Evaluate and quantify whether lesion formation can be visualized using MRI in subjects undergoing a catheter ablation for paroxysmal atrial fibrillation.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters: visualization and quantification of atrial edema and
scar after catheter ablation at different time points using CMR.
Secondary outcome
Secondary study parameters: oesophagus damage, left atrial volume index (LAVI),
left atrial wall thickness, diameter pulmonary veins, pre-existent scar tissue,
MRI thrombus detection (CT and TOE redundancy), atrial function pre- and
post-ablation.
Background summary
Catheter ablation for atrial fibrillation (AF) has become a first-line therapy,
whereas pulmonary vein antrum isolation (PVAI) is still widely accepted as the
cornerstone of ablation therapy in all types of AF. Unfortunately, due to
insufficient lesion creation many patients require subsequent catheter ablation
(CA) procedures to treat AF recurrence due to electrical reconnections between
left antrum (LA) and pulmonary veins (PV). Visualization of lesion creation by
the use of cardiac MRI (CMR) might improve clinical outcomes and reduce the
need for additional CA procedures. In this pilot study, we will evaluate lesion
visualization at different points in time for both edema and scar tissue
evolution for the purpose of determining the optimal time points for lesion
visualization in the acute phase (edema) and in the later phase (scar).
Study objective
Evaluate and quantify whether lesion formation can be visualized using MRI in
subjects undergoing a catheter ablation for paroxysmal atrial fibrillation.
Study design
Monocenter, investigator-initiated, prospective, explorative, observational,
longitudinal study.
Study burden and risks
Four MRI exams in a fixed time schedule will be performed:
- 1) MRI prior to ablation (within 1 week prior to ablation),
- 2) MRI directly after ablation (<1 hour post-ablation),
- 3) One of the following time points: 3a) MRI 24 hours post-ablation, 3b) MRI
one week post-ablation, 3c) MRI one month post-ablation
- 4) MRI three months post-ablation
Although MRI is a non-invasive diagnostic imaging technique it can be
associated with nau-sea, headache and general discomfort, especially in
subjects suffering from claustrophobia. The subject risks associated with the
additional MRIs are neglectable. The potential burden is in the associated time
of the additional MRIs and the associated gadolinium containing con-trast
agents. However, we will minimize this burden by planning most of the MRIs
during hos-pitalization or regular hospital visits. In every patient the MRI
exam is performed at time-point 1), 2) and 4). Although anesthesia used for
catheter ablation is prolonged for the 2) MRI, this decreases the burden of the
experience of MRI for the subject.
Els Borst-Eilersplein 275
Den Haag 2545 AA
NL
Els Borst-Eilersplein 275
Den Haag 2545 AA
NL
Listed location countries
Age
Inclusion criteria
- 18 years of older
- Diagnosed with paroxysmal atrial fibrillation
- Planned to undergo catheter ablation
- Written informed consent present
Exclusion criteria
- Unable to provide informed consent
- Contraindications for a diagnostic cardiac MRI (unstable implants, implanted
devices <30 days, neuro clips, allergy to gadolinium contrast medium, renal
impairment (eGFR < 30mL/min/1.73 m2)
- Contraindications for catheter ablation (documented intracardial thrombus,
tumour, bleeding, coagulation or other abnormality which limits catheter
ablation)
- Myocardial infarction, of a maximum of 60 days prior to inclusion
- Instable angina pectoris
- History of cerebrovascular event
- Clinically significant structural heart disease (this includes: tricuspid
valve insufficiency or stenosis and other congenital heart diseases) which
limit the insertion of the catheter, as determined by the physician
- Uncompensated chronic heart failure
- The arrhythmia is secondary to an electrolyte disbalance, thyroid disease, or
any other reversible non-cardiac cause
- Known sensitivity for heparin or warfarin
- Active or systemic infection
- Any other significant non-controllable or instable medical condition
- Pregnancy
- Life expectancy of less than 12 months
- Subjects with prosthetic valves
- Subjects of 75 years of age or older
- Weight of more than 200 kilos
- Patients with inadequate anticoagulation
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
|---|---|
| CCMO | NL70037.058.19 |