Totally Endoscopic Ablation of Atrial Fibrillation

NCT ID: NCT00940056

Last Updated: 2016-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2015-05-31

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?

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endoscopic ablation of atrial fibrillation

Group Type: EXPERIMENTAL

Endoscopic ablation of AF

Intervention Type: 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.

Rate control

Group Type: ACTIVE_COMPARATOR

Rate control

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Region Örebro County

OTHER

Sponsor Role: lead

Responsible Party

Anders Ahlsson

MD PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anders Ahlsson, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiothoracic Surgery

Espen Fengsrud, MD

Role: STUDY_CHAIR

Department of Cardiology

Anders Englund, MD PhD

Role: STUDY_DIRECTOR

Stockholm Arrhythmia Center

Peter Linde, MD

Role: STUDY_CHAIR

Department of Cardiology

Henrik Almroth, MD

Role: STUDY_CHAIR

Department of Cardiology

Tommy Andersson, MD

Role: STUDY_CHAIR

Department of Cardiology

Hans Tyden, MD PhD

Role: STUDY_CHAIR

Department of Cardiothoracic Surgery

Locations

Örebro University Hospital

Örebro, , Sweden

Countries

Sweden

References

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.

Reference Type: BACKGROUND

PMID: 16885201 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17556213 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18296841 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17462389 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16153931 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17532447 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27068249 (View on PubMed)

Other Identifiers

UHOrebro

Identifier Type: -

Identifier Source: org_study_id

NCT01047228

Identifier Type: -

Identifier Source: nct_alias