Totally Endoscopic Ablation of Atrial Fibrillation

NCT00940056 | Completed DMC

• 1 other identifier: UHOrebro
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective To evaluate the efficiency of totally endoscopic ablation of AF compared to rate control management of AF. Secondary Objectives Does totally endoscopic ablation:

• reduce atrial fibrillation symptoms?
• increase working capacity and improve quality of life?
• improve atrial function?
• reduce the risk for stroke?

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Ablation; Thoracoscopy; Atrial function

Outcome Measures

Primary Outcomes (1)

• Freedom of AF 3 - 12 months postoperatively without antiarrhythmic drugs

  3-12 months

Secondary Outcomes (5)

• Freedom of symptomatic AF episodes 3 - 12 months

  3-12 months

• Exercise capacity after 12 months

  12 months

• Quality-of-life assessment (SF-36 and SCL) 3, 6 and 12 months

  12 months

• Atrial function and dimensions after 6 and 12 months

  12 months

• Freedom of thromboembolic events during the study

  12 months

Study Arms (2)

Endoscopic ablation of atrial fibrillation

EXPERIMENTAL

Procedure: Endoscopic ablation of AF

Rate control

ACTIVE COMPARATOR

Drug: Rate control

Interventions

Endoscopic ablation of AF PROCEDURE

The procedure is conducted in general anaesthesia. The right chest is entered with three working ports . After a complete cycle of ablation creating a box lesion in the left atrium, conduction block is tested. A chest tube is placed through the most caudal port and the port incisions are closed. A Reveal loop recorder is then implanted subcutaneously. The patient is extubated and transferred to postoperative care.

Endoscopic ablation of atrial fibrillation

Rate control DRUG

Anti-arrhythmic protocol The control group is using a rate-control strategy. All patients keep their anti-arrhythmic/beta-blocker/digoxin medication during the entire follow-up. No attempts are made to rhythm-control the patients, unless subjective symptoms make it necessary.

Rate control

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 50 years
• Longstanding persistent AF of \> 1 year duration
• Severe symptoms related to AF
• Have signed and dated Informed Consent.
• Willing and able to comply with the protocol for the duration of the trial.

You may not qualify if:

• Severe ischemic heart disease or heart valve disease
• Thrombus formation in left atrial appendage
• Intolerance to warfarin medication
• Advanced pulmonary disease, FEV 1 \< 1.5 litre
• Left atrial diameter \> 60 mm
• Body Mass Index (BMI) \> 35 kg/m2
• Previous pulmonary or heart surgery
• Participation in another clinical trial within the last 30 days prior to enrollment

Sponsors & Collaborators

• Region Örebro County: lead
• Medtronic: collaborator

Study Sites (1)

Örebro University Hospital

Örebro, 70285, Sweden

Location

Related Publications (7)

• Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S; Task Force on Practice Guidelines, American College of Cardiology/American Heart Association; Committee for Practice Guidelines, European Society of Cardiology; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation-executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients with Atrial Fibrillation). Eur Heart J. 2006 Aug;27(16):1979-2030. doi: 10.1093/eurheartj/ehl176. No abstract available.

  PMID: 16885201 BACKGROUND

• European Heart Rhythm Association (EHRA); European Cardiac Arrhythmia Scoiety (ECAS); American College of Cardiology (ACC); American Heart Association (AHA); Society of Thoracic Surgeons (STS); Calkins H, Brugada J, Packer DL, Cappato R, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, Haines DE, Haissaguerre M, Iesaka Y, Jackman W, Jais P, Kottkamp H, Kuck KH, Lindsay BD, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Natale A, Pappone C, Prystowsky E, Raviele A, Ruskin JN, Shemin RJ. HRS/EHRA/ECAS expert Consensus Statement on catheter and surgical ablation of atrial fibrillation: recommendations for personnel, policy, procedures and follow-up. A report of the Heart Rhythm Society (HRS) Task Force on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2007 Jun;4(6):816-61. doi: 10.1016/j.hrthm.2007.04.005. Epub 2007 Apr 30. No abstract available.

  PMID: 17556213 BACKGROUND

• Matsutani N, Takase B, Ozeki Y, Maehara T, Lee R. Minimally invasive cardiothoracic surgery for atrial fibrillation: a combined Japan-US experience. Circ J. 2008 Mar;72(3):434-6. doi: 10.1253/circj.72.434.

  PMID: 18296841 BACKGROUND

• Sagbas E, Akpinar B, Sanisoglu I, Caynak B, Tamtekin B, Oral K, Onan B. Video-assisted bilateral epicardial pulmonary vein isolation for the treatment of lone atrial fibrillation. Ann Thorac Surg. 2007 May;83(5):1724-30. doi: 10.1016/j.athoracsur.2006.12.009.

  PMID: 17462389 BACKGROUND

• Wolf RK, Schneeberger EW, Osterday R, Miller D, Merrill W, Flege JB Jr, Gillinov AM. Video-assisted bilateral pulmonary vein isolation and left atrial appendage exclusion for atrial fibrillation. J Thorac Cardiovasc Surg. 2005 Sep;130(3):797-802. doi: 10.1016/j.jtcvs.2005.03.041.

  PMID: 16153931 BACKGROUND

• La Meir M, De Roy L, Blommaert D, Buche M. Treatment of lone atrial fibrillation with a right thoracoscopic approach. Ann Thorac Surg. 2007 Jun;83(6):2244-5. doi: 10.1016/j.athoracsur.2006.08.004.

  PMID: 17532447 BACKGROUND

• Fengsrud E, Wickbom A, Almroth H, Englund A, Ahlsson A. Total endoscopic ablation of patients with long-standing persistent atrial fibrillation: a randomized controlled study. Interact Cardiovasc Thorac Surg. 2016 Aug;23(2):292-8. doi: 10.1093/icvts/ivw088. Epub 2016 Apr 10.

  PMID: 27068249 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Heart Rate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Anders Ahlsson, MD PhD

  Department of Cardiothoracic Surgery

  PRINCIPAL INVESTIGATOR

• Espen Fengsrud, MD

  Department of Cardiology

  STUDY CHAIR

• Anders Englund, MD PhD

  Stockholm Arrhythmia Center

  STUDY DIRECTOR

• Peter Linde, MD

  Department of Cardiology

  STUDY CHAIR

• Henrik Almroth, MD

  Department of Cardiology

  STUDY CHAIR

• Tommy Andersson, MD

  Department of Cardiology

  STUDY CHAIR

• Hans Tyden, MD PhD

  Department of Cardiothoracic Surgery

  STUDY CHAIR

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: MD PHD

Study Record Dates

• First Submitted: July 14, 2009
• First Posted: July 15, 2009
• Study Start: November 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2015
• Last Updated: September 5, 2016

Record last verified: 2016-09

Locations

SE (1)