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TerminatedNo phase

Peri-Atrial Inflammatory Fat and Atrial Fibrillation

Key facts

Who runs it
Johns Hopkins University
Where
Baltimore, United StatesSee the site
Trial code
Status
Terminated
People taking part
4 people enrolled
Started
19 Feb 2021
Ended
12 Nov 2024
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Catheter ablation
Record updated
20 November 2024
Why it stopped
PI left the institution

Who can take part

Age
18 years to 100 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • Ages 18 to 100 years
  • Adult men and women undergoing the first catheter ablation of AF for whom cardiac CT is clinically indicated to guide the procedure

Who cannot take part

  • Known history of anaphylaxis to radiocontrast
  • Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m\^2
  • Inability to provide consent

Where in United States

  • Johns Hopkins HospitalBaltimore, United StatesNo longer taking part

About the trial

What the trial wants to find out

Atrial fibrillation (AF) impacts the lives of 30 million people worldwide. Pulmonary vein isolation (PVI) by catheter ablation is effective for paroxysmal AF, but the success rate remains marginal at 60-80%. For persistent AF, defined as continuous AF that sustains longer than 7 days, the success rate is even lower. The low success rate of AF ablation reflects the fact that there is no effective target identified to modify the underlying substrate beyond PVI. Recently, investigators have made an exciting discovery that higher mean CT attenuation values of peri-atrial fat tissue, correlated with inflammatory fat, are associated with higher incidence of recurrence after AF ablation. In this protocol, investigators will investigate the clinical significance of peri-atrial inflammatory fat tissue in AF using ultra-high resolution CT.

The 3 groups in the trial

  • Arm 1: Paroxysmal AF - PVI armPlacebo, for comparison

    The subjects with paroxysmal AF undergo pulmonary vein isolation (PVI).

    Treatment: Catheter ablation

  • Arm 2: Persistent AF - PVI armPlacebo, for comparison

    The subjects with persistent AF undergo pulmonary vein isolation (PVI).

    Treatment: Catheter ablation

  • Arm 3: Persistent AF - PVI + Fat-targeted ablationTreatment being tested

    The subjects with persistent AF undergo pulmonary vein isolation (PVI) and additional ablation to target the inflammatory fat tissue

    Treatment: Catheter ablation

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Preliminary Studies to Evaluate the Impact of Peri-Atrial Inflammatory Fat Tissue on Atrial Fibrillation Using Ultra-High Resolution CT
Record updated
20 November 2024