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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 belowSelect...
I am 18 years old or older.
Select...
I have symptoms of atrial fibrillation.
Select...
I have been diagnosed with paroxysmal atrial fibrillation.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have atrial fibrillation but no symptoms.
Select...
I have significant memory or thinking problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
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.
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,655,241 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have atrial fibrillation but no symptoms.I have symptoms of atrial fibrillation.I have an appointment at NYP to talk about a procedure to treat heart rhythm problems.I have been diagnosed with paroxysmal atrial fibrillation.You have a serious mental illness.I have significant memory or thinking problems.
Research Study Groups:
This trial has the following groups:- Group 1: Shared decision-making tool
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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