To perform a pre-study to assess the feasibility of DE-MRI to assess lesion size, transmurality and completeness of pulmonary vein isolation. The study will be performed to determine if and how DE-MRI can be used in a larger subsequent multicentre…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
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 pulmonary vein isolation. 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 contact-feedback which could be included in the
MERCI-AF study.
Background summary
Radiofrequency pulmonary vein isolation represents an established therapy for
treating atrial fibrillation. 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 just become available.
Effectiveness of radiofrequency ablation by these catheters has recently been
demonstrated in humans.
Recently, DE-MRI has emerged as an effective method to noninvasively assess and
quantify the extent of left atrial structural remodelling. The extent of LA
fibrosis assessed by high-resolution DE-MRI has been introduced as an
independent predictor of RF ablation failure. To demonstrate the superiority of
using the contact 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 pulmonary
vein isolation and relate this to clinical outcome.
Study objective
To perform a pre-study to assess the feasibility of DE-MRI to assess lesion
size, transmurality and completeness of pulmonary vein isolation. 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
The study is designed as a feasibility study.
Intervention
Isolation of left or right sided (1:1 randomization) pulmonary veins with
feedback on, the controlateral side is isolated using the same catheter but
with feedback off.
Study burden and risks
Since in this study a procedure which is common clinical practice will be
performed, there is no extra risk or burden associated with the intervention.
The only part in the study differing from common clinical practice is the
post-procedural MRI, the patient will not have to schedule an extra visit of
the hospital since the visit will be combined with the common follow-up visit.
The MRI will take about an hour.
Haaksbergerstraat 55
Enschede 7531 ER
NL
Haaksbergerstraat 55
Enschede 7531 ER
NL
Listed location countries
Age
Inclusion criteria
• Paroxysmal atrial fibrillation for which >= 1 electrical and/or chemical cardioversions and persistent atrial fibrillation, eligible for pulmonary vein isolation 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
• Age < 18 years.
• Pregnancy
• Life or follow-up expectancy < 12 months.
• Previous pumonary vein isolation in history.
• Contrast allergy.
• Creatin clearance level lower than 60.
• MRI scanning not possible (e.g. because of metal implant or claustrophobia).
• Abnormal left atrium anatomy. This will lead to exclusion after inclusion but before andomisation.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| Other | In clinicaltrials.gov. Nog geen identificatienummer |
| CCMO | NL45733.044.13 |