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Ablation or Surgery for Atrial Fibrillation (AF) Treatment (FAST)

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Catheter Ablation

Surgical Ablation

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

St. Antonius Hospital Nieuwegein
Hospital Clinic Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Safety and/or adverse events

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

Composite major complications, Serious Adverse Events, Serious Adverse Effects

Full Information

NCT ID

NCT00662701

First Posted

March 25, 2008

Last Updated

November 18, 2015

Sponsor

St. Antonius Hospital

Collaborators

Hospital Clinic of Barcelona, AtriCure, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00662701

Brief Title

Ablation or Surgery for Atrial Fibrillation (AF) Treatment

Acronym

FAST

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

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

St. Antonius Hospital

Collaborators

Hospital Clinic of Barcelona, AtriCure, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

Atrial Fibrillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Catheter Ablation

Intervention Description

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

Intervention Name(s)

Surgical Ablation

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

6 months

Title

Safety and/or adverse events

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Time Frame

6 and 12 Months

Title

Composite major complications, Serious Adverse Events, Serious Adverse Effects

Time Frame

12 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lucas Boersma, MD/PhD

Organizational Affiliation

St. Antonius Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

WimJan van Boven, MD

Organizational Affiliation

St. Antonius Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lluis Mont, MD

Organizational Affiliation

Hospital Clinic of Barcelona

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Castella M, MD

Organizational Affiliation

Hospital Clinic of Barcelona

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Antonius Hospital Nieuwegein

City

Nieuwegein

ZIP/Postal Code

3430

Country

Netherlands

Facility Name

Hospital Clinic Barcelona

City

Barcelona

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

22082673

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.

Results Reference

derived

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Ablation or Surgery for Atrial Fibrillation (AF) Treatment

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