search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


An MRI-validated study of Electrical Coupling Index catheter superiority in AF ablation – pre study


- candidate number15913
- NTR NumberNTR4357
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-dec-2013
- Secondary IDs 
- Public TitleAn MRI-validated study of Electrical Coupling Index catheter superiority in AF ablation – pre study
- Scientific TitleAn MRI-validated study of Electrical Coupling Index catheter superiority in AF ablation – pre study
- ACRONYMMerci-AF pre study
- hypothesisDE-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) studiedAtrial Fibrillation, DCE-MRI, Ablation therapy
- Inclusion criteriaIn 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 criteriaA 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2014
- planned closingdate1-dec-2015
- Target number of participants10
- InterventionsPVI using electrical coupling information (one side of PV's) or using no celectrical coupling information (other side of PV's)
- Primary outcomeTo 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 outcomeTo collect data on the use of ECI-feedback which could be included in the MERCI-AF study.
- TimepointsAfter 10 patients
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESdr. J.M. Opstal, van
- CONTACT for SCIENTIFIC QUERIESdr. J.M. Opstal, van
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
Medisch Spectrum Twente, Enschede
- PublicationsN/A
- Brief summaryRadiofrequency (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 1–3. 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)
- RECORD20-dec-2013 - 24-mrt-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl