Evaluating PVI Using CMR
Primary Purpose
Atrial Fibrillation
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Atrial Fibrillation
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PVI
Arm Description
Outcomes
Primary Outcome Measures
Ablaton scar
The correlation between ablation lesion characteristics in the early phase after PVI and ablation scar at 3 months follow up.
Secondary Outcome Measures
AF recurrence
The relation between ablation lesion characteristics and AF recurrence at 1 year after the ablation procedure
Full Information
NCT ID
NCT05437549
First Posted
June 17, 2022
Last Updated
June 24, 2022
Sponsor
Amsterdam UMC, location VUmc
1. Study Identification
Unique Protocol Identification Number
NCT05437549
Brief Title
Evaluating PVI Using CMR
Official Title
CMR Characterization of Ablation Lesions Following Pulmonary Vein Isolation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PVI
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
MRI
Intervention Description
MRI prior to PVI, acutely after PVI, and 3 months after PVI
Primary Outcome Measure Information:
Title
Ablaton scar
Description
The correlation between ablation lesion characteristics in the early phase after PVI and ablation scar at 3 months follow up.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
AF recurrence
Description
The relation between ablation lesion characteristics and AF recurrence at 1 year after the ablation procedure
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Evaluating PVI Using CMR
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