Atrial FibrillationNCT05437549
Evaluating PVI Using CMR
A study testing MRI in people with Atrial Fibrillation, run by Amsterdam UMC, location VUmc.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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
About this study
Official title: 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.
- Conditions
- Atrial Fibrillation
- Being tested
- MRI
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
MRI prior to PVI, acutely after PVI, and 3 months after PVI
| Study group | Role | What they receive |
|---|---|---|
| PVI | Other | Not described Receives: Procedure: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ablaton scar
The correlation between ablation lesion characteristics in the early phase after PVI and ablation scar at 3 months follow up.
Measured: 3 months
Secondary outcomes (1)
AF recurrence
The relation between ablation lesion characteristics and AF recurrence at 1 year after the ablation procedure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luuk Hopman, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437549
- Sponsor's protocol ID
- NL75456.029.20
- Status last verified
- Jun 2022
- First submitted
- 17 Jun 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CMR Characterization of Ablation Lesions Following Pulmonary Vein Isolation
- ClinicalTrials.gov ID
- NCT05437549
- Acronym / sponsor ID
- NL75456.029.20
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PVI | Other | Procedure: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI prior to PVI, acutely after PVI, and 3 months after PVI | Procedure or surgery | PVI |
Primary outcome
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.
1 secondary outcome
AF recurrence
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Atrial Fibrillation, run by Amsterdam UMC, location VUmc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ablaton scar (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022; AzTrials last refreshed its copy on 1 Nov 2026.