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Decision Aid Tool for Atrial Fibrillation

N/A
Recruiting
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years and older
Symptomatic AF at baseline
Must not have
Asymptomatic AF
Severe cognitive impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a decision aid visualization tool can help patients make informed decisions about ablation surgery with low levels of regret or conflict.

Who is the study for?
This trial is for English-speaking adults over 18 with symptomatic, paroxysmal atrial fibrillation who are considering catheter ablation at NewYork-Presbyterian Hospital. They must be able to give informed consent. Those with terminal illnesses, asymptomatic AF, major psychiatric conditions or severe cognitive impairment cannot participate.
What is being tested?
The study tests a shared decision-making tool that uses visual aids to show common symptoms after heart rhythm surgery (ablation). It aims to see if this helps patients make decisions about their treatment and measures how satisfied they are with those decisions.
What are the potential side effects?
Since the intervention is a decision-making tool rather than a medical treatment, there are no direct physical side effects expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
Select...
I have symptoms of atrial fibrillation.
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I have been diagnosed with paroxysmal atrial fibrillation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have atrial fibrillation but no symptoms.
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I have significant memory or thinking problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Decision regret assessed using the Decisional Regret Scale
Decision satisfaction assessed using the Satisfaction with Decision Scale
Decisional conflict assessed using the Decisional Conflict Scale
Secondary study objectives
Post-ablation health-related quality of life assessed using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire
Post-ablation symptom burden assessed using the Atrial Fibrillation severity Scale (AFSS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Shared decision-making toolExperimental Treatment1 Intervention
Participants in this arm will view a shared decision-making tool while they are undergoing consultation to have an atrial fibrillation ablation.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,655,177 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
264 Patients Enrolled for Atrial Fibrillation
National Institute of Nursing Research (NINR)NIH
600 Previous Clinical Trials
10,377,698 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
1,084 Previous Clinical Trials
1,138,824 Total Patients Enrolled
6 Trials studying Atrial Fibrillation
1,819 Patients Enrolled for Atrial Fibrillation

Media Library

Shared decision-making tool Clinical Trial Eligibility Overview. Trial Name: NCT04993807 — N/A
Atrial Fibrillation Research Study Groups: Shared decision-making tool
Atrial Fibrillation Clinical Trial 2023: Shared decision-making tool Highlights & Side Effects. Trial Name: NCT04993807 — N/A
Shared decision-making tool 2023 Treatment Timeline for Medical Study. Trial Name: NCT04993807 — N/A
~8 spots leftby Jan 2025
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