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Amplatzer Amulet LAAO vs. NOAC

Study acronym: CATALYST
StatusActive, Not Recruiting
PhaseNot applicable
Started2020-07-07
View on ClinicalTrials.gov ↗

Amendment history

2026-02-06
Recruiting→Active, Not Recruiting Study Status, Oversight, Contacts/Locations v35
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2027-08→2029-01
Completion date2030-08→2031-04
Study sites132→127
2025-02-25
Study Identification, Study Status, Contacts/Locations v34
Study sitesdetails revised at 110 of 132 sites
Study titlerevised
Amplatzer Amulet LAAO Vsvs. NOAC
2025-01-30
Study Identification, Study Status, Oversight, Contacts/Locations v33
Study sites132 entries, revised
CardiovascularVia ResearchChristi InstituteRegional Medical Center - St. Francis Campus Our Lady of Kansas Louisianathe CardiologyLake AssociatesPhysician Group
Study titlerevised
Amplatzer Amulet LAAO vsVs. NOAC
2025-01-08
Study Status, Contacts/Locations v32
Study sites132 entries, revised
Tokyo Medical and Dental University HospitalInstitute of MedicineScience Tokyo Hospital
2024-08-27
Study Status, Contacts/Locations v31
Study sitesdetails revised at 13 of 132 sites
Show 30 earlier versions
2024-07-17
Study Status, Contacts/Locations v30
Study sites128→132
2024-07-03
Study Status, Contacts/Locations v29
Study sites127→128
2024-06-23
Study Status, Contacts/Locations v28
Study sitesdetails revised at 11 of 127 sites
2024-04-15
Study Status, Eligibility, Contacts/Locations v27
Primary completion date2024-12→2027-08
Completion date2029-04→2030-08
Study sites126→127
Eligibility criteria+26 characters
[...] or systemic embolism, defined as a CHA2DS2-VASc score of ≥ 2 for men and ≥ 3 for women Eligible for long-term NOAC therapy Able to comply with the [...]
2024-01-11
Study Status, Contacts/Locations v26
Study sites123→126
2023-09-11
Study Status, Contacts/Locations v25
Study sites121→123
2023-07-26
Study Status, Contacts/Locations v24
Study sites119→121
2023-05-11
Study Status, Contacts/Locations v23
Study sites116→119
2023-02-24
Study Status, Contacts/Locations v22
Study sites115→116
2023-01-12
Study Status, Contacts/Locations v21
Study sites108→115
2022-10-27
Study Status, Contacts/Locations v20
Study sites105→108
2022-09-09
Study Status, Contacts/Locations v19
Study sites103→105
2022-07-11
Study Status, Contacts/Locations v18
Study sites102→103
2022-06-13
Study Status, Contacts/Locations v17
Study sites99→102
2022-04-13
Study Status, Contacts/Locations v16
Study sites98→99
2022-02-23
Study Status, Contacts/Locations v15
Study sites90→98
2021-11-09
Study Status, Contacts/Locations v14
Study sites85→90
2021-10-08
Study Status, Contacts/Locations v13
Study sites74→85
2021-09-17
Study Status, Contacts/Locations v12
Study sites60→74
2021-06-04
Study Status, Contacts/Locations v11
Study sites55→60
2021-04-19
Study Status, Contacts/Locations v10
Study sites47→55
2021-02-27
Study Status, Contacts/Locations v9
Study sites37→47
2021-01-12
Study Status, Contacts/Locations v8
Study sites13→37
2020-09-21
Study Status, Contacts/Locations v7
Study sites7→13
2020-09-15
Study Status, Contacts/Locations v6
Study sites4→7
2020-08-12
Study Status, Contacts/Locations v5
Study sites2→4
2020-08-03
Study Status, Outcome Measures, Eligibility, Contacts/Locations v4
Start dateestimated 2020-07→confirmed 2020-07-07
Study sites1→2
Eligibility criteria+99 characters
[...] m OAC therapy for a condition other than AF Planned cardiac procedureintervention or surgery, which is invasive or requires sedation or anesthesia, within 3 months offollowing randomization, (other than study-related procedures such as LAAO and cardiac imaging (if applicable)) Known contraindication to, or allergic to, aspirin, clopidogrel, or OAC medication use Indicated for chronic P2Y12 platelet inhibitor for >1 year post-randomization In the opinion of the investigator, is considered at high r [...] ntervention or surgery within 30 days prior to randomization, Underwent catheter ablation for AF o [...] [...]
Secondary endpoints3 entries, revised
SecondaryMajor Endpoint #1 (composite event) Secondary Endpoint #2 (device or procedure related complication) Secondary Endpoint #3 (bleeding or CRNMB events) Major bleeding or CRNMB events Disabling or fatal strokes
Primary endpoints3 entries, revised
PrimaryComposite Endpointof #1ischemic stroke or systemic embolism Composite of ischemic stroke, systemic embolism, or cardiovascular (CompositeCV) event)mortality PrimaryMajor Endpoint #2A (bleeding) Primary Endpoint #2B (bleeding or clinically relevant non-major bleeding (CRNMB) events), excluding procedure related events
2020-07-14
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2020-07-02
Study Status v2
Start date2020-03→2020-07
2020-01-13
Study Status v1
Re-verified, no change to tracked fields
2020-01-10
Original filing
The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion.
Trial Details
NCT Number NCT04226547
Lead Sponsor Abbott Medical Devices
Conditions Atrial Fibrillation, Stroke, Bleeding
Enrollment 2,650 participants
Start Date 2020-07-07
Primary Completion 2029-01 (estimated)
Study Completion 2031-04 (estimated)
Updated on ClinicalTrials.gov 2026-02-10