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