Atrial FibrillationTEANCT00940056
Totally Endoscopic Ablation of Atrial Fibrillation
A study testing Endoscopic ablation of AF in people with Atrial Fibrillation, run by Region Örebro County at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Endoscopic ablation of AF
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2009to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Endoscopic ablation of AF, Rate control
- Keywords
- Atrial fibrillation, Ablation, Thoracoscopy, Atrial function
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ablation of AFProcedure or surgery
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 controlDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic ablation of atrial fibrillation | Experimental | Not described Receives: Procedure: Endoscopic ablation of AF |
| Rate control | Active comparator | Not described Receives: Drug: Rate control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom of AF 3 - 12 months postoperatively without antiarrhythmic drugs
Measured: 3-12 months
Secondary outcomes (5)
Freedom of symptomatic AF episodes 3 - 12 months
Measured: 3-12 months
Exercise capacity after 12 months
Measured: 12 months
Quality-of-life assessment (SF-36 and SCL) 3, 6 and 12 months
Measured: 12 months
Atrial function and dimensions after 6 and 12 months
Measured: 12 months
Freedom of thromboembolic events during the study
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study startNov 2009
- Primary completionMay 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Anders Ahlsson, Region Örebro County
- Investigators
- Anders Ahlsson, MD PhD, Principal investigator, Department of Cardiothoracic SurgeryEspen Fengsrud, MD, Study chair, Department of CardiologyAnders Englund, MD PhD, Study director, Stockholm Arrhythmia CenterPeter Linde, MD, Study chair, Department of CardiologyHenrik Almroth, MD, Study chair, Department of CardiologyTommy Andersson, MD, Study chair, Department of CardiologyHans Tyden, MD PhD, Study chair, Department of Cardiothoracic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940056
- Sponsor's protocol ID
- UHOrebro
- Acronym
- TEA
- Status last verified
- Sep 2016
- First submitted
- 14 Jul 2009
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 16885201European 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.
PubMed 17556213Matsutani 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 18296841Sagbas 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 17462389Wolf 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.
PubMed 16153931La 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 17532447Fengsrud 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Totally Endoscopic Ablation of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00940056
- Acronym / sponsor ID
- TEA / UHOrebro
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Ablation, Thoracoscopy, Atrial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Nov 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 15 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic ablation of atrial fibrillation | Experimental | Procedure: Endoscopic ablation of AF |
| Rate control | Active comparator | Drug: Rate control |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic ablation of AFThe 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. | Procedure or surgery | Endoscopic ablation of atrial fibrillation |
| Rate controlAnti-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. | Drug | Rate control |
Primary outcome
Freedom of AF 3 - 12 months postoperatively without antiarrhythmic drugs
Time frame: 3-12 months
5 secondary outcomes
Freedom of symptomatic AF episodes 3 - 12 months
Time frame: 3-12 months
Exercise capacity after 12 months
Time frame: 12 months
Quality-of-life assessment (SF-36 and SCL) 3, 6 and 12 months
Time frame: 12 months
Atrial function and dimensions after 6 and 12 months
Time frame: 12 months
Freedom of thromboembolic events during the study
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
- Background: PubMed 16885201Fuster 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.
- Background: PubMed 17556213European 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.
- Background: PubMed 18296841Matsutani 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.
- Background: PubMed 17462389Sagbas 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.
- Background: PubMed 16153931Wolf 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.
- Background: PubMed 17532447La 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.
- Derived from this study: PubMed 27068249Fengsrud 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.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ablation of AF in people with Atrial Fibrillation, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom of AF 3 - 12 months postoperatively without antiarrhythmic drugs (time frame: 3-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00940056, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2016.