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Antiarrhythmic Drugs for Atrial Fibrillation
Study Summary
This trial will enroll patients with frequent episodes of atrial fibrillation in a study testing two different classes of anti arrhythmic drugs. This study will provide preliminary data for a larger study testing the hypothesis that a common AF genetic risk allele modulates response to different AADs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- My atrial fibrillation is caused by a treatable condition like hyperthyroidism.I am 18 years old or older.I have had two or more episodes of AFib each month.I have tried two or more antiarrhythmic drugs for atrial fibrillation.I can take both Flecainide and Sotalol medications.I have been diagnosed with permanent atrial fibrillation or isolated atrial flutter.Your recent heart test shows atrial fibrillation.I have used amiodarone only for a short time in the hospital.I have had a procedure to correct atrial fibrillation.Your kidneys are not working well enough to filter waste from your blood.I cannot take certain heart medications due to a heart condition or past heart attack.I cannot take certain heart medications due to a long QT interval.You have a serious problem with your heart's electrical system, unless you have a pacemaker.Your heart's pumping ability is less than 50%.I am not pregnant or nursing.People of African, European, and Hispanic backgroundYou have a medical condition that is expected to cause death within a year.I have not had heart or chest surgery in the last 6 months.
- Group 1: sotalol 1st
- Group 2: flecainide 1st
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
How does the safety profile of flecainide compare to other treatments?
"Flecainide has an assigned safety rating of 3, since it is already approved for use in Phase 4 trials."
What prior investigations have been implemented using flecainide as a primary catalyst?
"Presently, 9 trials of flecainide 1st are in progress. One is currently entering Phase 3 while the remaining studies are being administered at 61 sites located primarily within New york City."
What ailments are typically addressed with flecainide?
"Flecainide 1st is the primary treatment for severe paroxysmal atrial fibrillation and it has also been used to alleviate other ailments such as paroxysmal supraventricular tachycardia, sinus rhythm, and ventricular tachycardia."
To what extent is the population being examined in this exploration?
"Affirmative. Clinicaltrials.gov data suggests that this clinical trial is presently pursuing participants, which were initially posted on December 31st 2020 and edited for the last time June 23rd 2022. 162 individuals are needed to be recruited from 4 different medical facilities."
Does this trial have any conditions for participation?
"To be eligible for this research, participants must have atrial fibrillation and meet the age requirements (18-100). Furthermore, only individuals of African, European or Hispanic descent can join. A total of 162 patients are being recruited."
Are opportunities to participate in this research study still available?
"Affirmative. According to the clinicaltrials.gov listing, this clinical study is currently open for enrollment with a start date of December 31st 2020 and an end date of June 23rd 2022. This medical trial requires 162 participants from 4 separate sites."
Is eligibility for this medical experiment limited to adults only?
"The upper age limit set by this clinical trial is 100, while the lower limit stands at 18. For those under 18, 12 trials are currently available and 481 for individuals aged over 65."
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