NCT05437549

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jul 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 29, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

June 29, 2022

Status Verified

June 1, 2022

Enrollment Period

1.5 years

First QC Date

June 17, 2022

Last Update Submit

June 24, 2022

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Ablaton scar

    The correlation between ablation lesion characteristics in the early phase after PVI and ablation scar at 3 months follow up.

    3 months

Secondary Outcomes (1)

  • AF recurrence

    1 year

Study Arms (1)

PVI

OTHER
Procedure: MRI

Interventions

MRIPROCEDURE

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

PVI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

June 17, 2022

First Posted

June 29, 2022

Study Start

July 1, 2022

Primary Completion

January 1, 2024

Study Completion

July 1, 2024

Last Updated

June 29, 2022

Record last verified: 2022-06