Evaluation of Ablation Lesions Using Cardiovascular Magnetic Resonance Imaging
ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorR&D Cardiologie
About this trial
Ineffective ablation lesions can cause arrhythmia recurrence after catheter ablation for cardiac arrhythmia. Ablation lesions can be created with various ablation energy modalities. This study uses cardiovascular magnetic resonance imaging to evaluate the ablation lesion characteristics of radiofrequency ablation, ultra-low temperature cryo ablation, and pulsed field ablation. The ablation lesion characteristics of different energy characteristics will be compared. Additionally, arrhythmia recurrence and quality of life will be evaluated for the different energy modalities.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult patients (age ≥18 years old)
Paroxysmal or persistent atrial fibrillation, meeting criteria of the 2020 European Society of Cardiology Guidelines for diagnosis and management of atrial fibrillation
Patients scheduled to undergo catheter ablation for cardiac arrhythmia using one of the following techniques: Radiofrequency ablation (High power, short duration), Ultra-low temperature cryo ablation, or Pulsed field ablation
Disqualifiers
Known (or suspected) allergic reaction to gadolinium
Contraindications for MRI (such as claustrophobia, certain implants, devices, high body mass index).
Pregnancy or breastfeeding
Prior intervention in the left atrium (ablation or surgery)
Trial population
The studied population will be drawn from all patients that are scheduled for catheter ablation at the participating center.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Catheter ablation
DeviceAn ablation catheter is introduced in the heart. Ablation is performed by applying ablation energy to the target tissue. The aim of ablation is to create an ablation lesion that does not conduct the electrical signals that induce or sustain the cardiac arrhythmia.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Radiofrequency ablation, High power, short duration1 intervention
Group B: Ultra-low temperature cryo ablation1 intervention
Group C: Pulsed field ablation1 intervention
Trial outcomes
Primary outcomes
1
Length of gaps in the ablation lesions
Cardiovascular magnetic resonance imaging is used to visualize the ablation lesion. If gaps are present in the ablation lesion, the length of the gaps is measured in millimeter.
Time frame
At 3 months follow upSecondary outcomes
1
Number of gaps in the ablation lesion
Cardiovascular magnetic resonance imaging is used to visualize the ablation lesion. The number of gaps in the ablation lesion are counted.
Time frame
At 3 months follow up2
Location of gaps in the ablation lesion
Cardiovascular magnetic resonance imaging is used to visualize the ablation lesion. If gaps are present in the ablation lesion, the location of the gaps is recorded.
Time frame
At 3 months follow up3
Recurrence of atrial arrhythmia
Ambulatory rhythm monitoring will be performed at 3 and 12 months follow up to assess for recurrences of atrial arrhythmia (i.e. atrial fibrillation, atrial flutter, atrial tachycardia). Additionally, planned and symptom-driven electrocardiograms are assessed for atrial arrhythmia.
Time frame
Until 1 year of follow up4
Atrial arrhythmia burden
Ambulatory rhythm monitoring will be performed at baseline, 3 and 12 months follow up to assess the atrial arrhythmia (i.e. atrial fibrillation, atrial flutter, atrial tachycardia) burden (proportion of time in atrial arrhythmia).
Time frame
Baseline, 3 and 12 months follow upSponsors and contacts
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Source ClinicalTrials.gov