Peri-device Leakage Closure After LAAO

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Atrial Fibrillation; Bleeding; Leakage of Cardiac Device
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital
  • Copenhagen, Denmark, 2100
    • Rigshospitalet Copenhagen
• Germany
  • Berlin, Germany, 12200
    • Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
  • Hesse
    • Frankfurt, Hesse, Germany, 60389
      • Cardio Vascular Center Frankfurt
  • North Rhine-Westphalia
    • Düsseldorf, North Rhine-Westphalia, Germany, 40225
      • Universitätsklinikum Düsseldorf
• Poland
  • Poznan, Poland, 61701
    • Poznan University of Medical Sciences
• Spain
  • Salamanca, Spain, 37007
    • Hospital Universitario de Salamanca
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern
• United Kingdom
  • Headington, United Kingdom, OX3 7RP
    • Nuffield Health
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • • Banner University Medical Center Phoenix
  • California
    • La Jolla, California, United States, 92037
      • Scripps Health
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Kansas City Heart Rhythm Institute
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic Hospital - Saint Mary's Campus
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt Heart Institute
  • Texas
    • Austin, Texas, United States, 78756
      • Austin Heart
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	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	In-hospital stay, assessed up to 30days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	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	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	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	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Cardiovascular Center Frankfurt
• Investigators: Study Chair: Kerstin Piayda, University Hospital Düsseldorf and Cardio Vascular Center Frankfurt

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2020
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: October 1, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: stroke; left atrial appendage occlusion; peri-device leakage
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CVC-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No