Paroxysmal Atrial Fibrillation.NCT01336075
Atrial Fibrillation: Ablation or Surgical Treatment II: FAST II
A study testing Percutaneous radiofrequency catheter ablation and Mini invasive thoracoscopic radiofrequency ablation in people with Paroxysmal Atrial Fibrillation., run by Aalborg University Hospital at 3 sites in 2 countries.
Trial summary
The purpose of this study is to compare two invasive treatments of symptomatic paroxysmal atrial fibrillation: Percutaneous radiofrequency catheter ablation and mini invasive thoracoscopic radiofrequency ablation in patients referred for a first time invasive treatment for atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation.
- What is being tested?
- Percutaneous radiofrequency catheter ablation and Mini invasive thoracoscopic radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Apr 2011to Dec 2013
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent symptomatic paroxysmal atrial fibrillation
- Previously failed one or more antiarrhythmic or beta-blocker medication (treatment > 30 days) or if any contraindications against treatment with these drug.
- Patient is willing and able to attend the scheduled follow-up visits
- Signed informed consent
Who cannot join
- Persistent or permanent atrial fibrillation
- Previously atrial fibrillation ablation procedure
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- Severe underlying heart disease (congenital heart disease, significant valvular disease, cardiomyopathy with LVEF < 35 %, angina pectoris/ ischemic heart disease).
- Severe enlargement of left atrium (> 45mm)
- Patient with pacemaker
Show all 14Show fewer
- Failure to obtain informed consent
- Pregnant or breastfeeding women.
- Patient unable to undergo TEE or with documented left atrial thrombus
- Patients with co-morbid conditions who, in the opinion of the investigator, constitute increased risk of general anesthesia or port access, e.g. pleural fibrosis, chronic obstructive pulmonary disease (FEV1 < 1.5 L/s).
- Known internal carotid artery stenosis (> 80 %).
- Patients, who are enrolled in another clinical trial
- Life expectancy less than one year
- Previously TIA/stroke
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Denmark2 sites
Dept of Cardiothoracic surgery and Dept of Cardiology, Aalborg Hospital
Aalborg, 9000
Odense Universityhospital
Odense, 5000
About this study
Official title: Atrial Fibrillation: Ablation or Surgical Treatment II: FAST II A Randomized Study Comparing Non-pharmacologic Therapy in Patients With Drug-refractory Atrial Fibrillation Referred for a First Time Invasive Treatment.
The purpose of this study is to compare two invasive treatments of symptomatic paroxysmal atrial fibrillation: Percutaneous radiofrequency catheter ablation and mini invasive thoracoscopic radiofrequency ablation in patients referred for a first time invasive treatment for atrial fibrillation.
The hypothesis is, that mini invasive thoracoscopic radiofrequency ablation as a first time invasive treatment is more effective compared to a percutaneous catheter based technique in patients with symptomatic paroxysmal atrial fibrillation refractory or intolerant to at least one antiarrhythmic drug.
Read the detailed description
Atrial fibrillation is characterized by disorganized, rapid, and irregular contraction of the atria. Its effects on hemodynamic and thromboembolic events result in significant morbidity, mortality, impaired quality of life, hospitalizations, and health-cost.
It is the most common sustained cardiac arrhythmia. Over six million Europeans suffer from this arrhythmia. The prevalence is estimated to at least double in the next 50 years and is probably underestimated due to asymptomatic atrial fibrillation. The prevalence increases with age and affects men more often.
Atrial fibrillation is treated medically with varying results and there are no definitive long term curative treatments. The main goal aims at reducing symptoms and preventing disabling complications. Treatment normally includes antithrombotic, rhythm, and/or rate management, New non-pharmacological interventions have evolved over the last decades in order to prevent paroxysmal atrial fibrillation and/or reduce symptoms. The main focus of non-pharmacological intervention has been on percutaneous radiofrequency catheter ablation and surgical maze ablation. Both approaches aim at minimizing the impact of "triggers" from the pulmonary veins by electrical isolation of the veins.
Studies comparing antiarrhythmic drug and radiofrequency ablation indicate that radiofrequency ablation has a higher efficacy rate, a lower rate of complications, and in selected patients radiofrequency ablation reduced the risk of atrial fibrillation recurrence after one year by 65 % compared with antiarrhythmic drug. In a recently published paper the success rate after a mean of 1.3 radiofrequency ablation procedures per patient varied from 57.7% to 75.4% with higher success rates in patients with paroxysmal atrial fibrillation as compared to persistent/permanent atrial fibrillation.
European Society of Cardiology recommends that radiofrequency ablation is reserved for patients who remain symptomatic despite optimal therapy and failed at least one antiarrhythmic drug.
Dr. James Cox introduced the Cox-maze surgical operation for atrial fibrillation in 1987, later modified to Cox-maze III also known as the "cut and sew" maze. It is highly successful in restoring sinus rhythm, with 90-96 % being free from atrial fibrillation at a mean follow-up of 5.4 years. Due to its complexity and technical difficulty the procedure has not been widely adopted. Mini invasive procedures for pulmonary vein isolation have been developed and can now be performed either through mini thoracotomies or using totally thoracoscopic approach. These procedures also hold the advantage of left atrial appendage excision or exclusion. The thoracoscopic maze ablation has shown promising results in small studies in patients with recurrence of atrial fibrillation after earlier catheter based radiofrequency ablation, after a mean follow-up of 11 months 84 % of the patients remain in sinus rhythm. However long-term results are still unknown. The procedure still needs to be compared head to head with catheter based radiofrequency ablation before it should be offered as a standard treatment of atrial fibrillation.
The rationale for eliminating atrial fibrillation with radiofrequency ablation include a potential improvement in quality of life, decreased stroke risk, decreased heart failure risk and improved survival.
- Conditions
- Paroxysmal Atrial Fibrillation.
- Being tested
- Percutaneous radiofrequency catheter ablation, Mini invasive thoracoscopic radiofrequency ablation
- Keywords
- Percutaneous radiofrequency catheter ablation, Mini invasive thoracoscopic radiofrequency ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous radiofrequency catheter ablationProcedure or surgery
Also called Radiofrequency ablation, Catheter ablation, Atrial fibrillation ablation
Percutaneous radiofrequency catheter ablation around the rights and lefts pulmonary veins, with complete circumferential ablation.
Mini invasive thoracoscopic radiofrequency ablationProcedure or surgery
Also called Mini invasive mini maze
Video-assisted thoracoscopic approach for electrical isolation of the pulmonary veins bilaterally and left atrial appendage excision or exclusion.
| Study group | Role | What they receive |
|---|---|---|
| Mini invasive thoracoscopic radiofrequency ablation | Active comparator | Video-assisted thoracoscopic radiofrequency ablation Receives: Procedure: Mini invasive thoracoscopic radiofrequency ablation |
| Percutaneous ablation | Active comparator | Percutaneous radiofrequency catheter ablation Receives: Procedure: Percutaneous radiofrequency catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial fibrillation with or without antiarrhythmic drug.
Determined by seven days Holter monitoring, ECG, and patient interviews. An episode of atrial fibrillation/flutter/tachycardia is defined as more than 30 seconds of atrial fibrillation observed on Holter monitoring/telemetry or ECG
Measured: 12 month follow-up
Secondary outcomes (4)
Quality of life
Comparison of quality of life before ablation and at follow-up, by 4 different quality of life questionnaires AFEQT, AF-QoL-18, GAD-7 and PHQ-9.
Measured: 12 month follow-up
Procedural complications
Thromboembolic events (TIA,Stroke), Mortality, Tamponade, need for thoracotomy, bleeding, infection, esophageal fistula, embolic events, death , pneumothorax and hemothorax.
Measured: 12 month follow-up
Health economics (cost-effectiveness analysis)
Measured: 12 month follow-up
Reduction in atrial fibrillation burden
Measured: 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Too few participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal Atrial Fibrillation.Studies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Antonius Hospital, Odense University Hospital
- Responsible party
- Principal investigator, Henrik Vadmann, MD, Ph.d student., Aalborg University Hospital
- Investigators
- Henrik Vadmann, MD, Principal investigator, Aalborg University HospitalSam Riahi, MD, PhD, Principal investigator, Aalborg University HospitalJan Jesper Andreasen, MD, PhD, Principal investigator, Aalborg University HospitalSøren Hjortshøj, MD, PhD, Principal investigator, Aalborg University HospitalAlaaddin Yilmaz, MD, Principal investigator, St. Antonius HospitalLucas Boersma, MD, PhD, Principal investigator, St. Antonius HospitalAxel Brandes, MD, FESC, Principal investigator, Odense UniversityhospitalPeter Pallesen, MD, Principal investigator, Odense Universityhospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336075
- Sponsor's protocol ID
- FAST II
- Status last verified
- Jan 2014
- First submitted
- 13 Apr 2011
- Last updated
- 3 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH; ESC Committee for Practice Guidelines. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Europace. 2010 Oct;12(10):1360-420. doi: 10.1093/europace/euq350. No abstract available.
PubMed 20876603Yilmaz A, Geuzebroek GS, Van Putte BP, Boersma LV, Sonker U, De Bakker JM, Van Boven WJ. Completely thoracoscopic pulmonary vein isolation with ganglionic plexus ablation and left atrial appendage amputation for treatment of atrial fibrillation. Eur J Cardiothorac Surg. 2010 Sep;38(3):356-60. doi: 10.1016/j.ejcts.2010.01.058. Epub 2010 Mar 12.
PubMed 20227287Nair GM, Nery PB, Diwakaramenon S, Healey JS, Connolly SJ, Morillo CA. A systematic review of randomized trials comparing radiofrequency ablation with antiarrhythmic medications in patients with atrial fibrillation. J Cardiovasc Electrophysiol. 2009 Feb;20(2):138-44. doi: 10.1111/j.1540-8167.2008.01285.x. Epub 2008 Sep 3.
PubMed 18775040Lafuente-Lafuente C, Mouly S, Longas-Tejero MA, Bergmann JF. Antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD005049. doi: 10.1002/14651858.CD005049.pub2.
PubMed 17943835Schilling RJ. Cardioversion of atrial fibrillation: the use of antiarrhythmic drugs. Heart. 2010 Mar;96(5):333-8. doi: 10.1136/hrt.2008.155812. Epub 2009 Nov 11.
PubMed 19910286Calkins H, Reynolds MR, Spector P, Sondhi M, Xu Y, Martin A, Williams CJ, Sledge I. Treatment of atrial fibrillation with antiarrhythmic drugs or radiofrequency ablation: two systematic literature reviews and meta-analyses. Circ Arrhythm Electrophysiol. 2009 Aug;2(4):349-61. doi: 10.1161/CIRCEP.108.824789. Epub 2009 Jun 2.
PubMed 19808490Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J, Kim YH, Klein G, Natale A, Packer D, Skanes A, Ambrogi F, Biganzoli E. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol. 2010 Feb;3(1):32-8. doi: 10.1161/CIRCEP.109.859116. Epub 2009 Dec 7.
PubMed 19995881Cox JL. Cardiac surgery for arrhythmias. J Cardiovasc Electrophysiol. 2004 Feb;15(2):250-62. doi: 10.1046/j.1540-8167.2004.03656.x.
PubMed 15028063Gaynor SL, Diodato MD, Prasad SM, Ishii Y, Schuessler RB, Bailey MS, Damiano NR, Bloch JB, Moon MR, Damiano RJ Jr. A prospective, single-center clinical trial of a modified Cox maze procedure with bipolar radiofrequency ablation. J Thorac Cardiovasc Surg. 2004 Oct;128(4):535-42. doi: 10.1016/j.jtcvs.2004.02.044.
PubMed 15457154Shen J, Bailey M, Damiano RJ Jr. Surgery for Lone Atrial Fibrillation: Present State-of-the-Art. Innovations (Phila). 2009 Oct;4(5):248-255. doi: 10.1097/IMI.0b013e3181bb370f.
PubMed 20473355Sindby JE, Vadmann H, Lundbye-Christensen S, Riahi S, Hjortshoj S, Boersma LVA, Andreasen JJ. Percutaneous versus thoracoscopic ablation of symptomatic paroxysmal atrial fibrillation: a randomised controlled trial - the FAST II study. J Cardiothorac Surg. 2018 Oct 3;13(1):101. doi: 10.1186/s13019-018-0792-8.
PubMed 30285795
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation: Ablation or Surgical Treatment II: FAST II A Randomized Study Comparing Non-pharmacologic Therapy in Patients With Drug-refractory Atrial Fibrillation Referred for a First Time Invasive Treatment.
- ClinicalTrials.gov ID
- NCT01336075
- Acronym / sponsor ID
- FAST II
- Conditions
- Paroxysmal Atrial Fibrillation.
- Keywords
- Percutaneous radiofrequency catheter ablation, Mini invasive thoracoscopic radiofrequency ablation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too few participants
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- St. Antonius Hospital, Odense University Hospital
- Study start
- Apr 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Apr 2011 (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.
The purpose of this study is to compare two invasive treatments of symptomatic paroxysmal atrial fibrillation: Percutaneous radiofrequency catheter ablation and mini invasive thoracoscopic radiofrequency ablation in patients referred for a first time invasive treatment for atrial fibrillation.
The hypothesis is, that mini invasive thoracoscopic radiofrequency ablation as a first time invasive treatment is more effective compared to a percutaneous catheter based technique in patients with symptomatic paroxysmal atrial fibrillation refractory or intolerant to at least one antiarrhythmic drug.
Detailed description
Atrial fibrillation is characterized by disorganized, rapid, and irregular contraction of the atria. Its effects on hemodynamic and thromboembolic events result in significant morbidity, mortality, impaired quality of life, hospitalizations, and health-cost.
It is the most common sustained cardiac arrhythmia. Over six million Europeans suffer from this arrhythmia. The prevalence is estimated to at least double in the next 50 years and is probably underestimated due to asymptomatic atrial fibrillation. The prevalence increases with age and affects men more often.
Atrial fibrillation is treated medically with varying results and there are no definitive long term curative treatments. The main goal aims at reducing symptoms and preventing disabling complications. Treatment normally includes antithrombotic, rhythm, and/or rate management, New non-pharmacological interventions have evolved over the last decades in order to prevent paroxysmal atrial fibrillation and/or reduce symptoms. The main focus of non-pharmacological intervention has been on percutaneous radiofrequency catheter ablation and surgical maze ablation. Both approaches aim at minimizing the impact of "triggers" from the pulmonary veins by electrical isolation of the veins.
Studies comparing antiarrhythmic drug and radiofrequency ablation indicate that radiofrequency ablation has a higher efficacy rate, a lower rate of complications, and in selected patients radiofrequency ablation reduced the risk of atrial fibrillation recurrence after one year by 65 % compared with antiarrhythmic drug. In a recently published paper the success rate after a mean of 1.3 radiofrequency ablation procedures per patient varied from 57.7% to 75.4% with higher success rates in patients with paroxysmal atrial fibrillation as compared to persistent/permanent atrial fibrillation.
European Society of Cardiology recommends that radiofrequency ablation is reserved for patients who remain symptomatic despite optimal therapy and failed at least one antiarrhythmic drug.
Dr. James Cox introduced the Cox-maze surgical operation for atrial fibrillation in 1987, later modified to Cox-maze III also known as the "cut and sew" maze. It is highly successful in restoring sinus rhythm, with 90-96 % being free from atrial fibrillation at a mean follow-up of 5.4 years. Due to its complexity and technical difficulty the procedure has not been widely adopted. Mini invasive procedures for pulmonary vein isolation have been developed and can now be performed either through mini thoracotomies or using totally thoracoscopic approach. These procedures also hold the advantage of left atrial appendage excision or exclusion. The thoracoscopic maze ablation has shown promising results in small studies in patients with recurrence of atrial fibrillation after earlier catheter based radiofrequency ablation, after a mean follow-up of 11 months 84 % of the patients remain in sinus rhythm. However long-term results are still unknown. The procedure still needs to be compared head to head with catheter based radiofrequency ablation before it should be offered as a standard treatment of atrial fibrillation.
The rationale for eliminating atrial fibrillation with radiofrequency ablation include a potential improvement in quality of life, decreased stroke risk, decreased heart failure risk and improved survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini invasive thoracoscopic radiofrequency ablation | Active comparator | Procedure: Mini invasive thoracoscopic radiofrequency ablationVideo-assisted thoracoscopic radiofrequency ablation |
| Percutaneous ablation | Active comparator | Procedure: Percutaneous radiofrequency catheter ablationPercutaneous radiofrequency catheter ablation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recurrent symptomatic paroxysmal atrial fibrillation
- Previously failed one or more antiarrhythmic or beta-blocker medication (treatment > 30 days) or if any contraindications against treatment with these drug.
- Patient is willing and able to attend the scheduled follow-up visits
- Signed informed consent
Key exclusion criteria (14 listed)
- Persistent or permanent atrial fibrillation
- Previously atrial fibrillation ablation procedure
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- Severe underlying heart disease (congenital heart disease, significant valvular disease, cardiomyopathy with LVEF < 35 %, angina pectoris/ ischemic heart disease).
- Severe enlargement of left atrium (> 45mm)
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 |
|---|---|---|
| Percutaneous radiofrequency catheter ablationAlso: Radiofrequency ablation, Catheter ablation, Atrial fibrillation ablationPercutaneous radiofrequency catheter ablation around the rights and lefts pulmonary veins, with complete circumferential ablation. | Procedure or surgery | Percutaneous ablation |
| Mini invasive thoracoscopic radiofrequency ablationAlso: Mini invasive mini mazeVideo-assisted thoracoscopic approach for electrical isolation of the pulmonary veins bilaterally and left atrial appendage excision or exclusion. | Procedure or surgery | Mini invasive thoracoscopic radiofrequency ablation |
Primary outcome
Freedom from atrial fibrillation with or without antiarrhythmic drug.
Time frame: 12 month follow-up
Determined by seven days Holter monitoring, ECG, and patient interviews. An episode of atrial fibrillation/flutter/tachycardia is defined as more than 30 seconds of atrial fibrillation observed on Holter monitoring/telemetry or ECG
4 secondary outcomes
Quality of life
Time frame: 12 month follow-up
Procedural complications
Time frame: 12 month follow-up
Health economics (cost-effectiveness analysis)
Time frame: 12 month follow-up
Reduction in atrial fibrillation burden
Time frame: 12 month follow-up
Results and safety
The study was stopped early (reason given: Too few participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2014.
- Background: PubMed 20876603Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH; ESC Committee for Practice Guidelines. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Europace. 2010 Oct;12(10):1360-420. doi: 10.1093/europace/euq350. No abstract available.
- Background: PubMed 20227287Yilmaz A, Geuzebroek GS, Van Putte BP, Boersma LV, Sonker U, De Bakker JM, Van Boven WJ. Completely thoracoscopic pulmonary vein isolation with ganglionic plexus ablation and left atrial appendage amputation for treatment of atrial fibrillation. Eur J Cardiothorac Surg. 2010 Sep;38(3):356-60. doi: 10.1016/j.ejcts.2010.01.058. Epub 2010 Mar 12.
- Background: PubMed 18775040Nair GM, Nery PB, Diwakaramenon S, Healey JS, Connolly SJ, Morillo CA. A systematic review of randomized trials comparing radiofrequency ablation with antiarrhythmic medications in patients with atrial fibrillation. J Cardiovasc Electrophysiol. 2009 Feb;20(2):138-44. doi: 10.1111/j.1540-8167.2008.01285.x. Epub 2008 Sep 3.
- Background: PubMed 17943835Lafuente-Lafuente C, Mouly S, Longas-Tejero MA, Bergmann JF. Antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD005049. doi: 10.1002/14651858.CD005049.pub2.
- Background: PubMed 19910286Schilling RJ. Cardioversion of atrial fibrillation: the use of antiarrhythmic drugs. Heart. 2010 Mar;96(5):333-8. doi: 10.1136/hrt.2008.155812. Epub 2009 Nov 11.
- Background: PubMed 19808490Calkins H, Reynolds MR, Spector P, Sondhi M, Xu Y, Martin A, Williams CJ, Sledge I. Treatment of atrial fibrillation with antiarrhythmic drugs or radiofrequency ablation: two systematic literature reviews and meta-analyses. Circ Arrhythm Electrophysiol. 2009 Aug;2(4):349-61. doi: 10.1161/CIRCEP.108.824789. Epub 2009 Jun 2.
- Background: PubMed 19995881Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J, Kim YH, Klein G, Natale A, Packer D, Skanes A, Ambrogi F, Biganzoli E. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol. 2010 Feb;3(1):32-8. doi: 10.1161/CIRCEP.109.859116. Epub 2009 Dec 7.
- Background: PubMed 15028063Cox JL. Cardiac surgery for arrhythmias. J Cardiovasc Electrophysiol. 2004 Feb;15(2):250-62. doi: 10.1046/j.1540-8167.2004.03656.x.
- Background: PubMed 15457154Gaynor SL, Diodato MD, Prasad SM, Ishii Y, Schuessler RB, Bailey MS, Damiano NR, Bloch JB, Moon MR, Damiano RJ Jr. A prospective, single-center clinical trial of a modified Cox maze procedure with bipolar radiofrequency ablation. J Thorac Cardiovasc Surg. 2004 Oct;128(4):535-42. doi: 10.1016/j.jtcvs.2004.02.044.
- Background: PubMed 20473355Shen J, Bailey M, Damiano RJ Jr. Surgery for Lone Atrial Fibrillation: Present State-of-the-Art. Innovations (Phila). 2009 Oct;4(5):248-255. doi: 10.1097/IMI.0b013e3181bb370f.
- Derived from this study: PubMed 30285795Sindby JE, Vadmann H, Lundbye-Christensen S, Riahi S, Hjortshoj S, Boersma LVA, Andreasen JJ. Percutaneous versus thoracoscopic ablation of symptomatic paroxysmal atrial fibrillation: a randomised controlled trial - the FAST II study. J Cardiothorac Surg. 2018 Oct 3;13(1):101. doi: 10.1186/s13019-018-0792-8.
Related trials for Paroxysmal Atrial Fibrillation.
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
RecruitingObservational study
A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
Atrial Fibrillation
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Not yet recruitingObservational study
Catheter Ablation Using a Novel Navigation and Imaging System
Paroxysmal Atrial Fibrillation
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.
Henrik Vadmann, MD principal investigator
Aalborg University Hospital
Sam Riahi, MD, PhD principal investigator
Aalborg University Hospital
Jan Jesper Andreasen, MD, PhD principal investigator
Aalborg University Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous radiofrequency catheter ablation and Mini invasive thoracoscopic radiofrequency ablation in people with Paroxysmal Atrial Fibrillation., run by Aalborg University Hospital at 3 sites in 2 countries.
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 4 inclusion and 14 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: stopped early, as of the sponsor's last update on 3 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Netherlands. 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 was stopped early (reason given: Too few participants). Results are not available in the source record.
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 from atrial fibrillation with or without antiarrhythmic drug. (time frame: 12 month follow-up). 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 NCT01336075, which also lists 11 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 3 Jan 2014.