Ablation or Surgery for Atrial Fibrillation (AF) Treatment

NCT00662701 | Completed DMC

• 1 other identifier: R-06.30A/FAST
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 2

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

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Freedom from AF and/or secondary left atrial arrhythmias, lasting >60 sec, as determined by 7 day continuous Holter monitoring.

  6 months

• Safety and/or adverse events

  6 months

Secondary Outcomes (2)

• 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

  6 and 12 Months

• Composite major complications, Serious Adverse Events, Serious Adverse Effects

  12 Months

Study Arms (2)

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

2

ACTIVE COMPARATOR

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

Procedure: Surgical Ablation

Interventions

Catheter Ablation 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.

1

Surgical Ablation PROCEDURE

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

2

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Antonius Hospital: lead
• Hospital Clinic of Barcelona: collaborator
• AtriCure, Inc.: collaborator

Study Sites (2)

St. Antonius Hospital Nieuwegein

Nieuwegein, 3430, Netherlands

Location

Hospital Clinic Barcelona

Barcelona, Spain

Location

Related Publications (1)

• 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.

  PMID: 22082673 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Lucas Boersma, MD/PhD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

• WimJan van Boven, MD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

• Lluis Mont, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• Castella M, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Study Record Dates

• First Submitted: March 25, 2008
• First Posted: April 21, 2008
• Study Start: May 1, 2007
• Primary Completion: November 1, 2012
• Study Completion: January 1, 2013
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

ES (1); NL (1)