The primary objective of the study is:- to evaluate the burden of AF and quality of life rhythm after thoracoscopic ablation surgery and after port-access concomitant left atrial MAZE surgery by continuous rhythm monitoring (Medtronic Reveal Linq…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of the study is:
- to evaluate the burden of AF and quality of life rhythm after thoracoscopic
ablation surgery and after port-access concomitant left atrial MAZE surgery by
continuous rhythm monitoring (Medtronic Reveal Linq Insertable Cardiac
Monitor*).
Secondary outcome
Secondary objectives are:
- to evaluate freedom from AF/AFl/AT,
- to assess the clinical safety of the procedure
- to assess neurologic outcome (ischemic stroke, hemorrhagic stroke, transient
ischemic attack)
- to evaluate the postoperative biochemical cardio-inflammatory response
(NT-pro-BNP, CRP, IL-6 and troponin levels)
Background summary
Rationale: AF recurrences after ablation therapy (surgical and catheter
ablation) are common within the first months after AF ablation. The temporarily
increased risk of recurrences may be related to atrial edema, local
inflammatory response leading to enhanced automaticity or vulnerability of the
atrial substrate to AF, increased adrenergic tone and changes in fluid and
electrolyte balance. An early recurrence of AF after ablation does not
necessarily indicate long-term ablation failure. Therefore, the definition of
1-year success was stated as freedom from AF/AFL/AT (>30 seconds) off
antiarrhythmic drug therapy as assessed from the end of the 3-month blanking
period to 12 months following the ablation procedure. This statement is based
on literature derived from experience after catheter ablation for AF. It can be
speculated that the amount of tissue necrosis after surgical ablation is higher
compared to catheter ablation. Consequently, the amount of tissue edema in and
around the lines could therefore be more extended and longer lasting.
Furthermore, (thoracoscopic) AF surgery results in some degree of
post-pericardiotomy syndrome which might be responsible for AF recurrences
itself. We hypothesize that the blanking period after (thoracoscopic) surgical
ablation might be longer than the arbitrarily chosen 3 months period after AF
ablation.
Patients suffering from AF suffer from considerable impairment in quality of
life (QoL). One of the main goals of treatment is to restore rhythm to improve
symptoms, and to improve quality of life. The current definition of success
according to the 2014 HRS statement defines a single recurrent episode of
AT/AF/AFl of more than 30 seconds 3 months after ablation as failure while the
actual burden and possibly also the quality of life could potentially have been
improved significantly.
Study objective
The primary objective of the study is:
- to evaluate the burden of AF and quality of life rhythm after thoracoscopic
ablation surgery and after port-access concomitant left atrial MAZE surgery by
continuous rhythm monitoring (Medtronic Reveal Linq Insertable Cardiac
Monitor*).
Secondary objectives are:
- to evaluate freedom from AF/AFl/AT,
- to assess the clinical safety of the procedure
- to assess neurologic outcome (ischemic stroke, hemorrhagic stroke, transient
ischemic attack)
- to evaluate the postoperative biochemical cardio-inflammatory response
(NT-pro-BNP, CRP, IL-6 and troponin levels)
Study design
Single-center, prospective observational cohort study
Study burden and risks
There are no risks associated with participation. During hospitalization the
blood collection for this study will be performed simultaneously with routine
blood collection (2/4). Three months after surgery blood collection will be
performed one more time, simultaneously with a routine visit
Koekoekslaan 1
Nieuwegein 3435 cm
NL
Koekoekslaan 1
Nieuwegein 3435 cm
NL
Listed location countries
Age
Inclusion criteria
-(Longstanding) persisterend or paroxysmal AF
-Accepted for thoracoscopic surgical ablation (TT-maze or port-access
concomitant left atrial MAZE surgery (heartport))
-18 years or older
- The patient is mentally able and willing to give informed consent
- The patient agrees with the implantation of an implantable loop recorder
Exclusion criteria
No ILR implantation prior to surgery
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 | NL56551.100.16 |