Peri-device Leakage Closure After LAAO

NCT04590898 | Completed

• 1 other identifier: CVC-002
• Study Type: observational
• Target: 85
• Locations: 7 countries
• Sites: 16

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.

Conditions

Atrial Fibrillation; Stroke; Bleeding; Leakage of Cardiac Device

Keywords

left atrial appendage occlusion; peri-device leakage; stroke

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Bleeding complications

  through study completion, an average of 1 year

• Vascular access site complications

  during procedure, assessed up to 7 days

• Liver- and kidney failure associated with the procedure

  In-hospital stay, assessed up to 30days

• Device-associated complications

  through study completion, an average of 1 year

• Ischemic stroke or transitory ischemic attack

  through study completion, an average of 1 year

Study Arms (1)

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

Interventions

Peri-device leakage closure after left atrial appendage occlusion DEVICE

Peri-device leakage closure after left atrial appendage occlusion

significant peri-device leakage after LAA occlusion

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• n/a

Sponsors & Collaborators

• Cardiovascular Center Frankfurt: lead

Study Sites (16)

• Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Scripps Health

La Jolla, California, 92037, United States

Location

Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

Location

Mayo Clinic Hospital - Saint Mary's Campus

Rochester, Minnesota, 55902, United States

Location

Vanderbilt Heart Institute

Nashville, Tennessee, 37212, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Rigshospitalet Copenhagen

Copenhagen, 2100, Denmark

Location

Cardio Vascular Center Frankfurt

Frankfurt am Main, Hesse, 60389, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)

Berlin, 12200, Germany

Location

Poznan University of Medical Sciences

Poznan, 61701, Poland

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

Nuffield Health

Headington, OX3 7RP, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Hemorrhage

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Kerstin Piayda

  University Hospital Düsseldorf and Cardio Vascular Center Frankfurt

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 19, 2020
• Study Start: September 27, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

CH (1); ES (1); US (7); DK (2); GB (1); DE (3); PL (1)