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Evaluating PVI Using CMR

CMR Characterization of Ablation Lesions Following Pulmonary Vein Isolation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05437549
Enrollment
40
Registered
2022-06-29
Start date
2022-07-01
Completion date
2024-07-01
Last updated
2022-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief summary

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.

Interventions

PROCEDUREMRI

MRI prior to PVI, acutely after PVI, and 3 months after PVI

Sponsors

Amsterdam UMC, location VUmc
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ablaton scar3 monthsThe correlation between ablation lesion characteristics in the early phase after PVI and ablation scar at 3 months follow up.

Secondary

MeasureTime frameDescription
AF recurrence1 yearThe relation between ablation lesion characteristics and AF recurrence at 1 year after the ablation procedure

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026