Atrial Fibrillation Ablation and Autonomic Modulation Via Thorascopic Surgery (AFACT)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Totally Thoracoscopic PV isolation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Totally Thoracoscopic PV isolation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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%
- 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.)
Sites / Locations
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
GP ablation
No GP ablation
Arm Description
Thoracoscopic PV isolation with GP ablation
Thoracoscopic PV isolation with no GP ablation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Quality of life
Improvement of functional status as measured by the RAND 36 quality of life questionnaires
Full Information
NCT ID
NCT01091389
First Posted
March 23, 2010
Last Updated
April 24, 2017
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Netherlands Heart Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01091389
Brief Title
Atrial Fibrillation Ablation and Autonomic Modulation Via Thorascopic Surgery
Acronym
AFACT
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
February 23, 2015 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Netherlands Heart Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Totally Thoracoscopic PV isolation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GP ablation
Arm Type
Experimental
Arm Description
Thoracoscopic PV isolation with GP ablation
Arm Title
No GP ablation
Arm Type
Experimental
Arm Description
Thoracoscopic PV isolation with no GP ablation
Intervention Type
Procedure
Intervention Name(s)
Totally Thoracoscopic PV isolation
Other Intervention Name(s)
Mini-Maze, VATS-PVI
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary endpoint of the study is freedom of AF after one year after the procedure without the use of antiarrhythmic drugs.
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Freedom of AF after two years after the procedure without the use of any antiarrhythmic drug
Description
Freedom of AF after two years after the procedure without the use of any antiarrhythmic drug. Definition of freedom of AF as above.
Time Frame
Two Years
Title
Quality of life
Description
Improvement of functional status as measured by the RAND 36 quality of life questionnaires
Time Frame
One Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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%
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J.R. De Groot, MD, PhD
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
City
Amsterdam
ZIP/Postal Code
1100 DD
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
27609676
Citation
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.
Results Reference
result
PubMed Identifier
35264365
Citation
Wesselink 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.
Results Reference
derived
PubMed Identifier
32814717
Citation
Reyat 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.
Results Reference
derived
PubMed Identifier
30898238
Citation
Berger 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.
Results Reference
derived
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Atrial Fibrillation Ablation and Autonomic Modulation Via Thorascopic Surgery
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