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Procedure
Group 1: with baseline anxiety+catheter ablation for Atrial Fibrillation (AWARE Trial)
N/A
Waitlist Available
Led By Mitra Mohanty, MD MS FHRS
Research Sponsored by Texas Cardiac Arrhythmia Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
AWARE Trial Summary
This trial will study how anxiety affects heart health in women with different types of irregular heartbeats.
AWARE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Correlation between baseline anxiety score and prevalence of left atrial scar and non-pulmonary vein triggers
Secondary outcome measures
Change in CAQ score
Change in HAD score
Change in State-anxiety
+3 moreAWARE Trial Design
2Treatment groups
Active Control
Group I: Group 1: with baseline anxiety+catheter ablationActive Control1 Intervention
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
Group II: Group 2: Without baseline anxiety + catheter ablationActive Control1 Intervention
Cardiac Anxiety Questionnaire (CAQ) score <2.14 Hospital Anxiety and Depression Questionnaire (HAD) <7 State-Trait Anxiety Inventory (STAI): State-anxiety score <40
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Who is running the clinical trial?
Texas Cardiac Arrhythmia Research FoundationLead Sponsor
37 Previous Clinical Trials
13,228 Total Patients Enrolled
26 Trials studying Atrial Fibrillation
6,493 Patients Enrolled for Atrial Fibrillation
Mitra Mohanty, MD MS FHRSPrincipal InvestigatorTexas Cardiac Arrhythmia Research Foundation
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