To compare the effectiveness of PVI and VATS-PVI. Secondary objectives are to compare the duration of hospitalisation, quality of Life, cost and to compare the satisfaction of the patients.
ID
Source
Brief title
Condition
- Other condition
- Cardiac arrhythmias
- Cardiac therapeutic procedures
Synonym
Health condition
minimaal invasieve interventie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of patients without a recurrence of AF, without AADs, within a
follow-up period of at least 12 months after a stabilisation period of 90 days
after the initial procedure. An episode of AF is defined as an episode of at
least 30 seconds duration.
Secondary outcome
Secondary objectives include the duration and cost of hospitalization,
discomfort during admission, assessment and experienced AF burden during
follow-up of procedural impact on the patient and time to recurrence after
intervention. A complication register will also be kept.
Background summary
Recent studies demonstrated that radiofrequency isolation of the pulmonary
veins (PVI) and surgically video assisted thorascopic pulmonary vein isolation
(VATS-PVI) are acceptable or even superior alternatives to antiarrhythmic drug
therapy in patients with symptomatically paroxysmal atrial fibrillation (AF).
However, data comparing effectiveness in both interventions are limited.
Study objective
To compare the effectiveness of PVI and VATS-PVI. Secondary objectives are to
compare the duration of hospitalisation, quality of Life, cost and to compare
the satisfaction of the patients.
Study design
The Video Assisted Thoracoscopic pulmonary vein isolation versus percutaneous
Catheter Ablation in atrial fibrillation Trial (VATCAT) is a prospective single
center study.
Intervention
Percutaneous catheter ablation (n=104) versus video-assisted epicardial
ablation and left atrial appendage exclusion (n=52). 2:1 randomization
Study burden and risks
Using only routine non-pharmacological interventions will have no extra risk
or burden for the patients. The two most important element of this study is the
study design assign patients at random to either treatment and the intensive
rhythm follow-up using a 7 day event recorder.
Haaksbergerstraat 55
Enschede 7513ER
NL
Haaksbergerstraat 55
Enschede 7513ER
NL
Listed location countries
Age
Inclusion criteria
* Patients > 18 years of age
* Documented, symptomatic, episodes of paroxysmal or persistent AF
* During the last 6 months patients must have at least 2 documented episodes of AF, despite the use of at least 1 anti arrhythmic drug.
* Able of providing informed consent
Exclusion criteria
* Pregnancy
* Unwillingness to use or contra-indications for vitamin K antagonists
* Severely enlarged left atrium (>50 mm) on echocardiography
* Prior AF ablation or AF surgery
* Intracardiac thrombus
* Prior heart surgery or pulmonary disease hampering thoracoscopic 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
In other registers
| Register | ID |
|---|---|
| CCMO | NL32865.044.10 |
| OMON | NL-OMON28912 |