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Totally Endoscopic Ablation of Atrial Fibrillation (TEA)

This study is currently recruiting participants.
Verified November 2012 by University Hospital Orebro
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Anders Ahlsson, University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT00940056
First received: July 14, 2009
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

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?

Condition Intervention
Atrial Fibrillation
 Procedure: Endoscopic ablation of AF
Drug: Rate control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Totally Endoscopic Ablation of Atrial Fibrillation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Orebro:

Primary Outcome Measures:
  • Freedom of AF 3 - 12 months postoperatively without antiarrhythmic drugs [ Time Frame: 3-12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Freedom of symptomatic AF episodes 3 - 12 months [ Time Frame: 3-12 months ] [ Designated as safety issue: No ]
  • Exercise capacity after 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality-of-life assessment (SF-36 and SCL) 3, 6 and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Atrial function and dimensions after 6 and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Freedom of thromboembolic events during the study [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: November 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endoscopic ablation of atrial fibrillation Procedure: Endoscopic 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.
Active Comparator: Rate control Drug: Rate 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.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940056

Contacts
Contact: Anders Ahlsson, MD PhD +46196025205 anders.ahlsson@orebroll.se
Contact: Espen Fengsrud, MD +46196025450 espen.fengsrud@orebroll.se

Locations
Sweden
Örebro University Hospital Recruiting
Örebro, Sweden, 70285
Contact: Anders Ahlsson, MD PhD     +46196025205     anders.ahlsson@orebroll.se    
Sponsors and Collaborators
University Hospital Orebro
Medtronic
Investigators
Principal Investigator: Anders Ahlsson, MD PhD Department of Cardiothoracic Surgery
Study Chair: Espen Fengsrud, MD Department of Cardiology
Study Director: Anders Englund, MD PhD Stockholm Arrhythmia Center
Study Chair: 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
  More Information

Publications:
Fuster V, Rydén 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. No abstract available. Erratum in: Eur Heart J. 2007 Aug;28(16):2046.
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. Epub 2007 Apr 30. Review. No abstract available.

Responsible Party: Anders Ahlsson, MD PHD, University Hospital Orebro
ClinicalTrials.gov Identifier: NCT00940056     History of Changes
Obsolete Identifiers: NCT01047228
Other Study ID Numbers: UHOrebro
Study First Received: July 14, 2009
Last Updated: November 16, 2012
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by University Hospital Orebro:
Atrial fibrillation
Ablation
Thoracoscopy
Atrial function

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013