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Peri-device Leakage Closure After LAAO

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04590898
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Cardiovascular Center Frankfurt

Brief 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.

Condition or disease Intervention/treatment
Atrial Fibrillation Stroke Bleeding Leakage of Cardiac Device Device: Peri-device leakage closure after left atrial appendage occlusion

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.

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Study Type : Observational
Estimated Enrollment : 85 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Safety and Feasibility of Peri-device Leakage Closure After Left Atrial Appendage Occlusion
Actual Study Start Date : September 27, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
significant peri-device leakage after LAA occlusion
Peri-device leakage closure after left atrial appendage occlusion
Device: Peri-device leakage closure after left atrial appendage occlusion
Peri-device leakage closure after left atrial appendage occlusion




Primary Outcome Measures :
  1. 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)

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Bleeding complications [ Time Frame: through study completion, an average of 1 year ]
    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)

  2. Vascular access site complications [ Time Frame: during procedure, assessed up to 7 days ]
    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

  3. Liver- and kidney failure associated with the procedure [ Time Frame: In-hospital stay, assessed up to 30days ]
    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

  4. Device-associated complications [ Time Frame: through study completion, an average of 1 year ]
    Number of participants experiencingdevice migration, perforation, laceration, erosion, device infection, pericarditis, device-related thrombus and persistent or occurrence of new peri-device leakage

  5. Ischemic stroke or transitory ischemic attack [ Time Frame: through study completion, an average of 1 year ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients after interventional or surgical left atrial appendage occlusion with severe leakage, who underwent interventional peri-device leakage closure
Criteria

Inclusion Criteria:

  • Patients after interventional or surgical left atrial appendage occlusion with severe leakage, who underwent interventional peri-device leakage closure

Exclusion Criteria:

  • n/a

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04590898


Contacts
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Contact: Sabine de Bruijn +49 69 9794 7653 s.debruijn@cvcfrankfurt.de
Contact: Kerstin Piayda +49 69 4603 1344 kerstinpiayda@gmail.com

Locations
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United States, Arizona
• Banner University Medical Center Phoenix Recruiting
Phoenix, Arizona, United States, 85006
United States, California
Scripps Health Recruiting
La Jolla, California, United States, 92037
United States, Kansas
Kansas City Heart Rhythm Institute Recruiting
Overland Park, Kansas, United States, 66211
United States, Minnesota
Mayo Clinic Hospital - Saint Mary's Campus Recruiting
Rochester, Minnesota, United States, 55902
United States, Tennessee
Vanderbilt Heart Institute Recruiting
Nashville, Tennessee, United States, 37212
United States, Texas
Austin Heart Recruiting
Austin, Texas, United States, 78756
United States, Utah
University of Utah Hospital Recruiting
Salt Lake City, Utah, United States, 84132
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Rigshospitalet Copenhagen Recruiting
Copenhagen, Denmark, 2100
Germany
Cardio Vascular Center Frankfurt Recruiting
Frankfurt, Hesse, Germany, 60389
Contact: Sabine de Bruijn    +496997947653    s.debruijn@cvcfrankfurt.de   
Contact: Kerstin Piayda    +496946031344    kerstinpiayda@gmail.com   
Principal Investigator: Horst Sievert         
Principal Investigator: Kerstin Piayda         
Universitätsklinikum Düsseldorf Recruiting
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF) Recruiting
Berlin, Germany, 12200
Poland
Poznan University of Medical Sciences Recruiting
Poznan, Poland, 61701
Spain
Hospital Universitario de Salamanca Recruiting
Salamanca, Spain, 37007
Switzerland
Inselspital Bern Recruiting
Bern, Switzerland, 3010
United Kingdom
Nuffield Health Recruiting
Headington, United Kingdom, OX3 7RP
Sponsors and Collaborators
Cardiovascular Center Frankfurt
Investigators
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Study Chair: Kerstin Piayda University Hospital Düsseldorf and Cardio Vascular Center Frankfurt
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Responsible Party: Cardiovascular Center Frankfurt
ClinicalTrials.gov Identifier: NCT04590898    
Other Study ID Numbers: CVC-002
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cardiovascular Center Frankfurt:
left atrial appendage occlusion
peri-device leakage
stroke
Additional relevant MeSH terms:
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Atrial Fibrillation
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes