Atrial FibrillationNCT06099106
Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device
A study testing SEPIOLA System in people with Atrial Fibrillation, run by Endomatic Ltd. at 5 sites in 4 countries.
Trial summary
The study is designed to evaluate the safety and performance of the ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients with non-valvular Atrial Fibrillation, who are at increased risk for stroke, and that cannot take, or have a reason to seek an alternative, to long-term anticoagulation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- SEPIOLA System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 1 May 2023to May 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
- calculated CHA2DS2-VASc score of 2 or greater.
- The subject is non-eligible or have an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulants.
- documented non-valvular atrial fibrillation
- Subject suitable for vascular/cardiac intervention procedure
- suitable LAA anatomical measurements for study device
Who cannot join
- Subject who requires anticoagulation for a condition other than AF.
- NYHA classification IV.
- Complex congenital heart disease.
- Presence of circumflex coronary artery stent.
- The subject has a prosthetic valve in any position.
- atrial septal defect closure or has an ASD/PFO device.
Show all 11Show fewer
- presence of intracardiac thrombus.
- Any cardiac surgery in the past
- LVEF < 35%.
- intracardiac thrombus
- moderate or severe mitral valve stenosis
Trial locations and contacts
5 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 4 countries
Georgia2 sites
- Completed
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, 0112
- Completed
Tbilisi Heart and Vascular Clinic
Tbilisi, 0159
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius university hospital Santaros Klinikos
Vilnius
Gediminas Račkauskas, MD, Gediminas.Rackauskas@santa.lt
Poland1 site, 1 recruiting
- Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan
Marek Grygier, MD, marek.grygier@usk.poznan.pl
Uzbekistan1 site, 1 recruiting
- Recruiting
Ezgu Niyat
Tashkent
Askar Sabirov, MD
About this study
Official title: Evaluation of the Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation
The study is designed to evaluate the safety and performance of the ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients with non-valvular Atrial Fibrillation, who are at increased risk for stroke, and that cannot take, or have a reason to seek an alternative, to long-term anticoagulation therapy.
Potential patients who are candidates for LAA closure will be screened to confirm that all inclusion/exclusion criteria are met, with final eligibility confirmation on day of procedure.
Read more
All enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge.
Additional follow up time points are scheduled at 45 days, 6 months and 12 months post procedure.
- Conditions
- Atrial Fibrillation
- Being tested
- SEPIOLA System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEPIOLA SystemDevice
Implantation of the SEPIOLA device into the left atrial appendage.
| Study group | Role | What they receive |
|---|---|---|
| Implantable device | Experimental | Endomatic SEPIOLA System Receives: Device: SEPIOLA System |
What is being measured
The primary outcome is the main question the study is designed to answer.
SEPIOLA System Safety
Device and Investigational Procedure Related Serious Adverse Events (SAE)
Measured: 7 days, 45 days and 6 months post procedure
Secondary outcomes (1)
Device success
Confirmation of functional LAA closure
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 May 2023
- Primary completionJun 2026 (estimated)
- Study completionMay 2027 (estimated)
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endomatic Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099106
- Sponsor's protocol ID
- DMS-6283
- Status last verified
- Aug 2025
- First submitted
- 19 Oct 2023
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06099106
- Acronym / sponsor ID
- DMS-6283
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Endomatic Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 May 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 25 Oct 2023 (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 study is designed to evaluate the safety and performance of the ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients with non-valvular Atrial Fibrillation, who are at increased risk for stroke, and that cannot take, or have a reason to seek an alternative, to long-term anticoagulation therapy.
Potential patients who are candidates for LAA closure will be screened to confirm that all inclusion/exclusion criteria are met, with final eligibility confirmation on day of procedure.
All enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge.
Additional follow up time points are scheduled at 45 days, 6 months and 12 months post procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantable device | Experimental | Device: SEPIOLA SystemEndomatic SEPIOLA System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- calculated CHA2DS2-VASc score of 2 or greater.
- The subject is non-eligible or have an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulants.
- documented non-valvular atrial fibrillation
- Subject suitable for vascular/cardiac intervention procedure
- suitable LAA anatomical measurements for study device
Key exclusion criteria (11 listed)
- Subject who requires anticoagulation for a condition other than AF.
- NYHA classification IV.
- Complex congenital heart disease.
- Presence of circumflex coronary artery stent.
- The subject has a prosthetic valve in any position.
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 |
|---|---|---|
| SEPIOLA SystemImplantation of the SEPIOLA device into the left atrial appendage. | Device | Implantable device |
Primary outcome
SEPIOLA System Safety
Time frame: 7 days, 45 days and 6 months post procedure
Device and Investigational Procedure Related Serious Adverse Events (SAE)
1 secondary outcome
Device success
Time frame: 45 days
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 17 Aug 2025.
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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.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEPIOLA System in people with Atrial Fibrillation, run by Endomatic Ltd. at 5 sites in 4 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Georgia, Lithuania, Poland, Uzbekistan. 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?
Contact Boaz Schwarz (+972 (0)544595839, boaz@endomaticmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SEPIOLA System Safety (time frame: 7 days, 45 days and 6 months post procedure). 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 17 Aug 2025.