NCT07083115

Brief 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)

Trial Health

75
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
28mo left

Started Jan 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress36%
Jan 2025Sep 2028

Study Start

First participant enrolled

January 16, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

2.6 years

First QC Date

July 16, 2025

Last Update Submit

March 19, 2026

Conditions

Atrial Fibrillation (AF)

Keywords

Cardiac MRIAtrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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.

    At completion of each MRI

Secondary Outcomes (1)

  • High resolution Cardiac MRI for improved imaging of AF

    At completion of each MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients screened for atrial fibrillation from established afib clinics

You may qualify if:

  • Diagnosis of Atrial Fibrillation

You may not qualify if:

  • Contraindications to MRI
  • Contraindications to Gadolinium based contrast agents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher Nguyen, PhD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiovascular Innovation Research Center

Study Record Dates

First Submitted

July 16, 2025

First Posted

July 24, 2025

Study Start

January 16, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations

US(1)