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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

Tracking Information
First Submitted Date  ICMJE December 2, 2019
First Posted Date  ICMJE December 4, 2019
Last Update Posted Date February 17, 2020
Estimated Study Start Date  ICMJE March 1, 2020
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04186169 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Peri-Atrial Inflammatory Fat Tissue on Atrial Fibrillation Using Ultra-High Resolution CT
Official Title  ICMJE Preliminary Studies to Evaluate the Impact of Peri-Atrial Inflammatory Fat Tissue on Atrial Fibrillation Using Ultra-High Resolution CT
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE Procedure: Catheter ablation
Catheter ablation
Study Arms  ICMJE
  • Sham Comparator: Persistent AF - PVI arm
    The subjects with persistent AF undergo pulmonary vein isolation (PVI).
    Intervention: Procedure: 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
    Intervention: Procedure: Catheter ablation
  • Sham Comparator: Recurrent AF/AFL - PVI arm
    The subjects with recurrent AF/AFL undergo pulmonary vein isolation (PVI).
    Intervention: Procedure: 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.
    Intervention: Procedure: Catheter ablation
  • Sham Comparator: Paroxysmal AF - PVI arm
    The subjects with paroxysmal AF undergo pulmonary vein isolation (PVI).
    Intervention: Procedure: Catheter ablation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 2, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hiroshi Ashikaga, MD, PhD 4106146076 hashika1@jhmi.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04186169
Other Study ID Numbers  ICMJE IRB00210289
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hiroshi Ashikaga, MD, PhD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP