Atrial Fibrillation DE-MRI Ablation
Conditions
Interventions
PVI using electrical coupling information (one side of PV's) or using no celectrical coupling information (other side of PV's)
Sponsors
Medisch Spectrum Twente Enschede
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Paroxysmal atrial fibrillation for which ≥ 1 electrical and/or chemical cardioversions and persistent atrial fibrillation, eligible for PVI according to current international guidelines. • Age < 70 years. • Willing and able to sign informed consent. • Willing to and capable of following the requested study procedures.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Age < 18 years. • Pregnancy • Life or follow-up expectancy < 12 months. • Previous PVI in history. • Contrast allergy. • Creatin clearance level lower than 60. • MRI scanning not possible (e.g. because of metal implant or claustrophobia). • Unsuccessful PVI during first procedure, while already in study. This will lead to exclusion after randomisation. • Abnormal left atrium anatomy defined as number of PV’s ≠ 4 . This will lead to exclusion after inclusion but before randomisation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To perform a pre-study to assess the feasibility of DE-MRI to assess lesion size, transmurality and completeness of PVI. The study will be performed to determine if and how DE-MRI can be used in a subsequent multicentre study (MERCI-AF study). | — |
Secondary
| Measure | Time frame |
|---|---|
| To collect data on the use of ECI-feedback which could be included in the MERCI-AF study. | — |
Contacts
Public ContactJ.M. Opstal, van
Department of Cardiology Medisch Spectrum Twente Haaksbergerstraat 55
Outcome results
None listed