Peri-Atrial Inflammatory Fat and Atrial Fibrillation

NCT04186169 | Terminated DMC

• 1 other identifier: IRB00210289
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Freedom from any documented episode of AF

  Freedom from any documented episode of AF lasting longer than 30 seconds after the performance of a single ablation procedure without the use of antiarrhythmic drugs (AADs). No episode of AF occurring within the initial 3-month blanking period after ablation will be counted. An episode of AF will be considered part of the primary outcome analyses if it lasts longer than 30 seconds and is documented by any form of monitoring, regardless of symptoms. A repeat left atrial (LA) ablation procedure at any time will also be considered to constitute a recurrence for the purpose of the outcome analyses. Participants who complete fewer than 3 months of follow-up and thus do not complete the blanking period will be excluded from endpoint analysis. There will be no blanking period after a second procedure.

  12 months

Secondary Outcomes (7)

• Freedom from documented AF after two ablation procedures

  12 months

• Freedom from any documented atrial arrhythmia after one ablation procedure

  12 months

• Freedom from any documented atrial arrhythmia after two ablation procedures

  12 months

• Use of antiarrhythmia drugs (AADs)

  12 months

• Procedure time

  12 months

Study Arms (3)

Arm 1: Paroxysmal AF - PVI arm

PLACEBO COMPARATOR

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

Procedure: Catheter ablation

Arm 2: Persistent AF - PVI arm

PLACEBO COMPARATOR

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

Procedure: Catheter ablation

Arm 3: Persistent AF - PVI + Fat-targeted ablation

EXPERIMENTAL

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

Procedure: Catheter ablation

Interventions

Catheter ablation PROCEDURE

Catheter ablation

Arm 1: Paroxysmal AF - PVI arm; Arm 2: Persistent AF - PVI arm; Arm 3: Persistent AF - PVI + Fat-targeted ablation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287-0005, United States

Location

Related Publications (1)

• Ciuffo L, Nguyen H, Marques MD, Aronis KN, Sivasambu B, de Vasconcelos HD, Tao S, Spragg DD, Marine JE, Berger RD, Lima JAC, Calkins H, Ashikaga H. Periatrial Fat Quality Predicts Atrial Fibrillation Ablation Outcome. Circ Cardiovasc Imaging. 2019 Jun;12(6):e008764. doi: 10.1161/CIRCIMAGING.118.008764. Epub 2019 Jun 10.

  PMID: 31177816 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Hiroshi Ashikaga, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Neither the patients nor the operators are NOT blinded as to whether the patients receive the ultra-high resolution CT or the standard CT. For patients with paroxysmal AF, there is no blinding because there is only one group. The patients with persistent AF will be blinded as to whether they are assigned to the PVI group or the PVI + Fat ablation group. The operators are not blinded (single-blinded design).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm 1: Paroxysmal AF (n=100). Observational. Arm 2: Persistent AF (n=50). PVI arm Arm 3: Persistent AF (n=50). PVI + fat-targeted ablation arm

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 4, 2019
• Study Start: February 19, 2021
• Primary Completion: November 12, 2024
• Study Completion: November 12, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)