Therapy Strategies After LAA Occluder Device Embolization (LAAODE)

Device Embolization After Percutaneous Left Atrial Appendage Occlusion: Risk Factors, Approaches and Outcomes

The investigators thought to evaluate risk factors, therapeutic approaches and outcomes after left atrial appendage occluder device embolization (LAAO, either surgical or interventional).

Study Overview

• Status: Active, not recruiting
• Conditions: Risk Factors; Left Atrial Appendage Occluder; Device Embolisation; Therapy Strategies
• Intervention / Treatment: Procedure: Removal or leaving of LAA occluders

Detailed Description

The global burden of atrial fibrillation (AF) is high, and AF represents a major cause of morbidity, mortality and health-care expenditure. Thromboembolic stroke may be one of the fatal complications and oral anticoagulation has been the mainstay therapy for decades to mitigate stroke risk. However, in poor candidates for long-term anticoagulation (i.e. high bleeding risk, poor drug tolerance or adherence), non- pharmacological stroke prevention with percutaneous left atrial appendage occlusion (LAAO) is a considerable treatment option.

Occluders are implanted into the left atrial appendage (LAA) but they might dislocate and therefore embolize subsequently. In this case, surgical or percutaneous removal of the device may be indicated. Depending on the patient's status, implanting another device can be an alternative to returning to anticoagulation.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Germany
  • Hesse
    • Frankfurt on the Main, Hesse, Germany, 60389
      • CardioVascular Center (CVC) Frankfurt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 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 device embolization

Description

Inclusion Criteria:

• Patients after interventional or surgical left atrial appendage occlusion with device embolization

Exclusion Criteria:

• n/a

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients experiencing device embolization after left atrial appendage occlusion; Device embolization following either surgical or interventional left atrial appendage occlusion	Procedure: Removal or leaving of LAA occluders; After LAA device embolization there are different approaches to dealing with the occluder dislocation. The aim is to find out which way leads to the best outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural mortality	all-cause mortality during the index procedure, any procedure-related death within 30days or during in-hospital stay for the index procedure (if>30days)	In-hospital stay, assessed up to 30 days
Need for cardiac surgery		In-hospital stay, assessed up to 30 days
Catheter-based retrieval of LAA Occluder	peri-procedural device removal	up to 5 years (after device implantation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Further complications	Any other complications after device embolization (i.e., thromboembolic events, circulatory problems, CPR etc.)	up to 5 years (after device implantation)
Risk factors	Favoring conditions for LAAO device dislocation (e.g., anatomical risk factors, risk factors related to the initial procedure)	up to 30 days (after device implantation)

Collaborators and Investigators

• Sponsor: Cardiovascular Center Frankfurt
• Collaborators: Sheba Medical Center; Kerstin Piayda, CardioVascular Center Frankfurt, Frankfurt, Germany; Kolja Sievert, CardioVascular Center Frankfurt, Frankfurt, Germany; Roberto Galea, Universitätsspital Bern, Bern, Switzerland; Moniek Maarse, St. Antonius Ziekenhuis, Nieuwegein, Netherlands; Andrey Osadchiy, City Hospital #40, St. Petersburg, Russia; Andrey Kalemberg, National Research Center, Moscow, Russia; Jung-Sun Kim, Yonsei University Hospital, Seoul, South Korea; Kasper Korsholm, Aarhus University Hospital, Aarhus, Denmark; Sajjad A Sabir, Cooper University Hospital, NJ, USA; Ashish Pershad, Banner Health, Phoenix, Arizona, USA; Markus Sandri, Herzzentrum Leipzig, Leipzig, Germany; Jens-Erik Nielsen-Kudsk, University Hospital Aarhus, Aarhus, Denmark; George Mark, The Heart House/Cooper University Camden, NJ, USA; Dhiraj Gupta, Liverpool Heart and Chest Hospital, Liverpool, UK; Pradhum Ram, Emory University, USA; Ole de Backer, Rigshospitalet Copenhagen, Denmark; Norbert Klein, Klinikum St. Georg, Leipzig, Germany; Josep Rodes, Laval Hospital, Quebec, Canada; Shazia Afzal, Heinrich-Heine University, University Hospital, Duesseldorf; Xavier Millán Alvarez, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; James E. Harvey, WellSpan Health, York, PA, USA; Wern Yew Ding, University of Liverpool, Liverpool, UK; Adel Aminian, Centre hospitalier universitaire de Charleroi, Brussels, Belgium; Pamela Moceri, Hopital Pasteur 1, Nice, France; Ibrahim Akin, Universitätsmedizin Mannheim, Germany; Jacques Mansourati, Hôpital de la Cavale Blanche, Brest, France; Eloi Marijon, Hôpital Européen Georges-Pompidou HEGP, Paris, France; Ignacio Amat Santos, University Clinical Hospital of Valladolid, Valladolid, Spain; Hana Vaknin Assa, Beilinson Hospital, Israel; Thomas Robert Schmidt, Herzzentrum Dresden GmbH Universitätsklinik, Dresden, Germany; Ran Kornowski, Rabin Medical Center, Petah Tiqwa, Israel; Giacomo Boccuzzi, Ospedale san Giovanni Bosco, Torino, Italy; Christopher R. Ellis, Vanderbilt University, Nashville, TN, USA; Henning Ebelt, Katholisches Krankenhaus St. Nepomuk, Erfurt, Germany; Brian Clapp, Guy's and St Thomas' NHS Foundation Trust, London, UK; Sonja Lehmann, Hôpital Fribourgeois, Freiburg, Swizerland; Oh-Hyun Lee, Yonsai University Hospital, Yongin, Korea; Wendy Schell, Cooper University Hospital, NJ, USA; Domenico della Rocca, St David's Medical Center, Austin, Texas, USA; Pablo Pinon Esteban, Hospital Universitario A Coruña, Spain; Jose Gabriel Galache Osuna, Miguel Servet University Hospital, Zaragoza, Spain; Enio Guerios, Hospital Pilar, Curitiba, Brazil; Nicolas Amabile, Institut Mutualiste Montsouris, Paris, France; Ignacio Cruz Gonzalez, University Hospital of Salamanca, Castillay Leon, Spain; Weita Chen, Taipei Municipal Wanfang Hospital, Taipei, Taiwan; Sandeep Kumar Goyal, Piedmont Heart Institute Buckhead, Atlanta, GA, USA; Francesco Gianni, Maria Cecilia Hospital, Cotignola, Italy; Máximo Rivero Ayerza, Ziekenhuis Oost Limburg, Genk, Belgium; Carsten Skurk, Charité, Universitätsmedizin Berlin, Berlin, Germany; Martin Langel, Klinikum St. Georg, Leipzig, Germany; Livia Gheorghe, Hospital de la Santa Creu I Santa Pau, Barcelona, Spain; Lino Santos, Centro Hospitalar Vila Nova de Gaia, Vila Nova de Gaia, Portugal; Mark Spence, Royal Victoria Hospital, Belfast Trust, Belfast, UK; Luis Nombela-Franco, Hospital Clínico San Carlos, Madrid, Spain; Francesco Nappi, Centre Cardiologique du Nord de Saint-Denis, Paris, France; Matteo Montorfano, Ospedale San Raffaele, Segrate, Milan, Italy; Juan Fernández-Armenta, Hospital Universitario Puerta del Mar, Cádiz, Spain; Michael Kühne, Universitätsspital Basel, Basel, Swizerland; Jesper van der Pals, Lund University Hospital, Lund, Sweden.; Can Yücel Karabay, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Center, Istanbul, Turkey; Marco Ancona, San Raffaele Scientific Institute, Milan, Italy; Ghassan Moubarak, Clinique Ambroise Paré, Neuilly-sur-Seine, France; Tom De Potter, OLV Hospital, Aalst, Belgium; Mathieu Lempereur, CHU de Liège, Belgium; Joelle Kefer, Cliniques universitaires Saint-Luc, Bruxelles, Belgium; Evgeny Merkulov, Scientific Research Center, Moscow, Russia; Liesbeth Rosseel, ASZ Aalst, Belgium; Antti Saraste, Heart Center, Turku University Hospital, Turku, Finland; Ahmet Güner, Mehmet Akif Ersoy Hospital, Turkey; Achille Gaspardone, San Eugenio Hospital ASL Roma, Italy
• Investigators: Principal Investigator: Sophie Eppinger, CardioVascular Center (CVC) Frankfurt, Seckbacher Landstraße 65, 60389 Frankfurt am Main, Hesse, Germany

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: risk factors; left atrial appendage occluder; device embolization; therapy strategy
• Other Study ID Numbers: CVC-003

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