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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04226547




Registration number
NCT04226547
Ethics application status
Date submitted
9/01/2020
Date registered
13/01/2020
Date last updated
28/08/2024

Titles & IDs
Public title
Amplatzer Amulet LAAO vs. NOAC
Scientific title
Clinical Trial of Atrial Fibrillation Patients Comparing Left Atrial Appendage Occlusion Therapy to Non-vitamin K Antagonist Oral Anticoagulants
Secondary ID [1] 0 0
10310
Universal Trial Number (UTN)
Trial acronym
CATALYST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Stroke 0 0
Bleeding 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder)
Treatment: Drugs - Non-Vitamin K Oral Antagonists

Experimental: Device Group - Randomized to Amplatzer Amulet LAA occluder

Active comparator: Control Group - Randomized to NOAC


Treatment: Devices: Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder)
Implantation of an Amplatzer Amulet left atrial appendage occluder

Treatment: Drugs: Non-Vitamin K Oral Antagonists
Initiation or continuation of a NOAC drug
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of ischemic stroke, systemic embolism, or cardiovascular (CV) mortality
Timepoint [1] 0 0
2 years
Primary outcome [2] 0 0
Major bleeding or clinically relevant non-major bleeding (CRNMB) events, excluding procedure related events
Timepoint [2] 0 0
2 years
Primary outcome [3] 0 0
Composite of ischemic stroke or systemic embolism
Timepoint [3] 0 0
3 years
Secondary outcome [1] 0 0
Major bleeding or CRNMB events
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Major bleeding or CRNMB events
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Disabling or fatal strokes
Timepoint [3] 0 0
2 years

Eligibility
Key inclusion criteria
* Documented paroxysmal, persistent, or permanent non-valvular AF (documentation must include an electrocardiogram, Holter, or event recorder)
* At high risk of stroke 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 required NOAC medication regimen if randomized to the Control Group
* Able to comply with the required medication regimen post-device implant if subject is randomized to the Device Group or subject is a Roll-in
* Able to understand, and is willing to provide, written informed consent to participate in the trial, prior to any clinical investigation related procedure or assessment
* 18 years of age or older, or the age of legal consent
* Able and willing to return for required follow-up visits and assessments
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Requires long-term OAC therapy for a condition other than AF
* Planned cardiac intervention or surgery, which is invasive or requires sedation or anesthesia, within 3 months following 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 P2Y12 platelet inhibitor for >1 year post-randomization
* In the opinion of the investigator, is considered at high risk for general anesthesia and general anesthesia is planned for the study procedure
* Has undergone atrial septal defect (ASD) repair or has an ASD closure device present
* Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted
* Is implanted with a mechanical valve prosthesis
* Is implanted with an inferior vena cava filter
* History of rheumatic or congenital mitral valve heart disease
* Has any of the customary contraindications for a percutaneous catheterization procedure (e.g. subject is too small to accommodate the ICE probe (if planned) or required catheters, or subject has active infection or bleeding disorder)
* Customary contraindications for TEE/TOE (e.g., presence of esophageal varices, esophageal stricture, or history of esophageal cancer)
* Experienced stroke or transient ischemic attack (TIA) within 90 days prior to randomization or implant procedure (as applicable)
* Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to randomization
* Underwent catheter ablation for AF or atrial flutter within 60 days prior to randomization
* Experienced myocardial infarction within 90 days prior to randomization
* New York Heart Association Class IV Congestive Heart Failure
* Left ventricular ejection fraction = 30% (per most recent assessment)
* Symptomatic carotid disease (defined as > 50% lumen diameter narrowing on CTA, MRA, or TCD with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is < 50% lumen diameter narrowing
* Has known intracranial atherosclerosis and/or intracranial small vessel disease (defined as 6 points on the Fazekas Scale)
* Reversible cause of AF (i.e., secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
* History of idiopathic or recurrent venous thromboembolism
* LAA is obliterated or surgically ligated
* Thrombocytopenia (defined as < 50,000 platelets per microliter (<50 x 10^9 /L)or anemia (defined as hemoglobin < 10 g/dL) requiring transfusions
* Hypersensitivity to any portion of the device material or individual components of the Amulet LAA occluder device (e.g., nickel allergy)
* Actively enrolled in, or plans to enroll in, a concurrent clinical study in which the active treatment arm may confound the results of this trial
* Is pregnant or breastfeeding, or pregnancy is planned during the course of the investigation
* Active endocarditis or other infection producing bacteremia
* Transient case of AF (i.e., never previously detected, provoked/induced by surgical or catheter manipulations, etc.)
* Severe renal failure (estimated glomerular filtration rate <30 ml/min/1.73m2), but not on dialysis
* Life expectancy is less than 2 years in the opinion of the Investigator
* Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the Investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow up requirements, or impact the scientific soundness of the clinical investigation results.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2030
Actual
Sample size
Target
2650
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - City Campus - Parkville
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
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Alabama
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Massa
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Milano
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Aichi
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Chiba
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Fukuoka
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Ibaraki
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Kanagawa
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Miyagi
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Okayama
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Tokyo
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Vilnius
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Nieuwegein
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Zabrze
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Lódz
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Community Of Madrid
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Brighton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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 website
https://clinicaltrials.gov/study/NCT04226547
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vivek Reddy, MD
Address 0 0
Mt. Sinai Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
CATALYST Study Team
Address 0 0
Country 0 0
Phone 0 0
(408) 845-0536
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04226547