No registrations found.
ID
Source
Brief title
Health condition
atrial fibrillation Non pharmacological treatment
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
N/A
Study objective
The primary hypothesis of the VATCAT trial is that PVI is superior to VATS-PVI in patients with symptomatic AF in terms of cardiovascular mortality and morbidity, QoL and cost.
Study design
3, 6 and 12 months.
Intervention
Percutaneous catheter ablation (n=104) versus video-assisted epicardial ablation and left atrial appendage exclusion (n=52) in a 2:1 randomization.
Inclusion criteria
1. Patients > 18 years of age;
2. Documented, symptomatic, episodes of paroxysmal or persistent AF;
3. 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;
4. Able of providing informed consent.
Exclusion criteria
1. Pregnancy;
2. Unwillingness to use or contra-indications for vitamin K antagonists;
3. Severely enlarged left atrium (>50 mm) on echocardiography;
4. Prior AF ablation or AF surgery;
5. Intracardiac thrombus;
6. Prior heart surgery or pulmonary disease hampering thoracoscopic surgery.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2349 |
| NTR-old | NTR2455 |
| CCMO | NL32865.044.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39516 |