NCT02830152Active, not recruiting
Prevention of Stroke by Left Atrial Appendage Closure in Atrial Fibrillation Patients After Intracerebral Hemorrhage
Prevention of Stroke by Left Atrial Appendage Closure in Atrial Fibrillation Patients After Intracerebral Hemorrhage: A Multicenter Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 12 Jun 2024
Brief summary (registry, in English)
Intracerebral hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) poses a particular dilemma for thromboprophylaxis. Left atrial appendage occlusion (LAAO) is a non-pharmacological approach to prevent cardiac embolism in NVAF. The risk-benefit ratio of LAAO in patients with NVAF after ICH is unknown. The aim of STROKECLOSE is to assess the effect of LAAO to reduce the incidence stroke, bleeding and cardiovascular mortality in patients with NVAF and prior ICH.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 750 (estimated)
- First submitted
- 29 Jun 2016
- Start date
- May 2017
- Primary completion date
- Dec 2027
- Lead sponsor
- Karolinska Institutet
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT02830152
What you commit to
- Study type: Interventional
- Planned participants: 750
- From May 2017 to the primary completion date, Dec 2027
- 17 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior surgical LAA excision
Other
- ICH secondary to vascular malformation or tumors
- Estimated life expectancy of less than 1 year at eligibility assessment
- mRS \> 3 at enrollment
- Planned combined interventional procedures at the time of enrollment
Who the study is looking for
- A diagnosis of paroxysmal, persistent or long-standing NVAF with CHA2DS2VASc score \>2.
- Clinical and CT/MRI evidence of ICH within 12 months but not less than 4 weeks prior to enrollment.
- Age \> 18 years.
- Signed informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Bispebjerg University Hospital Coordinator of this site? Confirm its status | Bispebjerg | Denmark | Unknown status |
| Rikshospitalet Glostrup Coordinator of this site? Confirm its status | Glostrup Municipality | Denmark | Unknown status |
| Herlev sjukhus Coordinator of this site? Confirm its status | Herlev | Denmark | Unknown status |
| Odenses Universitetssjukhus Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
| Helsinki University Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
| North Karelia Central Hospital Coordinator of this site? Confirm its status | Joensuu | Finland | Unknown status |
| Kuopio University Hospital Coordinator of this site? Confirm its status | Kuopio | Finland | Unknown status |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Unknown status |
| Vaasa Centralsjukhus Coordinator of this site? Confirm its status | Vaasa | Finland | Unknown status |
| Haukeland Universitetssjukhus Coordinator of this site? Confirm its status | Bergen | Norway | Unknown status |
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Sahlgrenska University Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Universitetssjukhuset Skåne Coordinator of this site? Confirm its status | Lund | Sweden | Unknown status |
| Universitetssjukhuset Coordinator of this site? Confirm its status | Örebro | Sweden | Unknown status |
| Danderyd Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Akademiska sjukhuset Coordinator of this site? Confirm its status | Uppsala | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.