Atrial Fibrillation (AF)NCT06707688
Abbott Medical - VERITAS Study
A study testing Amulet™ 2 Left Atrial Appendage (LAA) Occluder in people with Atrial Fibrillation (AF) and Stoke, run by Abbott Medical Devices at 35 sites in 9 countries.
Trial summary
The primary objective of this study is to evaluate the safety and effectiveness of Abbott's Amulet™ 2 Left Atrial Appendage (LAA) occluder device (Amulet 2 device) in patients who have non-valvular atrial fibrillation and who are at increased risk for stroke and systemic embolism and have appropriate rationale to seek… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Stoke
- What is being tested?
- Amulet™ 2 Left Atrial Appendage (LAA) Occluder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 35 sitesin 9 countries
- Study dates
- 7 Nov 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular AF and has not been diagnosed with rheumatic mitral valve disease
- CHA2DS2-VASc score of ≥2 for males or ≥3 for females
- Has an appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation
- Subject is eligible to stop anticoagulation if the LAA is sealed based on the implanting physician's opinion
- Subject is able to comply with the protocol defined pharmacologic regimen following Amulet 2 device implant (as described in Section 6.5)
- Subject is able to understand and willing to provide written informed consent to participate in the clinical investigation
- Subject is able and willing to return for required follow-up visits and protocol required clinical investigation activities
- 18 years of age or older, or the age of legal consent
Who cannot join
- Required to take P2Y12 platelet inhibitor beyond 6 months when Amulet 2 LAA Occluder implant procedure would occur
- Is considered at high risk for general anesthesia in the opinion of the Investigator or based on past adverse reaction(s) requiring medical intervention or which resulted in prolongation of hospital stay
- Atrial septal defect or patent foramen ovale repair or occluder
- Implanted with a mechanical valve prosthesis
- Subject anatomy will not accommodate or is contraindicated for transesophageal echocardiography probe use (e.g., presence of esophageal varices, esophageal stricture, or history of esophageal cancer), or subject has experienced adverse events related to transesophageal echocardiography acquisition or has refused transesophageal echocardiography acquisition in the past
- Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to when Amulet 2 device implant procedure would occur (any intervention or surgery that utilized anesthesia, anesthetic, or sedation)
Show all 36Show fewer
- Underwent catheter ablation for AF or atrial flutter within 60 days prior to when Amulet 2 device implant procedure would occur
- Inpatient hospitalization due to clinical event or other sequelae within the past 7 days (i.e., not related to planned clinical study procedure or assessments)
- Subject is planning any cardiac or non-cardiac intervention or surgery within 60 days after when Amulet 2 device implant procedure would occur (any intervention or surgery that utilized anesthesia, anesthetic, or sedation), except for study related activities
- Inferior vena cava filter present
- Left ventricular ejection fraction ≤30% (per most recent assessment)
- Experienced stroke or transient ischemic attack within 90 days prior to when Amulet 2 device implant procedure would occur
- Experienced myocardial infarction (with or without intervention) within 90 days prior to when Amulet 2 device implant procedure would occur
- New York Heart Association (NYHA) Class IV Congestive Heart Failure
- Known 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
- Underwent prior attempted endocardial, epicardial, or surgical LAA closure or occlusion, defined as deployment of a device or surgical procedure whether successful or unsuccessful
- 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 within the past 5 years
- Thrombocytopenia (defined as < 50,000 platelets per microliter (<50 x 109/L) or anemia (defined as hemoglobin < 10 g/dL) requiring transfusions
- Known hypersensitivity to any portion of the device material or individual components of the Amulet 2 device (e.g., nickel allergy)
- Actively enrolled in, or plans to enroll in, a concurrent clinical investigation in which the active treatment arm may confound the results of the VERITAS Study. Each instance must be brought to the attention of the Sponsor to determine eligibility.
- 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) or on chronic 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.
- Anatomical Exclusion Criteria:
- Intracardiac thrombus
- Existing circumferential pericardial effusion >2 mm
- Mitral valve stenosis, defined as a mitral valve area of <1.5 cm2
- Inter-atrial communication (PFO/ASD with right to left shunt, if TEE performed) with an atrial septal aneurysm (excursion >15 mm or length ≥15 mm; excursion defined as maximal protrusion of the atrial septal aneurysm beyond the plane of the atrial septum) or large shunt (i.e., during Valsalva maneuver ≥20 bubbles of right-to-left shunt within 3 cardiac cycles after contrast media enters the right atrium, if TEE performed)
- Complex atheroma of the descending aorta and/or aortic arch, defined as plaque >4 mm in thickness, plaque ulceration, and/or mobile lesions
- Cardiac tumor
- LAA anatomy that cannot accommodate the Amulet 2 device, as per manufacturer's IFU (i.e., the LAA size must be within the sizing chart of the Amulet 2 device)
- Placement of the device would damage or interfere with the function of any intracardiac or intravascular structure
Trial locations and contacts
35 sites in 9 countries.
35 sites in 9 countries
United States19 sites
Northside Hospital
Atlanta, Georgia, 30342
Texas Cardiac Arrhythmia
Austin, Texas, 78705
Roper Hospital
Charleston, South Carolina, 29401
Trident Medical Center
Charleston, South Carolina, 29406
Baylor Scott & White All Saints Medical Center
Fort Worth, Texas, 76104
Vital Heart and Vein
Humble, Texas, 77338
Baptist Medical Center
Jacksonville, Florida, 32207
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee, 37232
NYU Langone Health
New York, New York, 10016
Mount Sinai Hospital
New York, New York, 10019
CHI Health Creighton University Medical Center-Bergan Mercy
Omaha, Nebraska, 68124
AdventHealth Orlando
Orlando, Florida, 32803
Kansas City Cardiac Arrhythmia Research Foundation
Overland Park, Kansas, 66211
Arizona Arrhythmia Research Group
Phoenix, Arizona, 85016
Baylor Scott & White - The Heart Hospital Plano
Plano, Texas, 75093
Mayo Clinic
Rochester, Minnesota, 55905
Heart Rhythm Associates
Shenandoah, Texas, 77380
Henry Ford Providence Southfield Hospital
Southfield, Michigan, 48075
Germany4 sites
Deutsches Herzzentrum der Charité
Berlin
Cardioangiologisches Centrum am Bethanien Krankenhaus
Frankfurt am Main, Hesse
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck
Heinrich-Braun-Klinikum gemeinnützige gGmbH Standort Zwickau
Zwickau
Spain3 sites
Hospital Clínic de Barcelona
Barcelona
Hospital Clinico San Carlos
Madrid
Hospital Universitario de Salamanca
Salamanca
Canada2 sites
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec
University of Ottawa Heart Institute
Ottawa, Ontario, K18 4W7
France2 sites
CHU Gabriel Montpied
Clermont-Ferrand, Auvergn
Institute Cardio. Paris-Sud - Institut Jacques Cartier
Massy
About this study
The primary objective of this study is to evaluate the safety and effectiveness of Abbott's Amulet™ 2 Left Atrial Appendage (LAA) occluder device (Amulet 2 device) in patients who have non-valvular atrial fibrillation and who are at increased risk for stroke and systemic embolism and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation.
- Conditions
- Atrial Fibrillation (AF), Stoke
- Being tested
- Amulet™ 2 Left Atrial Appendage (LAA) Occluder
- Keywords
- Left Atrial Appendage, LAA Occluder, Afib, Amulet, Abbott, VERITAS
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amulet™ 2 Left Atrial Appendage (LAA) OccluderDevice
Patient will undergo the implantation of the Amulet™ 2 Left Atrial Appendage (LAA) Occluder
| Study group | Role | What they receive |
|---|---|---|
| Amulet™ 2 Left Atrial Appendage (LAA) Occluder | Experimental | Transcatheter left atrial appendage (LAA) occluder Receives: Device: Amulet™ 2 Left Atrial Appendage (LAA) Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary safety endpoint is the occurrence of any prespecified safety events through 7 days post-procedure or hospital discharge, whichever is later.
The primary safety endpoint is the occurrence of any of the following events through 7 days post-procedure or hospital discharge, whichever is later: death, ischemic stroke, systemic embolism, or device/procedure related complications requiring open cardiac surgery or major endovascular intervention. Device/procedure related events contributing to the primary endpoint may include pseudoaneurysm or AV fistula repair, whereas percutaneous drainage of pericardial effusion, snaring of embolized devices, thrombin injection or nonsurgical treatment of access site complications will not contribute to the primary endpoint.
Measured: 7 days post-procedure or hospital discharge
The primary effectiveness endpoint is LAA occlusion defined as no peri-device flow or peri-device flow ≤5mm based on TEE/TOE at the 45-day follow-up visit.
The primary effectiveness endpoint is LAA occlusion defined as no peri-device flow or peri-device flow ≤5mm based on Doppler color flow TEE/TOE at the 45-day follow-up visit as assessed by an independent core laboratory.
Measured: 45 days
Secondary outcomes (1)
The secondary effectiveness endpoint is the composite of ischemic stroke or systemic embolism at 24 months.
The secondary effectiveness endpoint is the composite of ischemic stroke or systemic embolism at 24 months.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start7 Nov 2024
- Primary completion6 Nov 2025
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ryan Palmer, Study director, Abbott MedicalDevi Nair, MD, Principal investigator, Arrhythmia Research GroupMohamad Alkhouli, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707688
- Sponsor's protocol ID
- ABT-CIP-10523
- Other IDs
- G240218
- Status last verified
- Jun 2026
- First submitted
- 25 Nov 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Nair D, Freixa X, Ellis CR, Lakkireddy D, Nielsen-Kudsk JE, Horton R, Reddy VY, Makkar A, Ibrahim R, Agarwal H, de Backer O, Sabir S, Weiler C, Alkhouli M; VERITAS Investigators. Early Outcomes With a Next-Generation Dual-Seal Left Atrial Appendage Occluder: Results From the VERITAS Study. JACC Clin Electrophysiol. 2026 Jun;12(6):1331-1341. doi: 10.1016/j.jacep.2026.01.021. Epub 2026 Feb 6.
PubMed 41701134
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abbott Medical - VERITAS Study
- ClinicalTrials.gov ID
- NCT06707688
- Acronym / sponsor ID
- ABT-CIP-10523
- Conditions
- Atrial Fibrillation (AF), Stoke
- Keywords
- Left Atrial Appendage, LAA Occluder, Afib, Amulet, Abbott, VERITAS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 6 Nov 2025 (actual)
- Study completion
- Sep 2027 (estimated)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and effectiveness of Abbott's Amulet™ 2 Left Atrial Appendage (LAA) occluder device (Amulet 2 device) in patients who have non-valvular atrial fibrillation and who are at increased risk for stroke and systemic embolism and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amulet™ 2 Left Atrial Appendage (LAA) Occluder | Experimental | Device: Amulet™ 2 Left Atrial Appendage (LAA) OccluderTranscatheter left atrial appendage (LAA) occluder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular AF and has not been diagnosed with rheumatic mitral valve disease
- CHA2DS2-VASc score of ≥2 for males or ≥3 for females
- Has an appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation
- Subject is eligible to stop anticoagulation if the LAA is sealed based on the implanting physician's opinion
- Subject is able to comply with the protocol defined pharmacologic regimen following Amulet 2 device implant (as described in Section 6.5)
Key exclusion criteria (36 listed)
- Required to take P2Y12 platelet inhibitor beyond 6 months when Amulet 2 LAA Occluder implant procedure would occur
- Is considered at high risk for general anesthesia in the opinion of the Investigator or based on past adverse reaction(s) requiring medical intervention or which resulted in prolongation of hospital stay
- Atrial septal defect or patent foramen ovale repair or occluder
- Implanted with a mechanical valve prosthesis
- Subject anatomy will not accommodate or is contraindicated for transesophageal echocardiography probe use (e.g., presence of esophageal varices, esophageal stricture, or history of esophageal cancer), or subject has experienced adverse events related to transesophageal echocardiography acquisition or has refused transesophageal echocardiography acquisition in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amulet™ 2 Left Atrial Appendage (LAA) OccluderPatient will undergo the implantation of the Amulet™ 2 Left Atrial Appendage (LAA) Occluder | Device | Amulet™ 2 Left Atrial Appendage (LAA) Occluder |
Primary outcome
The primary safety endpoint is the occurrence of any prespecified safety events through 7 days post-procedure or hospital discharge, whichever is later.
Time frame: 7 days post-procedure or hospital discharge
The primary safety endpoint is the occurrence of any of the following events through 7 days post-procedure or hospital discharge, whichever is later: death, ischemic stroke, systemic embolism, or device/procedure related complications requiring open cardiac surgery or major endovascular intervention. Device/procedure related events contributing to the primary endpoint may include pseudoaneurysm or AV fistula repair, whereas percutaneous drainage of pericardial effusion, snaring of embolized devices, thrombin injection or nonsurgical treatment of access site complications will not contribute to the primary endpoint.
The primary effectiveness endpoint is LAA occlusion defined as no peri-device flow or peri-device flow ≤5mm based on TEE/TOE at the 45-day follow-up visit.
Time frame: 45 days
The primary effectiveness endpoint is LAA occlusion defined as no peri-device flow or peri-device flow ≤5mm based on Doppler color flow TEE/TOE at the 45-day follow-up visit as assessed by an independent core laboratory.
1 secondary outcome
The secondary effectiveness endpoint is the composite of ischemic stroke or systemic embolism at 24 months.
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Derived from this study: PubMed 41701134Nair D, Freixa X, Ellis CR, Lakkireddy D, Nielsen-Kudsk JE, Horton R, Reddy VY, Makkar A, Ibrahim R, Agarwal H, de Backer O, Sabir S, Weiler C, Alkhouli M; VERITAS Investigators. Early Outcomes With a Next-Generation Dual-Seal Left Atrial Appendage Occluder: Results From the VERITAS Study. JACC Clin Electrophysiol. 2026 Jun;12(6):1331-1341. doi: 10.1016/j.jacep.2026.01.021. Epub 2026 Feb 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Palmer study director
Abbott Medical
Devi Nair, MD principal investigator
Arrhythmia Research Group
Mohamad Alkhouli, MD principal investigator
Mayo Clinic
35 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amulet™ 2 Left Atrial Appendage (LAA) Occluder in people with Atrial Fibrillation (AF) and Stoke, run by Abbott Medical Devices at 35 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Germany, Spain, Canada, Denmark and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary safety endpoint is the occurrence of any prespecified safety events through 7 days post-procedure or hospital discharge, whichever is later. (time frame: 7 days post-procedure or hospital discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06707688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.