St. Antonius Hospital
Nieuwegein, 3435 CM, Netherlands
Location status: Recruiting
Location contact
Bob GS Abeln, MD
CONTACT
0883201212 ext. +31
Bob GS Abeln, MD
SUB_INVESTIGATOR
Lucas VA Boersma, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05432024
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Nieuwegein, 3435 CM, Netherlands
Location status: Recruiting
Bob GS Abeln, MD
CONTACT
0883201212 ext. +31
Bob GS Abeln, MD
SUB_INVESTIGATOR
Lucas VA Boersma, MD, PhD
PRINCIPAL_INVESTIGATOR
Catheter ablation has become a cornerstone in the treatment of atrial fibrillation (AF). Typically, radiofrequency ablation (RFA) and cryoballoon ablation are used to perform pulmonary vein isolation (PVI). This treatment is effective in the majority of patients, but nevertheless 35% of patients have arrhythmia recurrence at 1-year follow up. These recurrence rates have been attributed to multiple factors, including ineffective ablation lesions, presence of non-pulmonary vein arrhythmia triggers, and disease progression.
Ineffective ablation lesions can cause arrhythmia recurrence through electrical reconnection. Electrical reconnection can occur when gaps are present in the ablation line due to non-durable, non-transmural or non-contiguous ablation lesions. Conventionally, ablation lesion assessment is performed using a redo electrophysiology study at three months post-ablation. During a redo electrophysiology study, a catheter is used to measure the local electrical signals to enable identification of sites with electrical reconnection. This method is effective but poses the patient to the procedural risks of these invasive measurements. Cardiovascular magnetic resonance (CMR) imaging may provide an alternative method for the evaluation of ablation lesions. Modern acquisition and post-processing techniques are under development and being used to image the atrial wall. These techniques may effectively visualize the fibrous tissue of ablation lesions, which enables a non-invasive method to characterize the lesions of catheter ablation.
To reduce arrhythmia recurrence caused by electrical reconnection, several novel ablation techniques have been developed in the last years. These novel ablation techniques can potentially reduce arrhythmia recurrence by enabling the creation of durable, transmural and contiguous ablation lesions. Novel ablation modalities include ultra-low temperature cryoablation (ULTC) and pulsed field ablation (PFA) that use near-critical nitrogen and pulsed electrical fields to create ablation lesions. The initial clinical outcomes of both ablation modalities are favorable, but little data are available on the ablation lesion characteristics. Additionally, novel techniques were developed to improve the procedural outcomes of RFA. High power, short duration (HPSD) RF energy applications cause more resistive and less conductive tissue heating compared to convention RFA, which results in more durable ablation lesions and less arrhythmia recurrence while safety outcomes are similar.
This study aims to use CMR to evaluate the ablation lesion characteristics of HPSD RFA, ULTC and PFA. This novel information can be used to quantitatively compare different ablation modalities. Furthermore, this study could contribute to our knowledge on ablation lesion formation, which may be used to further develop our ablation strategies.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An 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.
Time frame: At 3 months follow up
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 up
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 up
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: Until 1 year of follow up
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: Baseline, 3 and 12 months follow up
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 up
A validated questionnaire (AFEQT) will be used to evaluate the atrial fibrillation related quality of life at baseline, 3 and 12 months follow up.
Contact information is provided by the study sponsor or research team.
R&D Cardiologie
Other
Acronym: ENABLE-CMR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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