Left Atrial Appendage Occlusion Clinical Trial
— ARMYDA-AMULETOfficial title:
Head-to-head Comparison of Single Versus Dual Antiplatelet Treatment Strategy After Percutaneous Left Atrial Appendage Closure: a Multicenter, Randomized Study - ARMYDA-AMULET
The study will perform a randomized, head-to-head comparison between SAPT (aspirin) and DAPT (aspirin plus clopidogrel) after percutaneous LAA closure with implantation of the Amulet device (AbbottTM, Abbott Park, Illinois, US) in patients with AF. Primary outcome measure will be a net composite endpoint at 6 months including all-cause death, DRT, clinically relevant bleeding complications and ischemic events. The SAPT arm will receive aspirin alone up to 6 months, while the DAPT arm will receive DAPT for 3 months and then aspirin alone. Thus, between 3- and 6-month follow-up both groups will be given aspirin alone.
Status | Recruiting |
Enrollment | 574 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Men or women aged =18 years signing a specific informed consent - Patients with a planned percutaneous LAA closure; - Patients with documented non-valvular AF, irrespective of the type (paroxysmal, permanent, persistent), and CHA2DS2-VASc score =2 - Patients suitable for treatment with aspirin and clopidogrel according to the Summaries of product characteristics (SmPCs); - Patients considered unsuitable for long-term oral anticoagulant therapy due to a high bleeding risk. Patients will be judged unsuitable for anticoagulation because of bleeding-prone comorbidities, history of previous bleeding (with or without anticoagulant treatment) or an expected low adherence to therapy. - Patient's availability to undergo the follow-up visits scheduled for the study - Negative pregnancy testing (if applicable), performed at the time of enrollment. Exclusion Criteria: - CHADS-VAsc score 0-1 - Requirement for on-going therapy with clopidogrel at the time of screening evaluation (e.g. current therapy with clopidogrel at the time of the screening evaluation will be an exclusion criterion) - Known hypersensitivity to the study drugs (aspirin or clopidogrel) - Patients deemed to be unsuitable for at least 6 months antiplatelet therapy (SAPT or DAPT) because of a recent (<1 month) major bleeding event - Planned oral anticoagulant therapy after the procedure - Moderate to severe mitral stenosis - Mechanical heart prosthetic valve - Active endocarditis - Active bleeding - Myocardial infarction or percutaneous coronary intervention <6 months - Major surgery within one month - Intracranial neoplasm, aneurysm or arterio-venous malformation - Platelet count <50,000/µL - Recent stroke (<1 month) - Fibrinolytic therapy within 10 days - Baseline hemoglobin <9 g/dL - Pregnant woman - Breast-feeding - Women unavailable to use contraception during the study period |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G. Rodolico | Catania | |
Italy | Presidi Ospedalieri Riuniti ASL 6 Ciriè - Presidio Ospedaliero Riunito Sede di Ciriè | Ciriè | |
Italy | Azienda Ospedaliera Universitaria Careggi | Firenze | |
Italy | ASST Grande Ospedale Metropolitano Niguarda | Milano | |
Italy | Centro Cardiologico Fondazione Monzino | Milano | |
Italy | Azienda Ospedaliera dei Colli Monaldi | Napoli | |
Italy | Azienda Ospedaliera Universitaria Federico II | Napoli | |
Italy | Ospedale Maggiore della Carità | Novara | |
Italy | Clinica San Carlo | Paderno Dugnano | |
Italy | Azienda Ospedaliero-Universitaria di Parma | Parma | |
Italy | Policlinico San Matteo | Pavia | |
Italy | Ospedale del Cuore G. Pasquinucci | Pisa | |
Italy | Ospedale di Rivoli | Rivoli | |
Italy | Ospedale S. Eugenio - ASL Roma 2 | Roma | |
Italy | Azienda Ospedaliera Universitaria Sassari | Sassari | |
Italy | Ospedale Mauriziano Umberto I | Torino | |
Italy | Ospedale San Giovanni Bosco | Torino | |
Italy | Villa Maria Pia Hospital | Torino | |
Italy | Ospedale Sant'Andrea | Vercelli |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero Universitaria Maggiore della Carita | Abbott Medical Devices |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary endpoint:all-cause death, DRT (at 3- or 6-month TEE), ischemic stroke, systemic embolic events (SEE) or BARC classification bleeding =3. | Primary endpoint will be the 6-month incidence in the two arms (SAPT versus DAPT) of the net composite endpoint including all-cause death, DRT (at 3- or 6-month TEE), ischemic stroke, systemic embolic events (SEE) or BARC classification bleeding =3. An independent board for clinical event adjudication and data safety monitoring will be created. | 6 months | |
Secondary | Secondary endpoint: Device-related thrombosis | Device-related thrombosis evaluated with transesophageal echocardiogram | At 3 months and at 6 months | |
Secondary | Secondary endpoint: Any-cause death | Any-cause death | 6 months | |
Secondary | Secondary endpoint: ischemic stroke or systemic embolic events | Incidence of ischemic stroke or systemic embolic events (SEE) | At 3 months and at 6 months | |
Secondary | Secondary endpoint: Any bleeding | Incidence of any bleeding | At 3 months and at 6 months | |
Secondary | Secondary endpoint: BARC =3 bleeding | Incidence of BARC classification bleeding =3 | At 3 months and at 6 months |
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