Atrial FibrillationNCT06580275
The GLACE Study: Evaluating CLAAS With ICE Guided LAA Closure
A study testing CLAAS in people with Atrial Fibrillation and Stroke Prevention, run by Conformal Medical, Inc at 4 sites in 3 countries.
Trial summary
The CLAAS® device will be evaluated for safety and performance in the reduction of stroke in subjects with non-valvular atrial fibrillation under intracardiac echocardiography (ICE) imaging for left atrial appendage closure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke Prevention
- What is being tested?
- CLAAS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 24 Sep 2024to 8 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Male or non-pregnant female aged ≥18 years.
- Documented non-valvular AF (paroxysmal, persistent, or permanent).
- High risk of stroke or systemic embolism, defined as CHADS2 score of ≥2 or CHA2DS2-VASc score of ≥3.
- Has an appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation including contraindications to long term oral anti-coagulation inclusive of history of intracranial bleed, subdural hematoma, gastrointestinal bleeding, hematuria, epistaxis, falls, and other less common conditions. Also included is the inability to reliably take medications and reluctance to take a blood thinner.
- Deemed by investigator to be suitable for short term oral anticoagulation therapy but deemed less favorable for long-term oral anticoagulation therapy.
- Deemed appropriate for LAA closure by the site investigator and a clinician not a part of the procedural team using a shared decision-making process in accordance with standard of care.
- Able to comply with the protocol-specified medication regimen and follow-up evaluations.
- The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate institutional review board (IRB)/Regional Ethics Board (REB)/Ethics Committee (EC).
Who cannot join
- Pregnant or nursing patients and those who plan pregnancy in the period up to one year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.
- Anatomic conditions that would prevent performance of an LAA occlusion procedure (e.g., prior atrial septal defect [ASD] or patent foramen ovale [PFO], surgical repair or implanted closure device, or obliterated or ligated left atrial appendage).
- Atrial fibrillation that is defined by a single occurrence or that is transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures).
- A medical condition (other than atrial fibrillation) that mandates long-term oral anticoagulation (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or mechanical heart valve).
- History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated.
- Documented active systemic infection.
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- Symptomatic carotid artery disease (defined as >50% stenosis 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% stenosis noted at the site of prior treatment.
- Recent (within 30 days of index procedure) or planned (within 60 days post-procedure) cardiac or non-cardiac interventional or surgical procedure.
- Recent (within 30 days of index procedure) stroke or transient ischemic attack.
- Recent (within 30 days of index procedure) myocardial infarction.
- Vascular access precluding delivery of implant with catheter-based system.
- Severe heart failure (New York Heart Association Class IV).
- Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any mechanical valve implant.
- Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) <30mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation).
- Platelet count <75,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <3,000 cells/mm3.
- Known allergy, hypersensitivity or contraindication to aspirin, heparin, or device materials (e.g., nickel, titanium) that would preclude any P2Y12 inhibitor therapy, or the patient has contrast sensitivity that cannot be adequately pre-medicated.
- Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this study.
- Unable to undergo general anesthesia.
- Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol or protocol-specified medication regimen, confound the data interpretation, or is associated with a life expectancy of less than 5 years.
- A condition which precludes adequate transesophageal echocardiographic (TEE) assessment or ICE guided imaging during the procedure.
- Imaging Exclusion Criteria:
- Left atrial appendage anatomy which cannot accommodate the CLAAS device per manufacturer IFU (e.g., the anatomy and sizing must be appropriate for the test (CLAAS) device in order to be enrolled in the trial).
- Intracardiac thrombus or dense spontaneous echo contrast consistent with thrombus, as visualized by pre-procedural imaging (TEE or Cardiac CT) or baseline procedural ICE prior to implant.
- Left ventricular ejection fraction (LVEF) <30%.
- Moderate or large circumferential pericardial effusion >10mm or symptomatic pericardial effusion, signs or symptoms of acute or chronic pericarditis, or evidence of tamponade physiology.
- Atrial septal defect that warrants closure.
- High risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (excursion >15mm or length >15mm) or large shunt (early [within 3 beats] and/or substantial passage of bubbles, e.g., ≥20).
- Moderate or severe mitral valve stenosis (mitral valve area <1.5cm2).
- Complex atheroma with mobile plaque of the descending aorta and/or aortic arch.
- Evidence of cardiac tumor.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Denmark2 sites
Aarhus University Hospital, Skejby
Aarhus, DK-8200
University Hospital of Copenhagen
Copenhagen, DK-2100
About this study
Official title: The GLACE Study: A Prospective Multi-center Single Arm Study Evaluating the Safety and Performance of the CLAAS Device With ICE Guided LAA Closure.
The CLAAS® device will be evaluated for safety and performance in the reduction of stroke in subjects with non-valvular atrial fibrillation under intracardiac echocardiography (ICE) imaging for left atrial appendage closure.
- Conditions
- Atrial Fibrillation, Stroke Prevention
- Being tested
- CLAAS
- Keywords
- Atrial fibrillation, Stroke, ICE, Conformal, LAAO
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLAASDevice
All eligible subjects will have an LAA closure attempt using the CLAAS device guided by ICE technology.
| Study group | Role | What they receive |
|---|---|---|
| CLAAS | Experimental | In this single arm study, all eligible subjects will be assigned to receive the CLAAS device. Receives: Device: CLAAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful LAA closure (Evaluated at 45 Days Post-procedure)
Complete closure is defined as absence of a significant leak (>5 mm) as assessed based upon core lab evaluation of 45 Day Imaging assessment without device or procedure related SAEs.
Measured: 45 Days
Successful LAA closure without procedural complication within 7 days post-procedure
The absences of any of the following complications: Cardiac perforation, pericardial effusion requiring drainage, ischemic stroke, device embolization, and major vascular complications.
Measured: 7 Days
Secondary outcomes (8)
Stroke: Ischemic, Hemorrhagic, Disabling, Non-Disabling
Measured: 12 Months
Bleeding (BARC 3-5)
Procedural and Non-Procedural
Measured: 14 Days
Device Leak
>5 mm, 3-5 mm, 1-3 mm leak is based on core lab imaging assessment at 45 days
Measured: 45 Days
Pericardial Effusion requiring drainage
Measured: 12 Months
Procedural and Device related AEs and SAEs
Measured: 1 Day
Device Success
CLAAS implantation in correct position without complications till discharge
Measured: 1 Day
Conversion to TEE
Measured: 1 Day
Conversion to general anesthesia (GA) with endotracheal intubation
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start24 Sep 2024
- Primary completion10 Nov 2025
- Study completion8 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conformal Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580275
- Sponsor's protocol ID
- 24-101
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The GLACE Study: A Prospective Multi-center Single Arm Study Evaluating the Safety and Performance of the CLAAS Device With ICE Guided LAA Closure.
- ClinicalTrials.gov ID
- NCT06580275
- Acronym / sponsor ID
- 24-101
- Conditions
- Atrial Fibrillation, Stroke Prevention
- Keywords
- Atrial fibrillation, Stroke, ICE, Conformal, LAAO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Conformal Medical, IncIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 8 Sep 2026 (actual)
- First posted
- 30 Aug 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 CLAAS® device will be evaluated for safety and performance in the reduction of stroke in subjects with non-valvular atrial fibrillation under intracardiac echocardiography (ICE) imaging for left atrial appendage closure.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLAAS | Experimental | Device: CLAASIn this single arm study, all eligible subjects will be assigned to receive the CLAAS device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or non-pregnant female aged ≥18 years.
- Documented non-valvular AF (paroxysmal, persistent, or permanent).
- High risk of stroke or systemic embolism, defined as CHADS2 score of ≥2 or CHA2DS2-VASc score of ≥3.
- Has an appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation including contraindications to long term oral anti-coagulation inclusive of history of intracranial bleed, subdural hematoma, gastrointestinal bleeding, hematuria, epistaxis, falls, and other less common conditions. Also included is the inability to reliably take medications and reluctance to take a blood thinner.
- Deemed by investigator to be suitable for short term oral anticoagulation therapy but deemed less favorable for long-term oral anticoagulation therapy.
Key exclusion criteria (30 listed)
- Pregnant or nursing patients and those who plan pregnancy in the period up to one year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.
- Anatomic conditions that would prevent performance of an LAA occlusion procedure (e.g., prior atrial septal defect [ASD] or patent foramen ovale [PFO], surgical repair or implanted closure device, or obliterated or ligated left atrial appendage).
- Atrial fibrillation that is defined by a single occurrence or that is transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures).
- A medical condition (other than atrial fibrillation) that mandates long-term oral anticoagulation (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or mechanical heart valve).
- History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated.
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 |
|---|---|---|
| CLAASAll eligible subjects will have an LAA closure attempt using the CLAAS device guided by ICE technology. | Device | CLAAS |
Primary outcome
Successful LAA closure (Evaluated at 45 Days Post-procedure)
Time frame: 45 Days
Complete closure is defined as absence of a significant leak (>5 mm) as assessed based upon core lab evaluation of 45 Day Imaging assessment without device or procedure related SAEs.
Successful LAA closure without procedural complication within 7 days post-procedure
Time frame: 7 Days
The absences of any of the following complications: Cardiac perforation, pericardial effusion requiring drainage, ischemic stroke, device embolization, and major vascular complications.
8 secondary outcomes
Stroke: Ischemic, Hemorrhagic, Disabling, Non-Disabling
Time frame: 12 Months
Bleeding (BARC 3-5)
Time frame: 14 Days
Device Leak
Time frame: 45 Days
Pericardial Effusion requiring drainage
Time frame: 12 Months
Procedural and Device related AEs and SAEs
Time frame: 1 Day
Device Success
Time frame: 1 Day
Conversion to TEE
Time frame: 1 Day
Conversion to general anesthesia (GA) with endotracheal intubation
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLAAS in people with Atrial Fibrillation and Stroke Prevention, run by Conformal Medical, Inc at 4 sites in 3 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 30 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: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, Czechia, Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Successful LAA closure (Evaluated at 45 Days Post-procedure) (time frame: 45 Days). 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?
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 30 Sep 2026.