Atrial Fibrillation: Ablation or Surgical Treatment II: FAST II

NCT01336075 | Terminated DMC

• 1 other identifier: FAST II
• Study Type: interventional
• Target: 26
• Locations: 2 countries
• Sites: 3

Brief Summary

The purpose of this study is to compare two invasive treatments of symptomatic paroxysmal atrial fibrillation: Percutaneous radiofrequency catheter ablation and mini invasive thoracoscopic radiofrequency ablation in patients referred for a first time invasive treatment for atrial fibrillation. The hypothesis is, that mini invasive thoracoscopic radiofrequency ablation as a first time invasive treatment is more effective compared to a percutaneous catheter based technique in patients with symptomatic paroxysmal atrial fibrillation refractory or intolerant to at least one antiarrhythmic drug.

Conditions

Paroxysmal Atrial Fibrillation.

Keywords

Percutaneous radiofrequency catheter ablation; Mini invasive thoracoscopic radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• Freedom from atrial fibrillation with or without antiarrhythmic drug.

  Determined by seven days Holter monitoring, ECG, and patient interviews. An episode of atrial fibrillation/flutter/tachycardia is defined as more than 30 seconds of atrial fibrillation observed on Holter monitoring/telemetry or ECG

  12 month follow-up

Secondary Outcomes (4)

• Quality of life

  12 month follow-up

• Procedural complications

  12 month follow-up

• Health economics (cost-effectiveness analysis)

  12 month follow-up

• Reduction in atrial fibrillation burden

  12 month follow-up

Study Arms (2)

Mini invasive thoracoscopic radiofrequency ablation

ACTIVE COMPARATOR

Video-assisted thoracoscopic radiofrequency ablation

Procedure: Mini invasive thoracoscopic radiofrequency ablation

Percutaneous ablation

ACTIVE COMPARATOR

Percutaneous radiofrequency catheter ablation

Procedure: Percutaneous radiofrequency catheter ablation

Interventions

Percutaneous radiofrequency catheter ablation PROCEDURE

Percutaneous radiofrequency catheter ablation around the rights and lefts pulmonary veins, with complete circumferential ablation.

Also known as: Radiofrequency ablation, Catheter ablation, Atrial fibrillation ablation

Percutaneous ablation

Mini invasive thoracoscopic radiofrequency ablation PROCEDURE

Video-assisted thoracoscopic approach for electrical isolation of the pulmonary veins bilaterally and left atrial appendage excision or exclusion.

Also known as: Mini invasive mini maze

Mini invasive thoracoscopic radiofrequency ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recurrent symptomatic paroxysmal atrial fibrillation
• Previously failed one or more antiarrhythmic or beta-blocker medication (treatment \> 30 days) or if any contraindications against treatment with these drug.
• Patient is willing and able to attend the scheduled follow-up visits
• Signed informed consent

You may not qualify if:

• Persistent or permanent atrial fibrillation
• Previously atrial fibrillation ablation procedure
• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
• Severe underlying heart disease (congenital heart disease, significant valvular disease, cardiomyopathy with LVEF \< 35 %, angina pectoris/ ischemic heart disease).
• Severe enlargement of left atrium (\> 45mm)
• Patient with pacemaker
• Failure to obtain informed consent
• Pregnant or breastfeeding women.
• Patient unable to undergo TEE or with documented left atrial thrombus
• Patients with co-morbid conditions who, in the opinion of the investigator, constitute increased risk of general anesthesia or port access, e.g. pleural fibrosis, chronic obstructive pulmonary disease (FEV1 \< 1.5 L/s).
• Known internal carotid artery stenosis (\> 80 %).
• Patients, who are enrolled in another clinical trial
• Life expectancy less than one year
• Previously TIA/stroke

Sponsors & Collaborators

• Aalborg University Hospital: lead
• St. Antonius Hospital: collaborator
• Odense University Hospital: collaborator

Study Sites (3)

Dept of Cardiothoracic surgery and Dept of Cardiology, Aalborg Hospital

Aalborg, 9000, Denmark

Location

Odense Universityhospital

Odense, 5000, Denmark

Location

St. Antonius Hospital

Nieuwegein, 3430, Netherlands

Location

Related Publications (11)

• Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH; ESC Committee for Practice Guidelines. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Europace. 2010 Oct;12(10):1360-420. doi: 10.1093/europace/euq350. No abstract available.

  PMID: 20876603 BACKGROUND

• Yilmaz A, Geuzebroek GS, Van Putte BP, Boersma LV, Sonker U, De Bakker JM, Van Boven WJ. Completely thoracoscopic pulmonary vein isolation with ganglionic plexus ablation and left atrial appendage amputation for treatment of atrial fibrillation. Eur J Cardiothorac Surg. 2010 Sep;38(3):356-60. doi: 10.1016/j.ejcts.2010.01.058. Epub 2010 Mar 12.

  PMID: 20227287 BACKGROUND

• Nair GM, Nery PB, Diwakaramenon S, Healey JS, Connolly SJ, Morillo CA. A systematic review of randomized trials comparing radiofrequency ablation with antiarrhythmic medications in patients with atrial fibrillation. J Cardiovasc Electrophysiol. 2009 Feb;20(2):138-44. doi: 10.1111/j.1540-8167.2008.01285.x. Epub 2008 Sep 3.

  PMID: 18775040 BACKGROUND

• Lafuente-Lafuente C, Mouly S, Longas-Tejero MA, Bergmann JF. Antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD005049. doi: 10.1002/14651858.CD005049.pub2.

  PMID: 17943835 BACKGROUND

• Schilling RJ. Cardioversion of atrial fibrillation: the use of antiarrhythmic drugs. Heart. 2010 Mar;96(5):333-8. doi: 10.1136/hrt.2008.155812. Epub 2009 Nov 11.

  PMID: 19910286 BACKGROUND

• Calkins H, Reynolds MR, Spector P, Sondhi M, Xu Y, Martin A, Williams CJ, Sledge I. Treatment of atrial fibrillation with antiarrhythmic drugs or radiofrequency ablation: two systematic literature reviews and meta-analyses. Circ Arrhythm Electrophysiol. 2009 Aug;2(4):349-61. doi: 10.1161/CIRCEP.108.824789. Epub 2009 Jun 2.

  PMID: 19808490 BACKGROUND

• Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J, Kim YH, Klein G, Natale A, Packer D, Skanes A, Ambrogi F, Biganzoli E. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol. 2010 Feb;3(1):32-8. doi: 10.1161/CIRCEP.109.859116. Epub 2009 Dec 7.

  PMID: 19995881 BACKGROUND

• Cox JL. Cardiac surgery for arrhythmias. J Cardiovasc Electrophysiol. 2004 Feb;15(2):250-62. doi: 10.1046/j.1540-8167.2004.03656.x.

  PMID: 15028063 BACKGROUND

• Gaynor SL, Diodato MD, Prasad SM, Ishii Y, Schuessler RB, Bailey MS, Damiano NR, Bloch JB, Moon MR, Damiano RJ Jr. A prospective, single-center clinical trial of a modified Cox maze procedure with bipolar radiofrequency ablation. J Thorac Cardiovasc Surg. 2004 Oct;128(4):535-42. doi: 10.1016/j.jtcvs.2004.02.044.

  PMID: 15457154 BACKGROUND

• Shen J, Bailey M, Damiano RJ Jr. Surgery for Lone Atrial Fibrillation: Present State-of-the-Art. Innovations (Phila). 2009 Oct;4(5):248-255. doi: 10.1097/IMI.0b013e3181bb370f.

  PMID: 20473355 BACKGROUND

• Sindby JE, Vadmann H, Lundbye-Christensen S, Riahi S, Hjortshoj S, Boersma LVA, Andreasen JJ. Percutaneous versus thoracoscopic ablation of symptomatic paroxysmal atrial fibrillation: a randomised controlled trial - the FAST II study. J Cardiothorac Surg. 2018 Oct 3;13(1):101. doi: 10.1186/s13019-018-0792-8.

  PMID: 30285795 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Henrik Vadmann, MD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

• Sam Riahi, MD, PhD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

• Jan Jesper Andreasen, MD, PhD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

• Søren Hjortshøj, MD, PhD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

• Alaaddin Yilmaz, MD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

• Lucas Boersma, MD, PhD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

• Axel Brandes, MD, FESC

  Odense Universityhospital

  PRINCIPAL INVESTIGATOR

• Peter Pallesen, MD

  Odense Universityhospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D. student

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: April 15, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 3, 2014

Record last verified: 2014-01

Locations

NL (1); DK (2)