Evaluating PVI Using CMR

A

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)

40 participants in 1 patient group

PVI
Other group
Treatment:
Procedure: MRI

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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