Amplatzer Amulet LAAO vs. NOAC

Stroke Clinical Trial

— CATALYST  

Official title:

Clinical Trial of Atrial Fibrillation Patients Comparing Left Atrial Appendage Occlusion Therapy to Non-vitamin K Antagonist Oral Anticoagulants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04226547
• Other study ID #: 10310
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2020
• Est. completion date: August 2030

Study information

• Verified date: April 2024
• Source: Abbott Medical Devices
• Contact: CATALYST Study Team
• Phone: (408) 845-0536
• Email: catalyststudy[@]abbott.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2650
• Est. completion date: August 2030
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Bleeding
• Stroke

Intervention

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

Drug:
• Non-Vitamin K Oral Antagonists
Initiation or continuation of a NOAC drug

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Royal Melbourne Hospital - City Campus	Parkville
Canada	CHUM	Montréal
Canada	Institut de Cardiologie de Montreal (Montreal Heart Inst.)	Montréal
Canada	Ottawa Heart Institute	Ottawa	Ontario
Canada	Vancouver General Hospital (U of BC)	Vancouver
Czechia	Fakultni nemocnice Kralovske Vinohrady	Prague
Czechia	Nemocnice Na Homolce	Prague
Denmark	Skejby University Hospital	Arhus
Denmark	Rigshospitalet	Copenhagen
France	CHU Gabriel Montpied	Clermont-Ferrand
France	Hopital Henri Mondor	Créteil
France	Institute Cardio. Paris-Sud - Institut Jacques Cartier	Massy
France	Mutualiste Montsouris	Paris
France	Hopital Haut Leveque	Pessac
Germany	Segeberger Kliniken GmbH	Bad Segeberg
Germany	Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)	Berlin	Brandenburg
Germany	St. Marien-Hospital-Bonn	Bonn
Germany	Cardioangiologisches Centrum am Bethanien Krankenhaus	Frankfurt
Germany	Klinikum der Justus-Liebig-Universität	Gießen
Germany	Universitätsklinikum Schleswig-Holstein - Campus Lübeck	Lübeck	Schleswig-Holstein
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz
Germany	Internistisches Klinikum München SUD	Munich
Germany	Helios Klinikum Siegburg	Siegburg
Hong Kong	Prince of Wales Hospital	Hong Kong
Hong Kong	Queen Elizabeth Hospital	Hong Kong
Hong Kong	The University of Hong Kong (Queen Mary Hospital)	Hong Kong
Italy	Fondazione Toscana Gabriele Monasterio	Massa
Italy	Ospedale San Raffaele	Milano
Japan	Chiba University	Chiba-shi	Chiba
Japan	Shonan Kamakura General Hospital	Kamakura	Kanagawa
Japan	Kokura Memorial Hospital	Kitakyushu	Fukuoka
Japan	Kurashiki Central Hospital	Kurashiki-shi	Okayama
Japan	Toho University Ohashi Medical Center	Meguro-ku	Tokyo
Japan	Sendai Kousei Hospital	Sendai	Miyagi
Japan	Tokyo Medical and Dental University Hospital of Medicine	Tokyo
Japan	Toyohashi Heart Center	Toyohashi	Aichi
Japan	University of Tsukuba Hospital	Tsukuba	Ibaraki
Lithuania	Vilnius University Hospital Santariskiu Klinikos	Vilnius
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Poland	Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi	Lódz
Poland	Slaskie Centrum Chorob Serca	Zabrze
Spain	Hospital Clinic I Provincial de Barcelona	Barcelona
Spain	Hospital de la Santa Creu I Sant Pau	Barcelona
Spain	Hospital Clinico San Carlos	Madrid	Community Of Madrid
Spain	Hospital Universitario de Salamanca	Salamanca
Switzerland	Center Inselspital Bern	Bern
Switzerland	Stadtspital Triemli	Zürich
United Kingdom	The Royal Sussex County Hospital	Brighton
United States	New Mexico Heart Institute	Albuquerque	New Mexico
United States	AdventHealth Florida Cardiology - Altamonte Springs	Altamonte Springs	Florida
United States	Mission Health & Hospitals	Asheville	North Carolina
United States	Emory University Hospital	Atlanta	Georgia
United States	Northside Hospital	Atlanta	Georgia
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Texas Cardiac Arrhythmia	Austin	Texas
United States	MedStar Union Memorial Hospital	Baltimore	Maryland
United States	Louisiana Cardiology Associates	Baton Rouge	Louisiana
United States	University Hospital - Univ. of Alabama at Birmingham (UAB)	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Buffalo General Hospital	Buffalo	New York
United States	Cooper University Hospital	Camden	New Jersey
United States	Roper Hospital	Charleston	South Carolina
United States	Erlanger Medical Center	Chattanooga	Tennessee
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	TriHealth Bethesda North Hospital	Cincinnati	Ohio
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Lutheran Hospital of Indiana	Fort Wayne	Indiana
United States	Baylor All Saints Medical Center at Fort Worth	Fort Worth	Texas
United States	Spectrum Health Butterworth Hospital	Grand Rapids	Michigan
United States	Pinnacle Health System	Harrisburg	Pennsylvania
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	CHI St. Luke's Health Baylor College of Medicine Med. Ctr.	Houston	Texas
United States	Memorial Hermann Hospital	Houston	Texas
United States	Memorial Katy Cardiology Associates	Houston	Texas
United States	Park Plaza Hospital	Houston	Texas
United States	The Methodist Hospital	Houston	Texas
United States	Heart Center Research, LLC	Huntsville	Alabama
United States	St. Vincent Hospital	Indianapolis	Indiana
United States	Jackson Heart Clinic	Jackson	Mississippi
United States	Baptist Medical Center	Jacksonville	Florida
United States	St. Vincent's Medical Center	Jacksonville	Florida
United States	Arrhythmia Research Group	Jonesboro	Arkansas
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Tennova Healthcare-Turkey Creek Medical Center	Knoxville	Tennessee
United States	Scripps Health	La Jolla	California
United States	AdventHealth Florida Cardiology - Lake Mary	Lake Mary	Florida
United States	Northside Hospital (CardioVascular Group Lawrenceville)	Lawrenceville	Georgia
United States	Baptist Health Lexington	Lexington	Kentucky
United States	Bryan Heart	Lincoln	Nebraska
United States	UAMS Medical Center	Little Rock	Arkansas
United States	South Denver Cardiology Associates PC	Littleton	Colorado
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	VA Medical Center Minneapolis	Minneapolis	Minnesota
United States	NCH Healthcare System	Naples	Florida
United States	Vanderbilt Heart & Vascular Institute	Nashville	Tennessee
United States	Mount Sinai Hospital	New York	New York
United States	New York Presbyterian Hospital/Cornell University	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Hightower Clinical	Oklahoma City	Oklahoma
United States	Integris Baptist Medical Center	Oklahoma City	Oklahoma
United States	CHI Health Creighton University Medical Center-Bergan Mercy	Omaha	Nebraska
United States	AdventHealth Orlando	Orlando	Florida
United States	Kansas City Cardiac Arrhythmia Research Foundation	Overland Park	Kansas
United States	AdventHealth Florida Cardiology - Oviedo	Oviedo	Florida
United States	Huntington Memorial Hospital	Pasadena	California
United States	Arizona Cardiovascular Research Center	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	NC Heart & Vascular Research	Raleigh	North Carolina
United States	Mercy Medical Group - Cardiology	Sacramento	California
United States	St. Cloud Hospital - Central MN Heart Clinic	Saint Cloud	Minnesota
United States	Methodist Texsan Hospital	San Antonio	Texas
United States	University of California at San Diego (UCSD) Medical Center	San Diego	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Heart Rhythm Associates	Shenandoah	Texas
United States	Sanford USD Medical Center	Sioux Falls	South Dakota
United States	Tucson Medical Center	Tucson	Arizona
United States	Oklahoma Heart Institute at Utica	Tulsa	Oklahoma
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Cardiovascular Research Institute of Kansas	Wichita	Kansas
United States	Central DuPage Hospital	Winfield	Illinois
United States	WellSpan Health	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czechia,  Denmark,  France,  Germany,  Hong Kong,  Italy,  Japan,  Lithuania,  Netherlands,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of ischemic stroke, systemic embolism, or cardiovascular (CV) mortality	non-inferiority	2 years
Primary	Major bleeding or clinically relevant non-major bleeding (CRNMB) events, excluding procedure related events	superiority	2 years
Primary	Composite of ischemic stroke or systemic embolism	non-inferiority	3 years
Secondary	Major bleeding or CRNMB events	non-inferiority	2 years
Secondary	Major bleeding or CRNMB events	superiority	2 years
Secondary	Disabling or fatal strokes	superiority	2 years