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Impact of Anxiety on Cardiac Substrate Modification in Women With Atrial Fibrillation Undergoing Catheter Ablation (AWARE)

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Catheter ablation
Sponsored by
Texas Cardiac Arrhythmia Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age: ≥ 18 years
  2. Sex: female
  3. Undergoing catheter ablation for paroxysmal or persistent AF
  4. Able and willing to provide written informed consent

Exclusion Criteria:

  1. Receiving behavioral therapy or medications for the anxiety disorder
  2. On hormonal supplement
  3. On long-term steroid or anti-inflammatory drugs

Sites / Locations

  • Texas Cardiac Arrhythmia Institute, St. david's Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1: with baseline anxiety+catheter ablation

Group 2: Without baseline anxiety + catheter ablation

Arm Description

Baseline anxiety will be defined as; Cardiac Anxiety Questionnaire (CAQ) score >2.14 Hospital Anxiety and Depression Questionnaire (HAD) >7 State-Trait Anxiety Inventory (STAI): State-anxiety score >40

Cardiac Anxiety Questionnaire (CAQ) score <2.14 Hospital Anxiety and Depression Questionnaire (HAD) <7 State-Trait Anxiety Inventory (STAI): State-anxiety score <40

Outcomes

Primary Outcome Measures

Correlation between baseline anxiety score and prevalence of left atrial scar and non-pulmonary vein triggers

Secondary Outcome Measures

Correlation of baseline anxiety score with scar severity
Correlation of baseline TWBC and CRP level with the anxiety score
Change in CAQ score
Recurrence status
Recurrence of AF/ AFlutter/ atrial tachycardia off or on anti-arrhythmic drugs
Change in HAD score
Change in State-anxiety

Full Information

First Posted
September 3, 2015
Last Updated
September 9, 2019
Sponsor
Texas Cardiac Arrhythmia Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02547584
Brief Title
Impact of Anxiety on Cardiac Substrate Modification in Women With Atrial Fibrillation Undergoing Catheter Ablation
Acronym
AWARE
Official Title
Impact of Anxiety on Cardiac Substrate Modification in Women With Atrial Fibrillation Undergoing Catheter Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Cardiac Arrhythmia Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This pilot study aims to assess the impact of anxiety on the cardiac substrate remodeling in female patients with paroxysmal and persistent atrial fibrillation (AF).
Detailed Description
Hypothesis: High level of anxiety promotes remodeling of cardiac substrate via persistent inflammation, resulting in an increase in the prevalence of left atrial scar and non-pulmonary vein (non-PV) triggers in women with AF. Rationale: Anxiety is generally defined as a psycho-biological emotional state or reaction that consists of unpleasant feelings of tension, apprehension, nervousness, and worry, and activation of the autonomic nervous system. This disorder is typically more common in women than men. There is considerable evidence to suggest close interactions between anxiety and inflammation and inflammation and AF. Earlier studies have documented strong association between anxiety and inflammation as shown by high levels of inflammatory biomarkers such as C-reactive protein (CRP), total white blood cell (TWBC) count, fibrinogen and interleukin-6 in patients with anxiety. Chronic inflammation results in structural remodeling of the atrial architecture such as fibrotic changes that supports genesis and perpetuation of AF. In cardiac fibrosis, myocytes coupled with fibroblasts can undergo early depolarization resulting in increased ectopic beats and repetitive firing leading to the origin of non-pulmonary vein (non-PV) drivers. Left atrial scar is another known consequence of cardiac fibrosis. Therefore, it is prudent to hypothesize that high level of anxiety for prolonged period results in structural remodeling of cardiac substrates evidenced by increased prevalence of left atrial scar and non-PV triggers in female patients with paroxysmal and persistent AF. Scar and non-PV triggers are known independent predictors of arrhythmia recurrence in AF patients undergoing catheter ablation. Recurrences of AF, despite complete PV disconnection, strongly suggest an important possible role of these foci in serving as a source for the persistence of this arrhythmia. Altered conduction and barriers resulting from the atrial scar form the critical circuits for intra-atrial re-entry that promotes AF persistence. Recent progress in technology and knowledge have provided better understanding and allowed the electrophysiologists to improve on the ablation procedure in order to make it more safe and effective. However, there are still scores of unanswered questions in this relatively young research domain, one of which is if anxiety impacts cardiac substrate remodeling that potentially influences ablation-outcome. Also, of note, anxiety affects how patients perceive their illness, particularly for women, and influence healthcare utilization and economic burden. Therefore, if the role of anxiety would be ascertained, timely intervention of the same would lead to improvement in the success rate of the ablation therapy in females that highly dominate this subset of AF population. Study Design: This pilot study will prospectively enroll 152 consenting female patients undergoing catheter ablation for AF. Eligible patients will be enrolled after signing informed consent, approved by Institutional Review Board of the participating institution.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: with baseline anxiety+catheter ablation
Arm Type
Active Comparator
Arm Description
Baseline anxiety will be defined as; Cardiac Anxiety Questionnaire (CAQ) score >2.14 Hospital Anxiety and Depression Questionnaire (HAD) >7 State-Trait Anxiety Inventory (STAI): State-anxiety score >40
Arm Title
Group 2: Without baseline anxiety + catheter ablation
Arm Type
Active Comparator
Arm Description
Cardiac Anxiety Questionnaire (CAQ) score <2.14 Hospital Anxiety and Depression Questionnaire (HAD) <7 State-Trait Anxiety Inventory (STAI): State-anxiety score <40
Intervention Type
Procedure
Intervention Name(s)
Catheter ablation
Other Intervention Name(s)
RFCA
Intervention Description
Pulmonary vein antrum isolation (PVAI) plus entire posterior wall plus coronary sinus plus left part of the septum. This intervention will be received by all as standard of care
Primary Outcome Measure Information:
Title
Correlation between baseline anxiety score and prevalence of left atrial scar and non-pulmonary vein triggers
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Correlation of baseline anxiety score with scar severity
Time Frame
intraoperative
Title
Correlation of baseline TWBC and CRP level with the anxiety score
Time Frame
baseline
Title
Change in CAQ score
Time Frame
12 months
Title
Recurrence status
Description
Recurrence of AF/ AFlutter/ atrial tachycardia off or on anti-arrhythmic drugs
Time Frame
1 year
Title
Change in HAD score
Time Frame
12 months
Title
Change in State-anxiety
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: ≥ 18 years Sex: female Undergoing catheter ablation for paroxysmal or persistent AF Able and willing to provide written informed consent Exclusion Criteria: Receiving behavioral therapy or medications for the anxiety disorder On hormonal supplement On long-term steroid or anti-inflammatory drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mitra Mohanty, MD MS FHRS
Phone
512-544-8198
Email
mitra1989@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tamara Metz, RN
Phone
512-544-8176
Email
Tamara.Metz@stdavids.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitra Mohanty, MD MS FHRS
Organizational Affiliation
Texas Cardiac Arrhythmia Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Cardiac Arrhythmia Institute, St. david's Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Anxiety on Cardiac Substrate Modification in Women With Atrial Fibrillation Undergoing Catheter Ablation

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