Atrial FibrillationNCT04590898
Peri-device Leakage Closure After LAAO
An observational study of Atrial Fibrillation and Stroke, run by Cardiovascular Center Frankfurt at 16 sites in 7 countries.
Trial summary
The investigators thought to evaluate the safety and feasibility of peri-device leakage closure after left atrial appendage occlusion (LAAO, either surgical or interventional) with different devices. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation, Stroke, Bleeding
- What is being tested?
- Peri-device leakage closure after left atrial appendage occlusion
- Type of treatment
- Medical device
- How many people
- 85 participants
- Where
- 16 sitesin 7 countries
- Study dates
- 27 Sep 2020to 1 Sep 2021
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after interventional or surgical left atrial appendage occlusion with severe leakage, who underwent interventional peri-device leakage closure
Who may be able to join
- Patients after interventional or surgical left atrial appendage occlusion with severe leakage, who underwent interventional peri-device leakage closure
Who cannot join
- n/a
Trial locations and contacts
16 sites in 7 countries.
16 sites in 7 countries
United States7 sites
Austin Heart
Austin, Texas, 78756
Scripps Health
La Jolla, California, 92037
Vanderbilt Heart Institute
Nashville, Tennessee, 37212
Kansas City Heart Rhythm Institute
Overland Park, Kansas, 66211
• Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
Mayo Clinic Hospital - Saint Mary's Campus
Rochester, Minnesota, 55902
University of Utah Hospital
Salt Lake City, Utah, 84132
Germany3 sites
Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
Berlin, 12200
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Cardio Vascular Center Frankfurt
Frankfurt am Main, Hesse, 60389
Denmark2 sites
Aarhus University Hospital
Aarhus, 8200
Rigshospitalet Copenhagen
Copenhagen, 2100
About this study
Official title: Safety and Feasibility of Peri-device Leakage Closure After Left Atrial Appendage Occlusion
The investigators thought to evaluate the safety and feasibility of peri-device leakage closure after left atrial appendage occlusion (LAAO, either surgical or interventional) with different devices.
Read the detailed description
The global burden of atrial fibrillation (AF) is high and thromboembolic stroke may be one of the fatal complications. Oral anticoagulation has been the mainstay therapy for decades to mitigate stroke risk. However, in poor candidates for long-term anticoagulation non-pharmacological stroke prevention with percutaneous left atrial appendage occlusion (LAAO) is a considerable treatment option. LAA shape and size varies widely and incomplete LAA closure or new leaks, due to LAA remodeling after the procedure, are observed in up to 30% of patients. Those leaks may cause turbulent flow and increase the risk for thrombus formation and subsequent thromboembolic events. However, the clinical significance after percutaneous LAAO has yet to be determined.
If significant leaks are present, patients usually remain on oral anticoagulation. In very few cases, an interventional approach is used to close peri-device leaks.
This is the first systematic study, trying to include a respectable number of patients who underwent peri-device leakage closure after LAAO. In this multi-center, collaborative study the investigators aim to identify different peri-device leak closure strategies with associated clinical outcomes and evaluate safety and feasibility of the procedure.
- Conditions
- Atrial Fibrillation, Stroke, Bleeding, Leakage of Cardiac Device
- Being tested
- Peri-device leakage closure after left atrial appendage occlusion
- Keywords
- left atrial appendage occlusion, peri-device leakage, stroke
- Medical subject headings
- Atrial Fibrillation, Stroke, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peri-device leakage closure after left atrial appendage occlusionDevice
Peri-device leakage closure after left atrial appendage occlusion
| Study group | Role | What they receive |
|---|---|---|
| significant peri-device leakage after LAA occlusion | Peri-device leakage closure after left atrial appendage occlusion Receives: Device: Peri-device leakage closure after left atrial appendage occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural mortality
Rate of all-cause mortality during the index procedure, number of participants experiencing a procedure-related death within 30days or during in-hospital stay for the index procedure (if>30days)
Measured: In-hospital stay, assessed up to 30days
Procedure-related clinically relevant pericardial effusion
Number of participants experiencing pericardial effusion with hemodynamic relevance, treated with therapeutic pericardiocentesis or surgical intervention, requiring blood transfusion or resulting in shock and/or death, which was procedure related
Measured: In-hospital stay, assessed up to 30days
Procedure-related ischemic stroke
Number of participants experiencing an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue, which was procedure related
Measured: In-hospital stay, assessed up to 30days
Secondary outcomes (5)
Bleeding complications
Number of participants experiencing bleeding complications evaluated by using VARC-2 criteria with LAAO specific modifications (after the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies)
Measured: through study completion, an average of 1 year
Vascular access site complications
Number of participants experiencing retroperitoneal haematoma, AV-fistula, arterial complications, venous complications, symptomatic peripheral ischemia, nerve injury with clinical symptoms >24h, vascular surgical repair at access site, pulmonary embolism, ipsilateral deep vein thrombosis, access site-related infection requiring iv. antibiotics or extended hospitalization
Measured: during procedure, assessed up to 7 days
Liver- and kidney failure associated with the procedure
Number of participants experiencing liver- and kidney failure potentially associated with the procedure evaluated by using the definitions of Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies
Measured: In-hospital stay, assessed up to 30days
Device-associated complications
Number of participants experiencingdevice migration, perforation, laceration, erosion, device infection, pericarditis, device-related thrombus and persistent or occurrence of new peri-device leakage
Measured: through study completion, an average of 1 year
Ischemic stroke or transitory ischemic attack
Number of participants experiencing an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue not directly related to the procedure
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start27 Sep 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiovascular Center Frankfurt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerstin Piayda, Study chair, University Hospital Düsseldorf and Cardio Vascular Center Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590898
- Sponsor's protocol ID
- CVC-002
- Status last verified
- Jul 2022
- First submitted
- 1 Oct 2020
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Peri-device Leakage Closure After Left Atrial Appendage Occlusion
- ClinicalTrials.gov ID
- NCT04590898
- Acronym / sponsor ID
- CVC-002
- Conditions
- Atrial Fibrillation, Stroke, Bleeding, Leakage of Cardiac Device
- Keywords
- left atrial appendage occlusion, peri-device leakage, stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Cardiovascular Center FrankfurtUniversity, hospital or other
- Study start
- 27 Sep 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 19 Oct 2020 (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 investigators thought to evaluate the safety and feasibility of peri-device leakage closure after left atrial appendage occlusion (LAAO, either surgical or interventional) with different devices.
Detailed description
The global burden of atrial fibrillation (AF) is high and thromboembolic stroke may be one of the fatal complications. Oral anticoagulation has been the mainstay therapy for decades to mitigate stroke risk. However, in poor candidates for long-term anticoagulation non-pharmacological stroke prevention with percutaneous left atrial appendage occlusion (LAAO) is a considerable treatment option. LAA shape and size varies widely and incomplete LAA closure or new leaks, due to LAA remodeling after the procedure, are observed in up to 30% of patients. Those leaks may cause turbulent flow and increase the risk for thrombus formation and subsequent thromboembolic events. However, the clinical significance after percutaneous LAAO has yet to be determined.
If significant leaks are present, patients usually remain on oral anticoagulation. In very few cases, an interventional approach is used to close peri-device leaks.
This is the first systematic study, trying to include a respectable number of patients who underwent peri-device leakage closure after LAAO. In this multi-center, collaborative study the investigators aim to identify different peri-device leak closure strategies with associated clinical outcomes and evaluate safety and feasibility of the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| significant peri-device leakage after LAA occlusion | – | Device: Peri-device leakage closure after left atrial appendage occlusionPeri-device leakage closure after left atrial appendage occlusion |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after interventional or surgical left atrial appendage occlusion with severe leakage, who underwent interventional peri-device leakage closure
Key inclusion criteria (1 listed)
- Patients after interventional or surgical left atrial appendage occlusion with severe leakage, who underwent interventional peri-device leakage closure
Key exclusion criteria (1 listed)
- n/a
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 |
|---|---|---|
| Peri-device leakage closure after left atrial appendage occlusionPeri-device leakage closure after left atrial appendage occlusion | Device | significant peri-device leakage after LAA occlusion |
Primary outcome
Procedural mortality
Time frame: In-hospital stay, assessed up to 30days
Rate of all-cause mortality during the index procedure, number of participants experiencing a procedure-related death within 30days or during in-hospital stay for the index procedure (if>30days)
Procedure-related clinically relevant pericardial effusion
Time frame: In-hospital stay, assessed up to 30days
Number of participants experiencing pericardial effusion with hemodynamic relevance, treated with therapeutic pericardiocentesis or surgical intervention, requiring blood transfusion or resulting in shock and/or death, which was procedure related
Procedure-related ischemic stroke
Time frame: In-hospital stay, assessed up to 30days
Number of participants experiencing an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue, which was procedure related
5 secondary outcomes
Bleeding complications
Time frame: through study completion, an average of 1 year
Vascular access site complications
Time frame: during procedure, assessed up to 7 days
Liver- and kidney failure associated with the procedure
Time frame: In-hospital stay, assessed up to 30days
Device-associated complications
Time frame: through study completion, an average of 1 year
Ischemic stroke or transitory ischemic attack
Time frame: through study completion, an average of 1 year
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 22 Jul 2022.
- 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. This study is not recruiting at the moment.
Kerstin Piayda study chair
University Hospital Düsseldorf and Cardio Vascular Center Frankfurt
16 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Stroke, run by Cardiovascular Center Frankfurt at 16 sites in 7 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 1 inclusion and 1 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 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Germany, Denmark, Poland, Spain and 2 more countries. 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?
Procedural mortality (time frame: In-hospital stay, assessed up to 30days). The study lists 3 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 22 Jul 2022.