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CompletedNCT00940056TEAUpdated Sep 5, 2016

Totally Endoscopic Ablation of Atrial Fibrillation

An interventional study of Endoscopic ablation of AF and Rate control in Atrial Fibrillation, sponsored by Region Örebro County. Completed at 1 site in Sweden. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-09-05.

Sponsored by Region Örebro County · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study 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?
Read the detailed description

This is a randomized open controlled single centre study that involves 60 patients (men and women) over the age of 50 years with longstanding persistent AF of more than one year duration and in the absence of other severe cardiopulmonary disease. One of the participating investigators informs the patient, both verbally and in writing, about the study and what participation in the study involves. The patient will be given time to ask questions and to consider study participation and can be enrolled in the study after signing and dating written Informed Consent. Study duration per patient is 12 months.

After inclusion, the patient will be divided into one of two groups, treatment group or control group, according to block wise randomization. The patient will be asked to complete two health related questionnaires SF 36 and SCL and a transthoracic echocardiography will be conducted together with an exercise test.

The patients will thereafter be assessed according to randomisation. Irrespective of group, the patients will be rescheduled for a visit within two months for totally endoscopic ablation and Reveal implantation or just Reveal implantation (control group). All patients will then be assessed during follow-ups after 1, 3, 6 and 12 months.

02

Conditions studied

  • Atrial Fibrillation

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Keywords

  • Atrial fibrillation
  • Ablation
  • Thoracoscopy
  • Atrial function
03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 36 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Region Örebro County is the lead sponsor of 123 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Severe ischemic heart disease or heart valve disease
  2. Thrombus formation in left atrial appendage
  3. Intolerance to warfarin medication
  4. Advanced pulmonary disease, FEV 1 \< 1.5 litre
  5. Left atrial diameter > 60 mm
  6. Body Mass Index (BMI) > 35 kg/m2
  7. Previous pulmonary or heart surgery
  8. Participation in another clinical trial within the last 30 days prior to enrollment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Endoscopic ablation of atrial fibrillation

    Procedure: Endoscopic ablation of AF

  • Active comparator
    Rate control

    Drug: Rate control

Interventions

  • ProcedureEndoscopic ablation of AF

    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.

  • DrugRate control

    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.

06

What researchers measure

Primary outcomes

  1. Freedom of AF 3 - 12 months postoperatively without antiarrhythmic drugs

    Time frame: 3-12 months

Secondary outcomes

  1. Freedom of symptomatic AF episodes 3 - 12 months

    Time frame: 3-12 months

  2. Exercise capacity after 12 months

    Time frame: 12 months

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

    Time frame: 12 months

  4. Atrial function and dimensions after 6 and 12 months

    Time frame: 12 months

  5. Freedom of thromboembolic events during the study

    Time frame: 12 months

07

Study locations

1 site
  • Örebro University Hospital
    Örebro, 70285, Sweden
08

References and documents

Publications

  • 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. Erratum In: Eur Heart J. 2007 Aug;28(16):2046. PubMed 16885201 ↗
  • 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. Erratum In: Heart Rhythm. 2009 Jan;6(1):148. PubMed 17556213 ↗
  • 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. PubMed 18296841 ↗
  • 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. PubMed 17462389 ↗
  • 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. Erratum In: J Thorac Cardiovasc Surg. 2006 Apr;131(4):772. PubMed 16153931 ↗
  • 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. PubMed 17532447 ↗
  • 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. PubMed 27068249 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00940056
Lead sponsor
Region Örebro County
Collaborators
Medtronic
Responsible party
Anders Ahlsson (MD PHD, Region Örebro County) — Principal investigator
First posted
Jul 15, 2009
Start date
Nov 2009
Primary completion
May 2014
Completion
May 2015
Last update
Sep 5, 2016

Study contacts

Anders Ahlsson, MD PhD
principal investigator · Department of Cardiothoracic Surgery
Espen Fengsrud, MD
study chair · Department of Cardiology
Anders Englund, MD PhD
study director · Stockholm Arrhythmia Center
Peter Linde, MD
study chair · Department of Cardiology
Henrik Almroth, MD
study chair · Department of Cardiology
Tommy Andersson, MD
study chair · Department of Cardiology
Hans Tyden, MD PhD
study chair · Department of Cardiothoracic Surgery

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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