Recruiting

Observational Study

Sponsor:

Texas Cardiac Arrhythmia Research Foundation

Code:

NCT02547584

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Catheter ablation

Study Details

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).

Conditions

Atrial Fibrillation

Study ID

NCT02547584

Start date

Sep, 2015

Status verified date

Sep, 2019

Completion date

Jul, 2022

Anticipated

Primary completion date

Jul, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

152 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group 1: with baseline anxiety+catheter ablation

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

active comparator: Group 2: Without baseline anxiety + catheter ablation

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

Interventions

Catheter ablation

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

  • Correlation between baseline anxiety score and prevalence of left atrial scar and non-pulmonary vein triggers [ Time Frame: intraoperative ]

Central Contacts and Locations

Central contacts

Mitra Mohanty, MD MS FHRS

512-544-8198mitra1989@gmail.com

Tamara Metz, RN

512-544-8176Tamara.Metz@stdavids.com

Locations

Texas Cardiac Arrhythmia Institute, St. david's Medical Center

Recruiting

Austin, Texas, United States, 78705

More Information

Sponsor

Texas Cardiac Arrhythmia Research Foundation

Last update posted

Sep 10, 2019

Last verified

Sep, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Cardiac Arrhythmia Research Foundation on 2019-09-10.