Evaluating PVI Using CMR

NCT ID: NCT05437549

Last Updated: 2022-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PVI

Group Type OTHER

MRI

Intervention Type PROCEDURE

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

Interventions

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MRI

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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Luuk Hopman

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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NL75456.029.20

Identifier Type: -

Identifier Source: org_study_id

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