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.
ID
Bron
Verkorte titel
Aandoening
atrial fibrillation Non pharmacological treatment
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
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.
Onderzoeksopzet
3, 6 and 12 months.
Onderzoeksproduct en/of interventie
Percutaneous catheter ablation (n=104) versus video-assisted epicardial ablation and left atrial appendage exclusion (n=52) in a 2:1 randomization.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2349 |
| NTR-old | NTR2455 |
| CCMO | NL32865.044.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39516 |