Atrial FibrillationPhase 4AFACTNCT01091389
Atrial Fibrillation Ablation and Autonomic Modulation Via Thorascopic Surgery
A Phase 4 study testing Totally Thoracoscopic PV isolation in people with Atrial Fibrillation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
This study aims at investigating the role of autonomic modulation of AF. Therefore, totally thoracoscopic PV isolation with additional ablation of ganglionated plexi (GP) will be studied against PV isolation alone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Totally Thoracoscopic PV isolation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2010to Jan 2017
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age is between 18 and 80 years
- AF is symptomatic, paroxysmal or persistent (hence not long standing persistent)
- In case of persistent AF, successful cardioversion within the last 12 months (cardioversion will be considered failed if AF recurs within 48 hours)
- AF was documented on ECG, Holter or pacemaker electrogram at least once in the 6 months preceding presentation
- At least one class I or III antiarrhythmic drug in standard dosage has failed or is not tolerated
- Legally competent and willing and able to sign informed consent
- Willing and able to adhere to the follow up visit protocol
- Life expectancy of ≥2 years
Who cannot join
- Prior catheter ablation for AF within the preceding 4 months
- Refusal to take antiarrhythmic medication
- Myocardial infarction (defined as CKMB> twice upper limit of normal) within the preceding 2 months
- NYHA class IV/IV heart failure symptoms, or class II-III with a recent decompensation requiring hospitalization or left ventricular ejection fraction<35% (unless related to or aggravated by AF).
- Cerebrovascular accident (defined as any sudden neurological deficit lasting longer than 24 hours, with or without pathological changes on the CT cerebrum) with the preceding 6 months
- Known and documented carotid stenosis>80%
Show all 15Show fewer
- Planned cardiac surgery for other purposes than AF (alone)
- Evidence of active infection (as evidenced by increased white blood cell count, elevated CRP level or fever >38,5 °C)
- Unable to undergo TEE
- Pregnancy or of childbearing potential without adequate contraception
- Requirement of antiarrhythmic medication for ventricular arrhythmias
- Presence of intracardiac mass or thrombus (Discovery of any thrombus or intracardiac mass after signing of the informed consent will result in withdrawal of the patient from the study)
- Co-morbid condition that possesses undue risk of general anesthesia or port access cardiac surgery (in the opinion of the investigator)
- History of previous radiation therapy on the thorax
- Circumstances that prevent follow-up (no permanent home or address, transient, etc.)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam, 1100 DD
About this study
Official title: A Randomized Single Center Study to Prospectively Investigate the Effect of Ablation of the Autonomic Ganglia in Addition to Minimally Invasive Surgical Isolation of Pulmonary Veins in Patients With Atrial Fibrillation
This study aims at investigating the role of autonomic modulation of AF. Therefore, totally thoracoscopic PV isolation with additional ablation of ganglionated plexi (GP) will be studied against PV isolation alone. Two groups of patients (paroxysmal AF with or without structural heart disease and persistent AF with or without heart disease) of 110 patients each will be studied.
Read the detailed description
Atrial fibrillation (AF) is the most common chronic arrhythmia in man. Its treatment consists of control of ventricular rate or attempts to restore sinus rhythm. For symptomatic patients who fail on anti arrhythmic drugs, isolation of the pulmonary veins (PV), with additional linear left atrial lesions when appropriate, can cure AF. At least in some, but probably in many patients, the autonomous nervous system plays a pivotal role in the initiation and perpetuation of AF. The autonomic ganglia, or ganglionated plexi (GP) are located within the epicardial fat pads of the left atrium. This study aims at investigating the additional value of ablation of those GPs in addition to totally thoracoscopic PV isolation.
Objective of the study:
This study aims at investigating the role of autonomic modulation of AF. Therefore, totally thoracoscopic PV isolation with additional ablation of ganglionated plexi (GP) will be studied against PV isolation alone. Two groups of patients (paroxysmal AF with or without structural heart disease and persistent AF with or without heart disease) of 110 patients each will be studied.
Study design:
This is a single center, randomized single blinded study
Study population:
Any patient with an indication for non-pharmacological treatment of symptomatic paroxysmal or persistent AF can enter the study. An indication for non-pharmacological treatment exists when patients are symptomatic and have failed on at least one anti-arrhythmic drug. Symptoms of AF include, but are not limited to palpitations, reduced exercise capacity, exertional dyspnea, and fatigue. Failure of anti-arrhythmic therapy is defined as 1) recurrence of AF despite the use of an anti-arrhythmic drug in a clinical efficacious dosing or 2) adverse effects of medication that is not acceptable to the patient.
Intervention (if applicable):
In patients randomized to additional GP ablation, the following procedures will be carried out during the totally thoracoscopic procedure in addition to the PV isolation (and extended lesion set when appropriate): The left atrial autonomic GPs are localized within the epicardial fat pads and subsequently ablated with radiofrequency current delivered through an ablation probe (AtriCure Isolator™ Transpolar™ pen).
- Conditions
- Atrial Fibrillation
- Being tested
- Totally Thoracoscopic PV isolation
- Keywords
- Atrial Fibrillation, Totally Thoracoscopic PV isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Totally Thoracoscopic PV isolationProcedure or surgery
Also called Mini-Maze, VATS-PVI
Surgery is performed through three ports bilaterally in the intercostal spaces. PVI is performed with a bipolar radiofrequency clamp and confirmed with a custom made multi-electrode probe with closely spaced (1mm) electrode terminals. Additional left atrial ablation lines are created and conduction block is verified in patients with persistent and permanent AF.
| Study group | Role | What they receive |
|---|---|---|
| GP ablation | Experimental | Thoracoscopic PV isolation with GP ablation Receives: Procedure: Totally Thoracoscopic PV isolation |
| No GP ablation | Experimental | Thoracoscopic PV isolation with no GP ablation Receives: Procedure: Totally Thoracoscopic PV isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study is freedom of AF after one year after the procedure without the use of antiarrhythmic drugs.
The primary endpoint of the study is freedom of AF after one year after the procedure without the use of antiarrhythmic drugs. Freedom of AF is defined as the absence of documentation of AF on serial Holter recordings during follow up and on ECGs recorded outside the scope of the study. One single episode of <30 minutes is allowed. Patients complaints about palpitations without the documentation of AF is allowed.
Measured: One year
Secondary outcomes (2)
Freedom of AF after two years after the procedure without the use of any antiarrhythmic drug
Freedom of AF after two years after the procedure without the use of any antiarrhythmic drug. Definition of freedom of AF as above.
Measured: Two Years
Quality of life
Improvement of functional status as measured by the RAND 36 quality of life questionnaires
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startMar 2010
- Primary completion23 Feb 2015
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Heart Foundation
- Responsible party
- Principal investigator, J.R. de Groot, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- J.R. De Groot, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091389
- Sponsor's protocol ID
- NL30199.018.10
- Acronym
- AFACT
- Status last verified
- Apr 2017
- First submitted
- 23 Mar 2010
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Driessen AHG, Berger WR, Krul SPJ, van den Berg NWE, Neefs J, Piersma FR, Chan Pin Yin DRPP, de Jong JSSG, van Boven WP, de Groot JR. Ganglion Plexus Ablation in Advanced Atrial Fibrillation: The AFACT Study. J Am Coll Cardiol. 2016 Sep 13;68(11):1155-1165. doi: 10.1016/j.jacc.2016.06.036.
PubMed 27609676Dong Z, Terpstra MM, Neefs J, van den Berg NWE, Piersma FR, Krul SPJ, Berger WR, van Boven WP, de Jong JSSG, Coronel R, de Groot JR, Driessen AHG. Impact of Ganglionated Plexus Ablation on Early Recurrence After Thoracoscopic Atrial Fibrillation Ablation: A Post Hoc Analysis of the AFACT Study. J Cardiovasc Electrophysiol. 2026 Oct 6. doi: 10.1111/jce.70517. Online ahead of print.
PubMed 42836743Dong Z, Terpstra MM, da Silva da Freitas AF, Jongejan A, Driessen AHG, van Boven WP, de Jong JSSG, Coronel R, de Groot JR. Clinical, histologic, and molecular associations of early and late recurrence after thoracoscopic ablation for atrial fibrillation. Heart Rhythm. 2026 Jun 1:S1547-5271(26)02412-4. doi: 10.1016/j.hrthm.2026.05.045. Online ahead of print.
PubMed 42229869Wesselink R, Neefs J, van den Berg NWE, Meulendijks ER, Terpstra MM, Kawasaki M, Nariswari FA, Piersma FR, van Boven WJP, Driessen AHG, de Groot JR. Does left atrial epicardial conduction time reflect atrial fibrosis and the risk of atrial fibrillation recurrence after thoracoscopic ablation? Post hoc analysis of the AFACT trial. BMJ Open. 2022 Mar 9;12(3):e056829. doi: 10.1136/bmjopen-2021-056829.
PubMed 35264365Reyat JS, Chua W, Cardoso VR, Witten A, Kastner PM, Kabir SN, Sinner MF, Wesselink R, Holmes AP, Pavlovic D, Stoll M, Kaab S, Gkoutos GV, de Groot JR, Kirchhof P, Fabritz L. Reduced left atrial cardiomyocyte PITX2 and elevated circulating BMP10 predict atrial fibrillation after ablation. JCI Insight. 2020 Aug 20;5(16):e139179. doi: 10.1172/jci.insight.139179.
PubMed 32814717Berger WR, Neefs J, van den Berg NWE, Krul SPJ, van Praag EM, Piersma FR, de Jong JSSG, van Boven WP, Driessen AHG, de Groot JR. Additional Ganglion Plexus Ablation During Thoracoscopic Surgical Ablation of Advanced Atrial Fibrillation: Intermediate Follow-Up of the AFACT Study. JACC Clin Electrophysiol. 2019 Mar;5(3):343-353. doi: 10.1016/j.jacep.2018.10.008. Epub 2018 Nov 28.
PubMed 30898238
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Single Center Study to Prospectively Investigate the Effect of Ablation of the Autonomic Ganglia in Addition to Minimally Invasive Surgical Isolation of Pulmonary Veins in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01091389
- Acronym / sponsor ID
- AFACT / NL30199.018.10
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Totally Thoracoscopic PV isolation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Netherlands Heart Foundation
- Study start
- Mar 2010
- Primary completion
- 23 Feb 2015 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 24 Mar 2010 (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.
This study aims at investigating the role of autonomic modulation of AF. Therefore, totally thoracoscopic PV isolation with additional ablation of ganglionated plexi (GP) will be studied against PV isolation alone. Two groups of patients (paroxysmal AF with or without structural heart disease and persistent AF with or without heart disease) of 110 patients each will be studied.
Detailed description
Atrial fibrillation (AF) is the most common chronic arrhythmia in man. Its treatment consists of control of ventricular rate or attempts to restore sinus rhythm. For symptomatic patients who fail on anti arrhythmic drugs, isolation of the pulmonary veins (PV), with additional linear left atrial lesions when appropriate, can cure AF. At least in some, but probably in many patients, the autonomous nervous system plays a pivotal role in the initiation and perpetuation of AF. The autonomic ganglia, or ganglionated plexi (GP) are located within the epicardial fat pads of the left atrium. This study aims at investigating the additional value of ablation of those GPs in addition to totally thoracoscopic PV isolation.
Objective of the study:
This study aims at investigating the role of autonomic modulation of AF. Therefore, totally thoracoscopic PV isolation with additional ablation of ganglionated plexi (GP) will be studied against PV isolation alone. Two groups of patients (paroxysmal AF with or without structural heart disease and persistent AF with or without heart disease) of 110 patients each will be studied.
Study design:
This is a single center, randomized single blinded study
Study population:
Any patient with an indication for non-pharmacological treatment of symptomatic paroxysmal or persistent AF can enter the study. An indication for non-pharmacological treatment exists when patients are symptomatic and have failed on at least one anti-arrhythmic drug. Symptoms of AF include, but are not limited to palpitations, reduced exercise capacity, exertional dyspnea, and fatigue. Failure of anti-arrhythmic therapy is defined as 1) recurrence of AF despite the use of an anti-arrhythmic drug in a clinical efficacious dosing or 2) adverse effects of medication that is not acceptable to the patient.
Intervention (if applicable):
In patients randomized to additional GP ablation, the following procedures will be carried out during the totally thoracoscopic procedure in addition to the PV isolation (and extended lesion set when appropriate): The left atrial autonomic GPs are localized within the epicardial fat pads and subsequently ablated with radiofrequency current delivered through an ablation probe (AtriCure Isolator™ Transpolar™ pen).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GP ablation | Experimental | Procedure: Totally Thoracoscopic PV isolationThoracoscopic PV isolation with GP ablation |
| No GP ablation | Experimental | Procedure: Totally Thoracoscopic PV isolationThoracoscopic PV isolation with no GP ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age is between 18 and 80 years
- AF is symptomatic, paroxysmal or persistent (hence not long standing persistent)
- In case of persistent AF, successful cardioversion within the last 12 months (cardioversion will be considered failed if AF recurs within 48 hours)
- AF was documented on ECG, Holter or pacemaker electrogram at least once in the 6 months preceding presentation
- At least one class I or III antiarrhythmic drug in standard dosage has failed or is not tolerated
Key exclusion criteria (15 listed)
- Prior catheter ablation for AF within the preceding 4 months
- Refusal to take antiarrhythmic medication
- Myocardial infarction (defined as CKMB> twice upper limit of normal) within the preceding 2 months
- NYHA class IV/IV heart failure symptoms, or class II-III with a recent decompensation requiring hospitalization or left ventricular ejection fraction<35% (unless related to or aggravated by AF).
- Cerebrovascular accident (defined as any sudden neurological deficit lasting longer than 24 hours, with or without pathological changes on the CT cerebrum) with the preceding 6 months
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 |
|---|---|---|
| Totally Thoracoscopic PV isolationAlso: Mini-Maze, VATS-PVISurgery is performed through three ports bilaterally in the intercostal spaces. PVI is performed with a bipolar radiofrequency clamp and confirmed with a custom made multi-electrode probe with closely spaced (1mm) electrode terminals. Additional left atrial ablation lines are created and conduction block is verified in patients with persistent and permanent AF. | Procedure or surgery | GP ablation, No GP ablation |
Primary outcome
The primary endpoint of the study is freedom of AF after one year after the procedure without the use of antiarrhythmic drugs.
Time frame: One year
The primary endpoint of the study is freedom of AF after one year after the procedure without the use of antiarrhythmic drugs. Freedom of AF is defined as the absence of documentation of AF on serial Holter recordings during follow up and on ECGs recorded outside the scope of the study. One single episode of <30 minutes is allowed. Patients complaints about palpitations without the documentation of AF is allowed.
2 secondary outcomes
Freedom of AF after two years after the procedure without the use of any antiarrhythmic drug
Time frame: Two Years
Quality of life
Time frame: One Year
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 25 Apr 2017.
- Results publication: PubMed 27609676Driessen AHG, Berger WR, Krul SPJ, van den Berg NWE, Neefs J, Piersma FR, Chan Pin Yin DRPP, de Jong JSSG, van Boven WP, de Groot JR. Ganglion Plexus Ablation in Advanced Atrial Fibrillation: The AFACT Study. J Am Coll Cardiol. 2016 Sep 13;68(11):1155-1165. doi: 10.1016/j.jacc.2016.06.036.
- Derived from this study: PubMed 42836743Dong Z, Terpstra MM, Neefs J, van den Berg NWE, Piersma FR, Krul SPJ, Berger WR, van Boven WP, de Jong JSSG, Coronel R, de Groot JR, Driessen AHG. Impact of Ganglionated Plexus Ablation on Early Recurrence After Thoracoscopic Atrial Fibrillation Ablation: A Post Hoc Analysis of the AFACT Study. J Cardiovasc Electrophysiol. 2026 Oct 6. doi: 10.1111/jce.70517. Online ahead of print.
- Derived from this study: PubMed 42229869Dong Z, Terpstra MM, da Silva da Freitas AF, Jongejan A, Driessen AHG, van Boven WP, de Jong JSSG, Coronel R, de Groot JR. Clinical, histologic, and molecular associations of early and late recurrence after thoracoscopic ablation for atrial fibrillation. Heart Rhythm. 2026 Jun 1:S1547-5271(26)02412-4. doi: 10.1016/j.hrthm.2026.05.045. Online ahead of print.
- Derived from this study: PubMed 35264365Wesselink R, Neefs J, van den Berg NWE, Meulendijks ER, Terpstra MM, Kawasaki M, Nariswari FA, Piersma FR, van Boven WJP, Driessen AHG, de Groot JR. Does left atrial epicardial conduction time reflect atrial fibrosis and the risk of atrial fibrillation recurrence after thoracoscopic ablation? Post hoc analysis of the AFACT trial. BMJ Open. 2022 Mar 9;12(3):e056829. doi: 10.1136/bmjopen-2021-056829.
- Derived from this study: PubMed 32814717Reyat JS, Chua W, Cardoso VR, Witten A, Kastner PM, Kabir SN, Sinner MF, Wesselink R, Holmes AP, Pavlovic D, Stoll M, Kaab S, Gkoutos GV, de Groot JR, Kirchhof P, Fabritz L. Reduced left atrial cardiomyocyte PITX2 and elevated circulating BMP10 predict atrial fibrillation after ablation. JCI Insight. 2020 Aug 20;5(16):e139179. doi: 10.1172/jci.insight.139179.
- Derived from this study: PubMed 30898238Berger WR, Neefs J, van den Berg NWE, Krul SPJ, van Praag EM, Piersma FR, de Jong JSSG, van Boven WP, Driessen AHG, de Groot JR. Additional Ganglion Plexus Ablation During Thoracoscopic Surgical Ablation of Advanced Atrial Fibrillation: Intermediate Follow-Up of the AFACT Study. JACC Clin Electrophysiol. 2019 Mar;5(3):343-353. doi: 10.1016/j.jacep.2018.10.008. Epub 2018 Nov 28.
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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.
J.R. De Groot, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Totally Thoracoscopic PV isolation in people with Atrial Fibrillation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 8 inclusion and 15 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 25 Apr 2017. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary endpoint of the study is freedom of AF after one year after the procedure without the use of antiarrhythmic drugs. (time frame: One year). 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 NCT01091389, which also lists 6 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 25 Apr 2017.