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Left Atrial Appendage Occlusion vs. NOAC for Atrial Fibrillation (CATALYST Trial)
CATALYST Trial Summary
This trial is looking at whether the Amulet LAA occluder is safe and effective compared to NOAC therapy in patients with non-valvular AF who are at increased risk for ischemic stroke and who have been recommended for long-term NOAC therapy.
CATALYST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCATALYST Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CATALYST Trial Design
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Who is running the clinical trial?
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- I have had blood clots in my veins without a known cause, more than once.You are allergic to any part of the Amulet LAA occluder device, like nickel.My atrial fibrillation is caused by a temporary condition.I don't have conditions like esophageal varices, stricture, or a history of esophageal cancer.I am allergic to or cannot take aspirin, clopidogrel, or blood thinners.I had a heart attack in the last 3 months.I had a procedure to correct heart rhythm issues within the last 60 days.My kidney function is very low but I am not on dialysis.I am at high risk for stroke, with a CHA2DS2-VASc score of 3 or more.I have the most severe form of heart failure.I have been diagnosed with brain artery disease or small vessel disease.My left atrial appendage has been closed or tied off surgically.I have no planned heart surgery or procedures needing sedation within 3 months, except for study-related ones.I have been prescribed a P2Y12 inhibitor for over a year.I have a history of heart valve disease.I had a brief episode of AF triggered by a medical procedure.I have symptoms due to a narrowed artery in my neck, or I've had surgery but the narrowing is less than 50% now.I have not had any surgery or heart procedures in the last 30 days.I am at least 18 years old or at the age of legal consent.I am eligible for long-term blood thinner medication.I have a type of irregular heartbeat not caused by a heart valve issue, confirmed by a heart rhythm test.I can come back for all needed follow-up visits.I have had surgery or a device placed for an atrial septal defect.Your heart's pumping function is very low, according to the most recent check.You have had surgery to fix a hole in your heart or have a device in your heart to close the hole.I need long-term blood thinners for a condition that is not atrial fibrillation.My doctor thinks general anesthesia is risky for me, but it's planned for my procedure.I have an active heart infection or another infection in my blood.I have low platelet count or need transfusions due to low hemoglobin.I can follow the NOAC medication plan if placed in the Control Group.You have a mechanical heart valve.You have a filter in your large vein called the inferior vena cava.I have had a stroke or a mini-stroke in the last 3 months.
- Group 1: Device Group
- Group 2: Control Group
- 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
Are there any other health care facilities conducting the research within city limits?
"Participants can be recruited from Sanford USD Medical Center in Sioux Falls, South dakota, Jackson Heart Clinic in Jackson, Mississippi, and AdventHealth Florida Cardiology - Altamonte Springs in Altamonte Springs, Florida as well as an additional 71 sites."
What medical conditions is the Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder) typically employed to address?
"Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder) is a useful tool for providing vitamin k, supplementing vitamins and administering antibacterial therapy."
Is this research endeavor presently recruiting participants?
"As reflected on clinicaltrials.gov, this scientific investigation is presently looking for volunteers to enroll in the program. The trial was published online on July 7th 2020 and has been revised as of October 27th 2022."
Has the Amplatzer Amulet LAA Occluder been used in other trials to examine Left Atrial Appendage Occlusion?
"The first clinical trial of Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder) occurred in 2017 at CH de Perpignan - Hôpital Saint Jean. Since then, 61 trials have been completed while 9 are still active. Sioux Falls, South dakota has seen a particularly large surge in this type of research."
How many participants are actively involved in this trial?
"This medical trial needs to enroll 2650 volunteers that satisfy the inclusion criteria, with Sanford USD Medical Center in Sioux Falls and Jackson Heart Clinic in Jackson being two of many possible locations."
Does this investigative endeavor break new ground in science?
"There are presently 9 trials in progress for the Amplatzer Amulet LAA Occluder spanning 165 cities and 25 distinct nations. The inaugural study of this medical device, sponsored by Medtronic, was undertaken in 2017 with 170 test subjects; it concluded Phase 4 drug approval that same year. Since then, 61 more experiments have been conducted on Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder)."
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