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…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study is freedom of AF after one and two years
after the procedure with or 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
The secondary endpoints include:
1) Freedom of AF after one and two years after the procedure without the use of
any antiarrhythmic drug. Definition of freedom of AF as above.
2) Improvement of functional status as measured by the RAND 36 quality of life
questionnaires
Background summary
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 antiarrhythmic 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.
Study objective
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 130 patients each will be
studied.
Study design
This is a single center, randomized single blinded study
Intervention
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 burden and risks
The intervention carries no risks other than the risks associated with the
minimally invasive surgery (the standard treatment).
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients with paroxysmal or persistent atrial fibrillation, refractory to at least one antiarrhythmic drug, between 18 and 80 years of age and willing to participate in the study and the follow-up
Exclusion criteria
Catheter treatment for atrial fibrillation within 4 months before inclusion, myocardial infarction within the previous 2 months, heart failure, stroke in the previous 6 months, refuse to take medication, severely enlarged left atrium.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30199.018.10 |