Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure
Key facts
- Where
- Gdansk, Katowice, Łódź, Lublin, Poznan, Warsaw, Wejherowo, and Zabrze, PolandSee the 10 sites
- Phase
- Phase 4
Where in Poland
- Uniwersyteckie Centrum KliniczneGdansk, PolandNot yet recruiting
- Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W KatowicachKatowice, PolandNot yet recruiting
- SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w ŁodziŁódź, PolandNot yet recruiting
- Uniwersytecki Szpital Kliniczny nr 4 w LublinieLublin, PolandNot yet recruiting
- Uniwersytecki Szpital Kliniczny w PoznaniuPoznan, PolandNot yet recruiting
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut BadawczyWarsaw, PolandNot yet recruiting
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu MedycznegoWarsaw, PolandNot yet recruiting
- Wojskowy Instytut Medyczny Panstwowy Instytut BadawczyWarsaw, PolandNot yet recruiting
- Szpitale Pomorskie Sp. z o.o.Wejherowo, PolandNot yet recruiting
- Śląskie Centrum Chorób Serca w ZabrzuZabrze, PolandNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Institute of Cardiology, Warsaw, Poland
- Trial code
- NCT03445949EU 2024-516382-37-00
- Record updated
- 11 July 2023
- Original description
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 deviceRead full original descriptionShow less
Optimal Antiplatelet Treatment to Achieve Stroke Avoidance and Fall in Bleeding Events Following Left Atrial Appendage Closure (SAFE-LAAC). Comparative Health Effectiveness Randomized Trial - PILOT Study
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
Inclusion: 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 randomized antiplatelet treatment regimen; Participant is willing to sign the study informed consent form.
Exclusion: 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. planned coronary revascularization); Participation in other clinical studies with experimental therapies at the time of enrollment and preceding 3 months; 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 pregnancy test 24 hours prior to randomization if <55 years old) or after surgical sterilization; Known allergy to clopidogrel and/or acetylsalicylic acid precluding its administration as specified by the protocol; Any known inborn or acquired coagulation disorders; Chronic kidney disease stage IV and V; 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); 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.