Evaluating PVI Using CMR

June 24, 2022 updated by: Luuk Hopman, Amsterdam UMC, location VUmc

CMR Characterization of Ablation Lesions Following Pulmonary Vein Isolation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PVI
Procedure: MRI
MRI prior to PVI, acutely after PVI, and 3 months after PVI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ablaton scar
Time Frame: 3 months
The correlation between ablation lesion characteristics in the early phase after PVI and ablation scar at 3 months follow up.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AF recurrence
Time Frame: 1 year
The relation between ablation lesion characteristics and AF recurrence at 1 year after the ablation procedure
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

June 17, 2022

First Submitted That Met QC Criteria

June 24, 2022

First Posted (Actual)

June 29, 2022

Study Record Updates

Last Update Posted (Actual)

June 29, 2022

Last Update Submitted That Met QC Criteria

June 24, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL75456.029.20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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