No registrations found.
ID
Source
Brief title
Health condition
Atrial Fibrillation
DE-MRI
Ablation
Sponsors and support
Intervention
Outcome measures
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.
Background 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 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.
Study objective
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).
Study design
After 10 patients
Intervention
PVI using electrical coupling information (one side of PV's) or using no celectrical coupling information (other side of PV's)
Medisch Spectrum Twente
Haaksbergerstraat 55
J.M. Opstal, van
Enschede 7513 ER
The Netherlands
j.vanopstal@mst.nl
Medisch Spectrum Twente
Haaksbergerstraat 55
J.M. Opstal, van
Enschede 7513 ER
The Netherlands
j.vanopstal@mst.nl
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.
• 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4116 |
| NTR-old | NTR4357 |
| Other | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |