Left Atrial Appendage ClosureADDLAAONCT06869811
Oral Anticoagulation Versus Left Atrial Appendage Occlusion Added to Direct Oral Anticoagulation in Patients with Stroke Despite Oral
A study testing LAA Closurse in people with Left Atrial Appendage Closure, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
A total of 380 patients with ischemic stroke despite OAC will be included. Patients will be randomized 1:1 to the best medical treatment (control) or the combination of LAAO and DOAC or OAC. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Left Atrial Appendage Closure
- What is being tested?
- LAA Closurse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jul 2024to 22 Jul 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardioembolic* Ischemic stroke despite OAC or DOAC within the last 6 months.
- Documented AF (either valvular or non-valvular AF).
- LAA suitable for closure (if LAA thrombus, just distal).
- Functional status at inclusion with no severe disability (mRS<4).
- No contraindication for LAA assessment by CT or 3D-TEE.
- >18 years
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- Life expectancy >1year
- Able to understand written consent prior to the trial inclusion.
- Able and willing to return for follow-up visits and tests.
Who cannot join
- Absolute contraindication to OAC/DOAC.
- Non-compliance of OAC/DOAC >24 hours within the last week before the index stroke (>1 dose per - - Antagonist Vit K and >2 doses per DOAC).
- Lacunar Ischemic Stroke.
- 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.
- 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).
- In the opinion of the investigator, is considered at high risk for general anesthesia and general anesthesia is planned for the study procedure.
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- Non-treated patent foramen ovale (PFO) or PFO closure device implanted.
- Inferior vena cava filter.
- 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).
- 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).
- LAA is obliterated or surgically ligated.
- Thrombocytopenia (defined as < 50,000 platelets per microliter (<50 x 109/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).
- Allergy to contrast media if the patient needs angio-CT and cannot undergo TEE/TOE.
- 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.
- 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 clinical investigation or to comply with follow up requirements, or impact the scientific soundness of the clinical investigation results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic Barcelona
Barcelona, Barcelona, 08036
Xavier Freixa, MD, PhD, 0034625942336, freixa@clinic.cat
Anna Campos, 0034934518746, acampos@clinic.cat
About this study
Official title: Oral Anticoagulation Versus Left Atrial Appendage Occlusion Added to Direct Oral Anticoagulation in Patients with Stroke Despite Oral (ADD-LAAO TRIAL)
A total of 380 patients with ischemic stroke despite OAC will be included. Patients will be randomized 1:1 to the best medical treatment (control) or the combination of LAAO and DOAC or OAC. The study's primary endpoint will be the occurrence of a cardioembolic event (ischemic stroke or arterial peripheral embolism) within the first 12 months after inclusion.
Read the detailed description
Background: The prevalence of atrial fibrillation and the number of patients experiencing ischemic strokes despite being on oral anticoagulation (OAC) are both increasing. This rise presents a significant challenge due to the absence of clear and uniform treatment recommendations for these patients. To date, there is no formal combination that merges a high anticoagulant efficacy while keeping a low bleeding risk. Transcatheter left atrial appendage occlusion (LAAO) added to OAC might provide a balance between efficacy and safety.
Objectives: To evaluate if, in patients with ischemic stroke despite OAC, the combination of LAAO and long-term direct OAC (DOAC) or OAC is associated with a lower incidence of recurrent cardioembolic events at 12 months as compared to the best medical treatment proposed by the neurologist.
Methods: A total of 380 patients with ischemic stroke despite OAC will be included. Patients will be randomized 1:1 to the best medical treatment (control) or the combination of LAAO and DOAC or OAC. The study's primary endpoint will be the occurrence of a cardioembolic event (ischemic stroke or arterial peripheral embolism) within the first 12 months after inclusion.
Implication: This study is one of the first randomized trials comparing the LAAO+DOAC combination to optimal medical treatment in patients who have had ischemic strokes despite being on OAC. If the results confirm the superiority of LAAO+DOAC, it could lead to a paradigm shift in treatment guidelines for these patients.
- Conditions
- Left Atrial Appendage Closure
- Being tested
- LAA Closurse
- Keywords
- LAAO, Stroke, Oral Anticoagulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAA ClosurseDevice
LAA Closure + DOAC or OAC
| Study group | Role | What they receive |
|---|---|---|
| Best medical treatment | Active comparator | The best medical treatment selected by the neurologist including change OAC/DOAC or intensification of the antithrombotic treatment. Receives: Device: LAA Closurse |
| Left atrial appendage occlusion + DOAC or OAC | Active comparator | LAA Occlusion + DOAC (unless there is a compelling use of OAC like in a mechanical valve). Receives: Device: LAA Closurse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
The study's primary endpoint will be the occurrence of a cardioembolic event (ischemic stroke or arterial peripheral embolism) within the first 12 months after inclusion.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start22 Jul 2024
- Primary completion22 Feb 2027 (estimated)
- Study completion22 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Atrial Appendage ClosureStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 arms Treatment vs. Procedure + treatment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital San Carlos, Madrid, Hospital Álvaro Cunqueiro, Hospital Universitari de Bellvitge, University of Salamanca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869811
- Sponsor's protocol ID
- ADD-LAAO
- Acronym
- ADDLAAO
- Status last verified
- Jul 2024
- First submitted
- 5 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Anticoagulation Versus Left Atrial Appendage Occlusion Added to Direct Oral Anticoagulation in Patients with Stroke Despite Oral (ADD-LAAO TRIAL)
- ClinicalTrials.gov ID
- NCT06869811
- Acronym / sponsor ID
- ADDLAAO / ADD-LAAO
- Conditions
- Left Atrial Appendage Closure
- Keywords
- LAAO, Stroke, Oral Anticoagulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital San Carlos, Madrid, Hospital Álvaro Cunqueiro, Hospital Universitari de Bellvitge, University of Salamanca
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 22 Feb 2027 (estimated)
- Study completion
- 22 Jul 2027 (estimated)
- First posted
- 11 Mar 2025 (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.
A total of 380 patients with ischemic stroke despite OAC will be included. Patients will be randomized 1:1 to the best medical treatment (control) or the combination of LAAO and DOAC or OAC. The study's primary endpoint will be the occurrence of a cardioembolic event (ischemic stroke or arterial peripheral embolism) within the first 12 months after inclusion.
Detailed description
Background: The prevalence of atrial fibrillation and the number of patients experiencing ischemic strokes despite being on oral anticoagulation (OAC) are both increasing. This rise presents a significant challenge due to the absence of clear and uniform treatment recommendations for these patients. To date, there is no formal combination that merges a high anticoagulant efficacy while keeping a low bleeding risk. Transcatheter left atrial appendage occlusion (LAAO) added to OAC might provide a balance between efficacy and safety.
Objectives: To evaluate if, in patients with ischemic stroke despite OAC, the combination of LAAO and long-term direct OAC (DOAC) or OAC is associated with a lower incidence of recurrent cardioembolic events at 12 months as compared to the best medical treatment proposed by the neurologist.
Methods: A total of 380 patients with ischemic stroke despite OAC will be included. Patients will be randomized 1:1 to the best medical treatment (control) or the combination of LAAO and DOAC or OAC. The study's primary endpoint will be the occurrence of a cardioembolic event (ischemic stroke or arterial peripheral embolism) within the first 12 months after inclusion.
Implication: This study is one of the first randomized trials comparing the LAAO+DOAC combination to optimal medical treatment in patients who have had ischemic strokes despite being on OAC. If the results confirm the superiority of LAAO+DOAC, it could lead to a paradigm shift in treatment guidelines for these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2 arms Treatment vs. Procedure + treatment
| Arm | Type | Receives |
|---|---|---|
| Best medical treatment | Active comparator | Device: LAA ClosurseThe best medical treatment selected by the neurologist including change OAC/DOAC or intensification of the antithrombotic treatment. |
| Left atrial appendage occlusion + DOAC or OAC | Active comparator | Device: LAA ClosurseLAA Occlusion + DOAC (unless there is a compelling use of OAC like in a mechanical valve). |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Cardioembolic* Ischemic stroke despite OAC or DOAC within the last 6 months.
- Documented AF (either valvular or non-valvular AF).
- LAA suitable for closure (if LAA thrombus, just distal).
- Functional status at inclusion with no severe disability (mRS<4).
- No contraindication for LAA assessment by CT or 3D-TEE.
Key exclusion criteria (22 listed)
- Absolute contraindication to OAC/DOAC.
- Non-compliance of OAC/DOAC >24 hours within the last week before the index stroke (>1 dose per - - Antagonist Vit K and >2 doses per DOAC).
- Lacunar Ischemic Stroke.
- 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.
- 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).
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 |
|---|---|---|
| LAA ClosurseLAA Closure + DOAC or OAC | Device | Best medical treatment, Left atrial appendage occlusion + DOAC or OAC |
Primary outcome
Primary Endpoint
Time frame: 12 months
The study's primary endpoint will be the occurrence of a cardioembolic event (ischemic stroke or arterial peripheral embolism) within the first 12 months after inclusion.
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 11 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LAA Closurse in people with Left Atrial Appendage Closure, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 9 inclusion and 22 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 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: 12 months). 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 11 Mar 2025.