Atrial Fibrillation (AF)NCT07083115
Developing MRI Technologies for Atrial Fibrillation
An observational study of Atrial Fibrillation (AF), run by The Cleveland Clinic at 1 site in United States.
Trial summary
To measure image quality of damaged areas of the heart in patients with Atrial fibrillation using the contrast Gadopiclenol vs conventional Gadolinium-based contrast agents(GBCA) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2025to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients screened for atrial fibrillation from established afib clinics
Who may be able to join
- -Diagnosis of Atrial Fibrillation
Who cannot join
- Contraindications to MRI
- Contraindications to Gadolinium based contrast agents.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
To measure image quality of damaged areas of the heart in patients with Atrial fibrillation using the contrast Gadopiclenol vs conventional Gadolinium-based contrast agents(GBCA)
Read the detailed description
With the use of gadolinium-based contrast agents (GBCA), cardiac MRI has become the clinical gold standard in tissue characterization of fibrosis in the ventricular myocardium. More recently, contrast enhanced cardiac MRI using standard class I GBCA was proposed to reveal fibrosis in the left atrium to characterize AF via the DECAF and DECAF II studies.
Unfortunately, the results were negative with the culprit reason being the lack of clear visualization of the enhanced regions. This claim was substantiated in a recent 2024 Langendorff (reanimated ex vivo) human heart study in AF patients showing clearly the presence of fibrosis with microscopy and more importantly it showed contrast enhanced MRI can also visualize the fibrosis an equivalent 4x dose of GBCA. However, the study was performed ex vivo and no follow up in vivo study was performed to test the in vivo viability. Thus the investigators propose the unique use of standard dose of Gadopiclenol (Elucerim), a novel high relaxivity agent, contrast enhanced MRI to scan AF patients to identify and characterize areas of fibrosis and validate the electrophysiology dysfunction in those same regions.
It is hypothesized that the Gadopiclenol can provide an improved enhancement as compared to the use of conventional GBCA like Gadovist and potentially can better reveal the AF fibrotic infiltrate. Furthermore, the higher contrast to noise ratio (CNR) of the lesion will support a significantly higher spatial resolution and potentially enable sub-mm high resolution imaging.
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Cardiac MRI, Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality
To demonstrate standard dose (0.05mmol/kg) of Gadopiclenol cardiac MRI significantly improves the enhancement of AF compared with standard dose (0.1mmol/kg) of conventional GBCA agents. Research MRI data will be reviewed against any standard clinical MRI available in the patient's medical record.
Measured: At completion of each MRI
Secondary outcomes (1)
High resolution Cardiac MRI for improved imaging of AF
To demonstrate standard dose (0.05mmol/kg) of Gadopiclenol can enable ultra-high resolution sub-mm cardiac 3D MRI scan for significantly improved imaging of AF. AF patients (N=100), will be recalled for a research scan using the proposed Gadopiclenol contrast agent. The research scan will use a novel 0.9 mm isotropic 3D LGE scan. Wall sharpness measured in units of (1/mm) and lesion CNR will be calculated for both scans and compared. Scan time for both sequences will be made equal.
The primary outcome is in Aim 1 of comparing Gadopiclenol cardiac MRI scans with conventional GBCA cardiac MRI in the context of LA enhancement via contrast to noise ratio (CNR). Previous work in our group using a standard dose of GBCA in RF ablated pigs shows an effect size of about 1.0 in CNR between Gadopiclenol and conventional GBCA in LV enhancement. Assuming this effect size, 80% statistical power, and an alpha = 0.5, it would require at least 32 subjects.
Measured: At completion of each MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start16 Jan 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Guerbet
- Responsible party
- Principal investigator, Christopher Nguyen, The Cleveland Clinic
- Investigators
- Christopher Nguyen, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083115
- Sponsor's protocol ID
- 25-073
- Status last verified
- Mar 2026
- First submitted
- 16 Jul 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing MRI Technologies for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07083115
- Acronym / sponsor ID
- 25-073
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Cardiac MRI, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Guerbet
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 24 Jul 2025 (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.
To measure image quality of damaged areas of the heart in patients with Atrial fibrillation using the contrast Gadopiclenol vs conventional Gadolinium-based contrast agents(GBCA)
Detailed description
With the use of gadolinium-based contrast agents (GBCA), cardiac MRI has become the clinical gold standard in tissue characterization of fibrosis in the ventricular myocardium. More recently, contrast enhanced cardiac MRI using standard class I GBCA was proposed to reveal fibrosis in the left atrium to characterize AF via the DECAF and DECAF II studies.
Unfortunately, the results were negative with the culprit reason being the lack of clear visualization of the enhanced regions. This claim was substantiated in a recent 2024 Langendorff (reanimated ex vivo) human heart study in AF patients showing clearly the presence of fibrosis with microscopy and more importantly it showed contrast enhanced MRI can also visualize the fibrosis an equivalent 4x dose of GBCA. However, the study was performed ex vivo and no follow up in vivo study was performed to test the in vivo viability. Thus the investigators propose the unique use of standard dose of Gadopiclenol (Elucerim), a novel high relaxivity agent, contrast enhanced MRI to scan AF patients to identify and characterize areas of fibrosis and validate the electrophysiology dysfunction in those same regions.
It is hypothesized that the Gadopiclenol can provide an improved enhancement as compared to the use of conventional GBCA like Gadovist and potentially can better reveal the AF fibrotic infiltrate. Furthermore, the higher contrast to noise ratio (CNR) of the lesion will support a significantly higher spatial resolution and potentially enable sub-mm high resolution imaging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients screened for atrial fibrillation from established afib clinics
Key inclusion criteria (1 listed)
- -Diagnosis of Atrial Fibrillation
Key exclusion criteria (2 listed)
- Contraindications to MRI
- Contraindications to Gadolinium based contrast agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Image quality
Time frame: At completion of each MRI
To demonstrate standard dose (0.05mmol/kg) of Gadopiclenol cardiac MRI significantly improves the enhancement of AF compared with standard dose (0.1mmol/kg) of conventional GBCA agents. Research MRI data will be reviewed against any standard clinical MRI available in the patient's medical record.
1 secondary outcome
High resolution Cardiac MRI for improved imaging of AF
Time frame: At completion of each MRI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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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.
Christopher Nguyen, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF), run by The Cleveland Clinic at 1 site in United States.
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 1 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Image quality (time frame: At completion of each MRI). 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 23 Mar 2026; AzTrials last refreshed its copy on 28 Oct 2026.