada J, Kelder J, Wijffels M, Mont L. Atrial fibrillation catheter ablation versus surgical ablation treatment (FAST): a 2-center randomized clinical trial. Circulation. 2012 Jan 3;125(1):23-30. doi: 10.1161/CIRCULATIONAHA.111.074047. Epub 2011 Nov 14.