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The goal of this clinical trial is to compare the effect of pulmonary vein isolation on atrial function between pulse-field and cryoablation in patients over the age of 18 with paroxysmal atrial fibrillation. The main question it aims to answer is:
• Is catheter ablation energy (pulse field ablation) revealing a better preservation of the atrial function architecture than with conventional catheter ablation technologies ?
Participants will performed 2 IRMs with injection and completed Quality of Life Questionnaires. They participate in the study for 4 months.
Researchers will compare 2 arms:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary vein isolation by pulse field ablation | Active Comparator |
| |
| Pulmonary vein isolation by cryoablation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary vein isolation by pulse field ablation | Procedure | Pulse Field Ablation (PFA) is a non-thermal energy based on high voltage, ultra-short energy pulses applied selectively to cardiomyocytes. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between baseline (pre-ablation) and post-ablation in the amount of left atrial fibrosis such as quantified by 3D late gadolinium enhancement (g, %) (related to primary objective) (MRI measurement) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between baseline (pre-ablation) and post-ablation in global left atrial strain (%) (related to secondary objective 1) (MRI measurement) | 3 months | |
| Difference between baseline (pre-ablation) and post-ablation in regional left atrial strains (%) (related to secondary objective 1) (MRI measurement) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mikael Laredo, MD, PhD | Contact | +33184827620 | mikael.laredo@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marine CAMUS | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Mikael Laredo | Recruiting | Paris | France | 75013 | France |
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| Pulmonary vein isolation by cryoablation | Procedure | Cryoablation is a conventional thermal energy, also delivered with a single-shot cryoballoon device. |
|
| 3 months |
| Difference between baseline (pre-ablation) and post-ablation LA adipose tissue, measured by CT (cm2, mm3, %) (related to secondary objective 1 and 2) (CT measurement) | 3 months |
| Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by 4D-flow MRI (related to secondary objective 3) (MRI measurement) | 3 months |
| Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by vortices number (related to secondary objective 3) (MRI measurement) | 3 months |
| Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by characterization (n) (related to secondary objective 3) (MRI measurement) | 3 months |
| Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by duration (ms) (related to secondary objective 3) (MRI measurement) | 3 months |
| Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by LA stasis (related to secondary objective 3) (MRI measurement) | 3 months |
| Heart rate measured the day after ablation and 3 months after (related to secondary objective 4) | 3 months |
| SF-36 (Short-Form-36) Physical Health Composite questionnaires measured before ablation (related to secondary objective 4). The minimum value is 0 and the maximum is 800; a higher score means a better result. | 0 day |
| SF-36 (Short-Form-36) Physical Health Composite questionnaires measured 15 days after ablation (related to secondary objective 4). The minimum value is 0 and the maximum is 800; a higher score means a better result. | 15 days |
| Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaires measured before ablation (related to secondary objective 4). The minimum value is 0 and the maximum is 100; a higher score means a better result. | 0 day |
| Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaires measured 15 days after ablation (related to secondary objective 4). The minimum value is 0 and the maximum is 100; a higher score means a better result. | 15 days |
| Numeric rating pain scale (NRS) (0-10) measured 24 hours after ablation (related to secondary objective 4) | 1 day |
| Numeric rating pain scale (NRS) (0-10) measured 15 days after ablation (related to secondary objective 4) | 15 days |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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