Ablation or Surgery for Atrial Fibrillation (AF) Treatment

Atrial Fibrillation Clinical Trial

— FAST  

Official title:

Atrial Fibrillation: Ablation or Surgical Treatment; A Randomized Study Comparing Non-pharmacologic Therapy in Patients With Drug-refractory Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00662701
• Other study ID #: R-06.30A/FAST
• Status: Completed
• Phase: N/A
• First received: March 25, 2008
• Last updated: November 18, 2015
• Start date: May 2007
• Est. completion date: January 2013

Study information

• Verified date: November 2015
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Netherlands	St. Antonius Hospital Nieuwegein	Nieuwegein
Spain	Hospital Clinic Barcelona	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
St. Antonius Hospital	AtriCure, Inc., Hospital Clinic of Barcelona

Countries where clinical trial is conducted

Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from AF and/or secondary left atrial arrhythmias, lasting >60 sec, as determined by 7 day continuous Holter monitoring.		6 months	No
Primary	Safety and/or adverse events		6 months	Yes
Secondary	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	No
Secondary	Composite major complications, Serious Adverse Events, Serious Adverse Effects		12 Months	Yes