The GLACE Study: Evaluating CLAAS With ICE Guided LAA Closure

NCT06580275 | Active Not Recruiting FDA Device

• 1 other identifier: 24-101
• Study Type: interventional
• Target: 80
• Locations: 3 countries
• Sites: 4

Brief 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.

Conditions

Atrial Fibrillation; Stroke Prevention

Keywords

Atrial fibrillation; Stroke; ICE; Conformal; LAAO

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  7 Days

Secondary Outcomes (8)

• Stroke: Ischemic, Hemorrhagic, Disabling, Non-Disabling

  12 Months

• Bleeding (BARC 3-5)

  14 Days

• Device Leak

  45 Days

• Pericardial Effusion requiring drainage

  12 Months

• Procedural and Device related AEs and SAEs

  1 Day

Study Arms (1)

CLAAS

EXPERIMENTAL

In this single arm study, all eligible subjects will be assigned to receive the CLAAS device.

Device: CLAAS

Interventions

CLAAS DEVICE

All eligible subjects will have an LAA closure attempt using the CLAAS device guided by ICE technology.

CLAAS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Conformal Medical, Inc: lead

Study Sites (4)

Na Homolce Hospital

Prague, 150 30, Czechia

Location

Aarhus University Hospital, Skejby

Aarhus, DK-8200, Denmark

Location

University Hospital of Copenhagen

Copenhagen, DK-2100, Denmark

Location

Fondazione Toscana Gabriele Monasterio

Massa, 54100, Italy

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 30, 2024
• Study Start: September 24, 2024
• Primary Completion: November 10, 2025
• Study Completion (Estimated): September 22, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

DK (2); CZ (1); IT (1)