Ablation or Surgery for Atrial Fibrillation (AF) Treatment

NCT ID: NCT00662701

Last Updated: 2015-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2013-01-31

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)

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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.

Group Type: ACTIVE_COMPARATOR

Catheter Ablation

Intervention Type: PROCEDURE

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

Minimal invasive thoracoscopic surgery including isolation of the PVs by AtriCure and removal of the LAA.

Group Type: ACTIVE_COMPARATOR

Surgical Ablation

Intervention Type: PROCEDURE

Minimal invasive thoracoscopic surgery including isolation of the PVs by AtriCure and removal of the LAA.

Interventions

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.

Intervention Type: PROCEDURE

Surgical Ablation

Minimal invasive thoracoscopic surgery including isolation of the PVs by AtriCure and removal of the LAA.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: collaborator

AtriCure, Inc.

INDUSTRY

Sponsor Role: collaborator

St. Antonius Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lucas Boersma

Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucas Boersma, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

WimJan van Boven, MD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Lluis Mont, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Castella M, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

St. Antonius Hospital Nieuwegein

Nieuwegein, , Netherlands

Hospital Clinic Barcelona

Barcelona, , Spain

Countries

Netherlands; Spain

References

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.

Reference Type: DERIVED

PMID: 22082673 (View on PubMed)

Other Identifiers

R-06.30A/FAST

Identifier Type: -

Identifier Source: org_study_id