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The CAVIAR-trial


- candidate number21746
- NTR NumberNTR5081
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-mrt-2015
- Secondary IDs51954 ABR
- Public TitleThe CAVIAR-trial
- Scientific TitleCatheter ablation versus video assisted thoracoscopic surgery for the treatment of (longstanding) persistent atrial fibrillation
- ACRONYMCAVIAR
- hypothesisThe hypothesis is that minimal invasive surgical ablation through video assisted thoracoscopic surgey as a primary treatment in patients suffering from (longstanding) persistent atrial fibrillation is superior to transvenous catheter ablation
- Healt Condition(s) or Problem(s) studiedAtrial Fibrillation, Chronic
- Inclusion criteria- Patients age is > 18 years
- Patients with persistent or longstanding persistent atrial fibrillation. Persistent AF is defined as sustained episodes of atrial fibrillation lasting >7 days. Longstanding persistent AF is defined as sustained episode lasting >1 year.
- Patients undergoing a first time invasive treatment procedure for persistent atrial fibrillation
- AF must be recorded at least once by ECG, holter, telemetry, loop recorder or internal device.
- Patients must give informed consent to participate
- Exclusion criteria- Patients suffering from paroxysmal atrial fibrillation. Paroxysmal AF is defined as episodes of AF that terminates spontaneously within 7 days.
- Patients suffering from AF secondary to a reversible cause as electrolyte imbalance or hyperthyroidism.
- Body mass index >40
- Active infection or sepsis
- Unstable angina, myocardial infarction within the previous 6 months
- Patients with any contra-indications for electrophysiologic study and ablation in the left atrium:
-pregnancy
-presence of a left atrial thrombus
- Patients with any contra-indications for video assisted thoracoscopic surgery:
- prior lung/cardiac surgery
- pleural adhesions
- elevated hemidiaphragm
- mitral or aortic valve regurgitation above grade 2
- moderate to severe mitral or aortic stenosis
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2015
- planned closingdate1-feb-2018
- Target number of participants60
- Interventions-Catheter ablation
-Surgical ablation
- Primary outcomeThe primary objective of the study is to evaluate which treatment- surgical ablation or catheter ablation- is most effective in treating persistent and longstanding persistent atrial fibrillation measured by success at 12 months after 1 procedures.
- Secondary outcomeThe incidence of periprocedural complications, clinical success after 12 months, procedural duration, number of repeat procedures, success and clinical success after 2 procedure after 12 months, quality of life measurements before and 6 months after the first procedure.
- TimepointsFollow up will take place at 3,6 and 12 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES C. Teunissen
- CONTACT for SCIENTIFIC QUERIES C. Teunissen
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- Publications
- Brief summaryIntroduction
Catheter ablation (CA) is a successful treatment option in patients suffering from paroxysmal atrial fibrillation (AF). In patients with (longstanding) persistent AF the results are substantially lower. Over the last years, minimal invasive surgical ablation (SA) through video assisted thoracoscopic surgery (VATS) has been developed. Compared with CA, SA may be more effective, especially after one procedure. No randomized controlled trials directly comparing CA and SA for the primary treatment of (longstanding) persistent AF have been performed yet.
Purpose
The aim of this study is to determine which treatment, SA or CA, is superior as a primary treatment in patients suffering from (longstanding) persistent atrial fibrillation (AF) measured by success at 12 months after 1 procedure
Methods
The CAVIAR-trial is a single center, randomized intervention study with a follow up of 12 months. 60 Patients will be randomized in either:
o Transvenous catheter ablation
o Minimal invasive surgical ablation through video assisted thoracoscopic surgey
The follow-up protocol is the same as standard care. Patients will visit the outpatient clinic at 3, 6, and 12 months post-ablation.
- Main changes (audit trail)
- RECORD3-mrt-2015 - 25-apr-2015


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