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Impact of Peri-Atrial Inflammatory Fat Tissue on Atrial Fibrillation Using Ultra-High Resolution CT

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ClinicalTrials.gov Identifier: NCT04186169
Recruitment Status : Not yet recruiting
First Posted : December 4, 2019
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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 (Ciuffo at el., Circ Cardiovasc Imaging 2019;12:e008764). In this protocol, investigators will investigate the clinical significance of peri-atrial inflammatory fat tissue in AF using ultra-high resolution CT.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Catheter ablation Not Applicable

Detailed Description:

This protocol entails preliminary studies to demonstrate feasibility and inform effect size, sample size and power estimates for future studies designed to test the efficacy of inflammatory fat-targeted ablation in a larger prospective randomized study.

Investigators will prospectively enroll 300 patients referred to the Johns Hopkins Hospital for catheter ablation of AF, consisting of patients with paroxysmal AF (n=100), persistent AF (n=100) and recurrent AF/AFL post-AF ablation (n=100) (Figure 3). All the patients will undergo pre-procedural CT using the ultra-high resolution CT scanner. If the ultra-high resolution CT is not available on the day of the CT scan, the patient may instead undergo pre-procedural CT using a standard CT scanner. The CT protocol will be the standard prospectively-gated CT scan to minimize radiation exposure to the patient. No functional information is needed. Compared with the standard CT scanner, the ultra-high resolution CT is expected to provide finer details of inflammatory fat structure and distribution over the per-atrium.

The patients with paroxysmal AF will receive the standard of care, which is PVI, and the clinical outcome will be followed up to 12 months post-procedure. For the patients with persistent AF and recurrent AF/ Atrial Flutter (AFL), there is no standard of care as to how to perform ablation beyond repeating PVI. In an attempt to reduce the likelihood of recurrence, most electrophysiologists combine PVI with additional empiric ablation strategies to modify the underlying arrhythmic substrate, such as linear lesions (e.g. roof lines, mitral isthmus lines), focal ablation to eliminate complex fractionated atrial electrograms (CFAE) and rotating drivers. Nevertheless, prospective randomized studies demonstrate that these empiric ablation strategies do not improve clinical outcomes compared with PVI alone. In this protocol, the patients with persistent AF and recurrent AF/AFL will be randomly split into two groups: 1) PVI group, and 2) PVI + fat ablation group, where additional ablation is performed to target the inflammatory fat tissue. The clinical outcome will be followed up to 12 months post-procedure.

In all the patients, two sets of blood specimens (total <20 mL) will be collected at the time of the procedure: one set is from the peripheral venous blood, and the other from the coronary sinus blood. Those samples will be sent to quantify the fat and inflammatory biomarkers (e.g. adipokines, cytokines, high-sensitivity troponin T [hsTnT]) to evaluate the local and systemic effect of inflammation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 Arm 4: Recurrent AF/AFL (n=50). PVI arm Arm 5: Recurrent AF/AFL (n=50). PVI + fat-targeted ablation arm
Masking: Single (Participant)
Masking Description: 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 and recurrent AF/AFL 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).
Primary Purpose: Treatment
Official Title: Preliminary Studies to Evaluate the Impact of Peri-Atrial Inflammatory Fat Tissue on Atrial Fibrillation Using Ultra-High Resolution CT
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Persistent AF - PVI arm
The subjects with persistent AF undergo pulmonary vein isolation (PVI).
Procedure: Catheter ablation
Catheter ablation

Experimental: Persistent AF - PVI + Fat-targeted ablation
The subjects with persistent AF undergo pulmonary vein isolation (PVI) and additional ablation to target the inflammatory fat tissue
Procedure: Catheter ablation
Catheter ablation

Sham Comparator: Recurrent AF/AFL - PVI arm
The subjects with recurrent AF/AFL undergo pulmonary vein isolation (PVI).
Procedure: Catheter ablation
Catheter ablation

Experimental: Recurrent AF/AFL - PVI + Fat-targeted ablation
The subjects with recurrent AF/AFL undergo pulmonary vein isolation (PVI) and additional ablation to target the inflammatory fat tissue.
Procedure: Catheter ablation
Catheter ablation

Sham Comparator: Paroxysmal AF - PVI arm
The subjects with paroxysmal AF undergo pulmonary vein isolation (PVI).
Procedure: Catheter ablation
Catheter ablation




Primary Outcome Measures :
  1. Recurrence [ Time Frame: 12 months ]
    Recurrence of AF, defined as >30 sec of sustained AF episode documented in a 24-hour Holter monitor at 12 months after the index ablation procedure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (>18 years old) undergoing mapping and ablation of AF for whom cardiac CT is clinically indicated to guide the procedure as a standard of care.

Exclusion Criteria:

  • Inability to provide consent; or
  • Glomerular Filtration Rate (eGFR)<30 mL/min/1.73 m2.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04186169


Contacts
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Contact: Hiroshi Ashikaga, MD, PhD 4106146076 hashika1@jhmi.edu

Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Hiroshi Ashikaga, MD, PhD Johns Hopkins University

Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04186169    
Other Study ID Numbers: IRB00210289
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes