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).
ID
Bron
Verkorte titel
Aandoening
Atrial Fibrillation
DE-MRI
Ablation
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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).
Achtergrond van het onderzoek
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 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.
Doel van het onderzoek
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).
Onderzoeksopzet
After 10 patients
Onderzoeksproduct en/of interventie
PVI using electrical coupling information (one side of PV's) or using no celectrical coupling information (other side of PV's)
Algemeen / deelnemers
Medisch Spectrum Twente
Haaksbergerstraat 55
J.M. Opstal, van
Enschede 7513 ER
The Netherlands
j.vanopstal@mst.nl
Wetenschappers
Medisch Spectrum Twente
Haaksbergerstraat 55
J.M. Opstal, van
Enschede 7513 ER
The Netherlands
j.vanopstal@mst.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4116 |
| NTR-old | NTR4357 |
| Ander register | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |