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Atrial FibrillationAWARENCT02547584

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

A study testing Catheter ablation in people with Atrial Fibrillation, run by Texas Cardiac Arrhythmia Research Foundation at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Atrial Fibrillation
What is being tested?
Catheter ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
1 siteUnited States
Study dates
Sep 2015to Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Mitra Mohanty, MD MS FHRS contact

512-544-8198

mitra1989@gmail.com

United States1 site, 1 recruiting
  • Texas Cardiac Arrhythmia Institute, St. david's Medical Center

    Austin, Texas, 78705

    Recruiting

Other trials in United States

About this study

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).

Read the 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.

Being tested
Catheter ablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Catheter ablationProcedure or surgery

    Also called RFCA

    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

Study groups in NCT02547584
Study groupRoleWhat they receive
Group 1: with baseline anxiety+catheter ablationActive comparatorBaseline 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
Receives: Procedure: Catheter ablation
Group 2: Without baseline anxiety + catheter ablationActive comparatorCardiac Anxiety Questionnaire (CAQ) score <2.14 Hospital Anxiety and Depression Questionnaire (HAD) <7 State-Trait Anxiety Inventory (STAI): State-anxiety score <40
Receives: Procedure: Catheter ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: intraoperative

Secondary outcomes (6)
  1. Correlation of baseline anxiety score with scar severity

    Measured: intraoperative

  2. Correlation of baseline TWBC and CRP level with the anxiety score

    Measured: baseline

  3. Change in CAQ score

    Measured: 12 months

  4. Recurrence status

    Recurrence of AF/ AFlutter/ atrial tachycardia off or on anti-arrhythmic drugs

    Measured: 1 year

  5. Change in HAD score

    Measured: 12 months

  6. Change in State-anxiety

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionJul 2020 (estimated)
  4. Study completionJul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
152 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02547584
Sponsor's protocol ID
TCAI_AWARE
Acronym
AWARE
Status last verified
Sep 2019
First submitted
3 Sep 2015
Last updated
10 Sep 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Catheter ablation in people with Atrial Fibrillation, run by Texas Cardiac Arrhythmia Research Foundation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mitra Mohanty, MD MS FHRS (512-544-8198, mitra1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between baseline anxiety score and prevalence of left atrial scar and non-pulmonary vein triggers (time frame: intraoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.

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