Evaluating PVI Using CMR

Amsterdam UMC, location VUmc

Status: Not yet enrolling

Conditions: Atrial Fibrillation

Treatments: Procedure: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT05437549

NL75456.029.20

Details and patient eligibility

About

Using state of the art cardiac magnetic resonance imaging techniques, characterization of ablation lesions in the early phase after pulmonary vein isolation ablation in atrial fibrillation patients, and relate findings to the ablation scar at 3 months follow up and atrial fibrillation-free survival at 1 year.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (age ≥18 years old)
• Paroxysmal or persistent AF meeting guideline criteria.
• Anticipated PVI using index-guided radiofrequency ablation techniques.
• Availability of LGE-CMR images within 3 months before anticipated PVI.

Exclusion criteria

• History of catheter ablation
• History of cardiac surgery.
• History of chest radiation therapy
• Estimated glomerular filtration rate (eGFR) <45 ml/min/kg
• Known (or suspected) allergic reaction to gadolinium
• Contraindications for CMR (such as claustrophobia, certain implants, devices, high body mass index).
• Inability to schedule CMR <48h after PVI
• Long-term use of anti-inflammatory medication, except for the use of nonsteroidal anti-inflammatory drugs
• Autoimmune disease or chronic inflammatory illness.
• Pregnancy of breast feeding

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

PVI

Other group

Treatment:

Procedure: MRI