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New treatment option for Atrial Fibrillation
Official title Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure
ClinicalTrials.gov ID: NCT03445949
What this study is testing
What is short postimplantation dual antiplatelet therapy?
short postimplantation dual antiplatelet therapy is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for atrial fibrillation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- SAFE-LAAC Trial has been designed to gather data on the most optimal strategy of antiplatelet therapy after transcatheter left atrial appendage occlusion with Amplatzer or WATCHMAN device
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Successful left atrial appendage occlusion with Amplatzer or WATCHMAN device within 37 days before randomization
- Treatment with dual antiplatelet therapy (clopidogrel and acetylsalicylic acid) between left atrial appendage closure and randomization
- Participant's age 18 years or older at the time of signing the informed consent form
- Participant is willing to follow all study procedures; especially the assigned by chance antiplatelet treatment regimen
- Participant is willing to sign the study informed consent form
You likely can't join if
- Indications to dual antiplatelet therapy other than atrial fibrillation and/or left atrial appendage occlusion at the time of enrollment or predicted...
- Indications to anticoagulation at the time of enrollment and/or predicted appearance of such indications within the duration of the trial (e.g...
- Known allergy to clopidogrel and/or acetylsalicylic acid precluding its administration as specified by the protocol
- Any known inborn or acquired coagulation disorders
- Peridevice leak \>5mm on imaging study preceding enrollment
- Left atrial thrombus on an imaging study performed after successful left atrial appendage closure but before enrollment
See the full eligibility criteria
- Successful left atrial appendage occlusion with Amplatzer or WATCHMAN device within 37 days before randomization
- Treatment with dual antiplatelet therapy (clopidogrel and acetylsalicylic acid) between left atrial appendage closure and randomization
- Participant's age 18 years or older at the time of signing the informed consent form
- Participant is willing to follow all study procedures; especially the assigned by chance antiplatelet treatment regimen
- Participant is willing to sign the study informed consent form
- Indications to dual antiplatelet therapy other than atrial fibrillation and/or left atrial appendage occlusion at the time of enrollment or predicted appearance of such indications within the duration of the trial (e.g...
- Indications to anticoagulation at the time of enrollment and/or predicted appearance of such indications within the duration of the trial (e.g. pulmonary embolism)
- Known allergy to clopidogrel and/or acetylsalicylic acid precluding its administration as specified by the protocol
- Any known inborn or acquired coagulation disorders
- Peridevice leak \>5mm on imaging study preceding enrollment
- Left atrial thrombus on an imaging study performed after successful left atrial appendage closure but before enrollment
- Life expectancy of fewer than 18 months
- Participation in other clinical studies with experimental therapies at the time of enrollment and preceding 3 months
- Chronic kidney disease stage IV and V
- Women who are pregnant or breastfeeding; women of childbearing potential who do not consent to apply at least two methods of contraception. This criterion does not apply to women 2 years post menopause (with negative...
The study team makes the final eligibility decision.
Where it's taking place
- Warsaw, Masovian Voivodeship, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Warsaw, Masovian Voivodeship, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.