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Study Summary
This trial will evaluate the EPi-Sense® Guided Coagulation System for the treatment of patients with long-standing persistent atrial fibrillation who are refractory or intolerant to at least one Class I and/or III AAD.
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?
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- I have Barrett's esophagus.I have had pericarditis before.I am legally able to make my own decisions.I have had atrial fibrillation for more than a year.I have not responded to or cannot tolerate at least one type of heart rhythm medication.I need surgery for heart valve repair, bypass, or to close a hole in my heart.I do not have an active infection or sepsis.I am between 18 and 79 years old.I cannot take blood thinners like heparin or coumadin.I have had more than 2 catheter ablations for atrial fibrillation, focusing only on the pulmonary veins.I have had a stroke in the past, but not a minor one that fully resolved.I have ulcers, strictures, or varices in my esophagus.I have a blockage in one or more of my lung veins.I am being treated for irregular heartbeats from the lower chambers of my heart.My kidney function is low but I am not on dialysis.I am scheduled for a heart procedure to manage the left atrial appendage.I do not have any health conditions that would limit my life to under a year.I have had heart surgery in the past.I have a blood clot in my heart's left chamber found during surgery.
- Group 1: Hybrid Convergent
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 many people fit the profile to be included in this experiment?
"The most recent information on clinicaltrials.gov reveals that this trial is still looking for patients. The posting date was April 13th, 2022 and the last update was September 14th, 2022. There is space for 325 individuals at 4 different sites."
What is the main focus of this clinical trial?
"The primary outcome of this study, which will be observed over a 30-day period post-procedure, is the freedom from atrial fibrillation (AF), atrial flutter (AFL), and atrial tachycardia (AT) for greater than 30 seconds in 12 months without the need for a new or increased dose of class I/III antiarrhythmic drugs (AADs). Additionally, this trial will measure secondary outcomes including freedom from AF/AT/AFL >30 seconds with previously failed or intolerable class I/III AADs, which is defined as freedom from AF/AT"
How many research institutions are testing this hypothesis?
"There are 4 locations recruiting patients for this clinical trial. The sites are MedStar Union Memorial Hospital in Baltimore, Emory Saint Joseph Hopsital in Atlanta, and Baycare Health Systems in Clearwater. There are also other recruiting sites located elsewhere."
Are there any unfilled participant positions in this experiment?
"This clinical trial, as indicated by its listing on clinicaltrials.gov, is actively recruiting patients. The trial was originally posted on April 13th, 2022 and was most recently updated on September 14th, 2022."
Are octogenarians welcome in this trial?
"Participants must be between 18-80 years old to take part in this experiment."
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