NCT02547584

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

4.8 years

First QC Date

September 3, 2015

Last Update Submit

September 9, 2019

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

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

    intraoperative

Secondary Outcomes (6)

  • Correlation of baseline anxiety score with scar severity

    intraoperative

  • Correlation of baseline TWBC and CRP level with the anxiety score

    baseline

  • Change in CAQ score

    12 months

  • Recurrence status

    1 year

  • Change in HAD score

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Group 1: with baseline anxiety+catheter ablation

ACTIVE COMPARATOR

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

Procedure: Catheter ablation

Group 2: Without baseline anxiety + catheter ablation

ACTIVE COMPARATOR

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

Procedure: Catheter ablation

Interventions

Catheter ablationPROCEDURE

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

Also known as: RFCA
Group 1: with baseline anxiety+catheter ablationGroup 2: Without baseline anxiety + catheter ablation

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: ≥ 18 years
  • Sex: female
  • Undergoing catheter ablation for paroxysmal or persistent AF
  • Able and willing to provide written informed consent

You may not qualify if:

  • Receiving behavioral therapy or medications for the anxiety disorder
  • On hormonal supplement
  • On long-term steroid or anti-inflammatory drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Austin, Texas, 78705, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Mitra Mohanty, MD MS FHRS

    Texas Cardiac Arrhythmia Research Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mitra Mohanty, MD MS FHRS

CONTACT

512-544-8198mitra1989@gmail.com

Tamara Metz, RN

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Medical Director

Study Record Dates

First Submitted

September 3, 2015

First Posted

September 11, 2015

Study Start

September 1, 2015

Primary Completion

July 1, 2020

Study Completion

July 1, 2022

Last Updated

September 10, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)