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Dabigatran for Blood Clot Prevention After LAA Closure (DEA-LAA Trial)
DEA-LAA Trial Summary
This trial is designed to see if dabigatran can prevent device-related thrombus (clots) after a Watchman LAA closure device is implanted.
DEA-LAA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DEA-LAA Trial Design
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Who is running the clinical trial?
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- You have had a closure device for a hole in the heart or a prosthetic or mechanical heart valve implanted before.I have not had a major bleeding episode or needed a blood transfusion in the last month.I haven't had any serious GI bleeding in the last month, or it's been treated permanently.My heart's left atrial appendage shape or size doesn't allow for closure device placement.I am over 18 years old.My doctors believe I have more than a year to live.I do not have active bleeding in the brain or elsewhere that needs blood transfusions.You have a known allergy to dabigatran etexilate.I cannot take dabigatran due to side effects, kidney issues, or because I'm on certain medications.I had a heart attack in the last 3 months.I have had a stroke within the last 3 months.You are allergic to aspirin or nickel.I am a pre-menopausal woman not surgically sterile, with my last period within the last year.Your platelet count is less than 50,000 at the time of the Watchman LAAC implantation.You have a high risk of stroke and bleeding, and meet certain criteria for a specific implantation procedure.I had serious bleeding in the past but it's been fixed.I am scheduled for a heart procedure within 3 months after getting a Watchman device.I have an ongoing heart infection.I need long-term blood thinners for a condition that is not atrial fibrillation.I am unable to understand and agree to the study's details on my own.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
- 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.
- Group 1: Treatment arm
Frequently Asked Questions
What is the current enrollment for this experimental protocol?
"This research endeavour is not currently seeking volunteers as it was last modified on June 8th 2022. If you're keen to get involved with medical studies, there are 626 trials looking for people affected by atrial fibrillation and 17 more involving Dabigatran Etexilate Oral Capsules that are open for recruitment."
Are there any slots still available to participate in this research?
"Sadly, this trial is no longer accepting patient applications. It was initially posted on September 1st 2018 and last updated June 8th 2022. Those seeking alternative trials can find 626 studies searching for participants with atrial fibrillation and 17 medical studies recruiting patients to take Dabigatran Etexilate Oral Capsules."
Have there been any other similar experiments conducted before this one?
"Boehringer Ingelheim first tested Dabigatran Etexilate Oral Capsule in 2015 with 40 participants. Following successful results, the drug was granted Phase 4 approval and presently, there are 17 clinical trials occurring across 27 nations encompassing 148 cities."
What potential hazards accompany the ingestion of Dabigatran Etexilate Oral Capsule?
"This drug's efficacy is already established, so it was rated a 3 on our team's scale. Dabigatran Etexilate Oral Capsule has reached Phase 4 of clinical trials and thus been granted approval."
Are there any earlier trials concerning Dabigatran Etexilate Oral Capsule?
"Presently, 17 research studies are in progress for Dabigatran Etexilate Oral Capsule with 3 of them in Phase 3. Although Nashville has a concentration of trials related to this medication, there is an overall pool of 355 sites conducting clinical investigations into the effectiveness and safety of this drug."
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