Magnetic Resonance Imaging for lesion visualization after catheter ablation for treatment of atrial fibrillatio
- Conditions
- paroxysmal atrial fibrillation10007521
- Registration Number
- NL-OMON54655
- Lead Sponsor
- HagaZiekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 96
- 18 years of older
- Diagnosed with paroxysmal atrial fibrillation
- Planned to undergo catheter ablation
- Written informed consent present
- 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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters: visualization and quantification of atrial edema and<br /><br>scar after catheter ablation at different time points using CMR.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters: oesophagus damage, left atrial volume index (LAVI),<br /><br>left atrial wall thickness, diameter pulmonary veins, pre-existent scar tissue,<br /><br>MRI thrombus detection (CT and TOE redundancy), atrial function pre- and<br /><br>post-ablation. </p><br>