|- candidate number||15913|
|- NTR Number||NTR4357|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-dec-2013|
|- Secondary IDs|| |
|- Public Title||An MRI-validated study of Electrical Coupling Index catheter superiority in AF ablation
|- Scientific Title||An MRI-validated study of Electrical Coupling Index catheter superiority in AF ablation
|- ACRONYM||Merci-AF pre study|
|- hypothesis||DE-MRI is feasible 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 larger subsequent multicentre trial (MERCI-AF study). |
|- Healt Condition(s) or Problem(s) studied||Atrial Fibrillation, DCE-MRI, Ablation therapy|
|- 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||A potential subject who meets any of the following criteria will be excluded from participation in this study:|
Age < 18 years.
Life or follow-up expectancy < 12 months.
Previous PVI in history.
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 PVs ≠ 4 . This will lead to exclusion after inclusion but before randomisation.
|- mec approval received||no|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2014|
|- planned closingdate||1-dec-2015|
|- Target number of participants||10|
|- Interventions||PVI using electrical coupling information (one side of PV's) or using no celectrical coupling information (other side of PV's)|
|- Primary outcome||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 outcome||To collect data on the use of ECI-feedback which could be included in the MERCI-AF study.|
|- Timepoints||After 10 patients|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||dr. J.M. Opstal, van|
|- CONTACT for SCIENTIFIC QUERIES||dr. J.M. Opstal, van|
|- Sponsor/Initiator ||Medisch Spectrum Twente|
(Source(s) of Monetary or Material Support)
|Medisch Spectrum Twente, Enschede|
|- Brief summary||Radiofrequency (RF) pulmonary vein isolation (PVI) represents an established therapy for treating atrial fibrillation (AF). The quality of catheter tip-to-tissue contact plays a critical role in ablation safety and efficacy. Catheters providing feedback on this tip-to-tissue contact have recently become available. Effectiveness of RF ablation by these catheters has recently been demonstrated in humans 13. MRI has shown to be of great value in assessing lesion size and transmurality in-vivo. To demonstrate the superiority of using the ECI catheters to conventional catheters for the effectiveness of AF ablation, post procedural MRI with delayed enhancement (DE-MRI) can possibly assess lesion size, transmurality of the lesion and completeness of PVI and relate this to clinical outcome. |
|- Main changes (audit trail)|
|- RECORD||20-dec-2013 - 24-mrt-2014|