Atrial Fibrillation (AF)
Conditions
Keywords
Atrial Fibrillation, Pulsed Field Ablation, LGE-CMR
Brief summary
Rationale: Effectiveness of thermal ablation techniques for pulmonary vein isolation, to treat atrial fibrillation (AF), are hampered by frequent pulmonary vein reconnection and risks of collateral tissue injury. Pulsed field ablation (PFA) offers a non-thermal, tissue-specific alternative that may provide more durable isolation while also reducing procedural risks. While early data for the CE-marked VARIPULSE™ PFA system are promising, long-term lesion durability remains mostly unquantified. To obtain a definitive estimate of PFA effectiveness, a systematic invasive re-mapping approach is required. Advanced cardiac magnetic resonance (CMR) imaging can quantify atrial fibrosis after PVI across different ablation modalities, but it is unknown how well these imaging findings correspond with invasive electrical mapping. In the current study, CMR serves as a complementary modality to explore whether imaging-based tissue changes align with invasively confirmed long-term isolation. Objective: The primary objective is to evaluate the long-term durability of pulmonary vein isolation (PVI) using the VARIPULSE™ Pro PFA system, as defined by the rate of electrical reconnection during systematic invasive re-mapping at three months. Study design: Prospective multicenter intervention study. Study population: Patients ≥ 18 years old, eligible for primary PVI according to ESC guidelines, without contraindications for gadolinium-based contrast-enhanced CMR imaging. Intervention: Patients will undergo PVI using PFA with the VARIPULSE™ catheter. After 3-4 months, a re-map procedure will be performed to assess lesion durability and to re-isolate any electrical reconnections. Main study parameters/endpoints: Primary outcome measure: Patient-level PV lesion durability. Secondary outcome measures: Percentage chronic isolation for each PV; Location of reconnection during re-map and lesion characteristics; Presence, location, size, volume and composition of acute (within 72 hours) and chronic (3 months) ablation lesions and collateral tissue damage on CMR (in the atrial wall and surrounding structure); Procedural fluoroscopy time and radiation dose; Percentage direct isolation for each pulmonary vein (PV); Acute PV reconnection for each PV; Percentage freedom from atrial achyarrhythmias at 12 months follow-up; Incidence of procedure related adverse events. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation involves standard PVI care with additional CMR imaging and an invasive re-map procedure. Early studies show that PFA with the VARIPULSE™ catheter is safe, and the extra imaging adds only minimal burden or risk. The re-map study carries the same risks as standard ablation. Overall, the study is expected to provide valuable insights that may further improve patient care and outcomes in atrial fibrillation.
Interventions
DEVICEPulsed Field Ablation (PFA) with the VARIPULSE™ catheter
Pulsed field ablation (PFA) is a non-thermal catheter ablation technology that creates myocardial lesions through irreversible electroporation by delivering short, high-voltage electrical pulses. This mechanism preferentially affects cardiomyocytes while minimizing damage to adjacent structures such as the esophagus, phrenic nerve, and pulmonary veins. The VARIPULSE™ catheter is a variable-loop, multielectrode, biphasic PFA catheter integrated with the CARTO® 3 electroanatomical mapping system. It is designed to perform pulmonary vein isolation by delivering pulsed electrical fields around the pulmonary vein ostia. In this study, the VARIPULSE™ catheter will be used for pulmonary vein isolation in patients with atrial fibrillation, followed by systematic invasive remapping to assess long-term pulmonary vein isolation durability and reconnection rates.
Sponsors
Radboud University Medical Center
Amsterdam UMC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years of age * AF and eligible for index PVI according to current ESC guidelines
Exclusion criteria
* Unwilling or unable to give written informed consent * Prior left atrial ablation * Other left atrial arrhythmias including atrial flutters * Prior left atrial surgery * Severe mitral valve regurgitation * Contraindication for gadolinium-based contrast agents * Contraindications for CMR (including metallic implants, cochlear implants, cardiac devices, neurostimulation systems, claustrophobia) * Renal insufficiency (eGFR \< 30 ml/min)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-level pulmonary vein lesion durability | Determined during invasive re-mapping, performed 3-4 months after pulmonary vein isolation (PVI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PV reconnection for each PV, the location of PV reconnection, the lesion characteristics, and the re-intervention rate during the invasive re-map procedure | Determined during invasive re-mapping, performed 3-4 months post-PVI | — |
| Presence, location, size, volume and composition of acute (within 72 hours) and chronic (3 months) ablation lesions and collateral tissue damage on CMR (in the atrial wall and surrounding structure) | Within 72 hours post-PVI and after 3 months post-PVI | — |
| Procedural fluoroscopy time and radiation dose | During PVI procedure | — |
| Percentage direct isolation for each PV | During PVI procedure | — |
| Acute PV reconnection for each PV | PVI procedure | — |
| Percentage freedom from atrial tachyarrhythmias | At 3 months and 12 months follow-up | — |
| Incidence of procedure related adverse events | During PVI procedure, and during re-map procedure | including: atrio-esophageal fistula, cardiac tamponade/perforation, death, embolic event, esophageal injury, major vascular access complication, myocardial infarction, pericarditis, phrenic nerve injury/diaphragmatic paralysis, pulmonary vein stenosis, stroke/transient ischemic attack. |
Outcome results
None listed