Totally Endoscopic Ablation of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— TEA  

Official title:

Totally Endoscopic Ablation of Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940056
• Other study ID #: UHOrebro
• Status: Completed
• Phase: N/A
• First received: July 14, 2009
• Last updated: September 2, 2016
• Start date: November 2009
• Est. completion date: May 2015

Study information

• Verified date: September 2016
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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?

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.

Other known NCT identifiers

• NCT01047228

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

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.

Locations

Country	Name	City	State
Sweden	Örebro University Hospital	Örebro

Sponsors (2)

Lead Sponsor	Collaborator
Region Örebro County	Medtronic

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

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. Erratum in: Heart Rhythm. 2009 Jan;6(1):148. — View Citation

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. Erratum in: Eur Heart J. 2007 Aug;28(16):2046. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: J Thorac Cardiovasc Surg. 2006 Apr;131(4):772. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom of AF 3 - 12 months postoperatively without antiarrhythmic drugs		3-12 months	No
Secondary	Freedom of symptomatic AF episodes 3 - 12 months		3-12 months	No
Secondary	Exercise capacity after 12 months		12 months	No
Secondary	Quality-of-life assessment (SF-36 and SCL) 3, 6 and 12 months		12 months	Yes
Secondary	Atrial function and dimensions after 6 and 12 months		12 months	Yes
Secondary	Freedom of thromboembolic events during the study		12 months	Yes