Clinical trial NCT05014477: Therapy Strategies After LAA Occluder Device Embolization
Official title: Device Embolization After Percutaneous Left Atrial Appendage Occlusion: Risk Factors, Approaches and Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Left Atrial Appendage Occluder
Device Embolisation
Therapy Strategies
Risk Factors
Keywords: left atrial appendage occluder
device embolization
therapy strategy
risk factors
Lead sponsor: Cardiovascular Center Frankfurt
Sponsor class: OTHER
Collaborators: name: Kerstin Piayda, CardioVascular Center Frankfurt, Frankfurt, Germany
name: Kolja Sievert, CardioVascular Center Frankfurt, Frankfurt, Germany
name: Roberto Galea, Universitätsspital Bern, Bern, Switzerland
name: Moniek Maarse, St. Antonius Ziekenhuis, Nieuwegein, Netherlands
name: Sheba Medical Center
name: Andrey Osadchiy, City Hospital #40, St. Petersburg, Russia
name: Andrey Kalemberg, National Research Center, Moscow, Russia
name: Jung-Sun Kim, Yonsei University Hospital, Seoul, South Korea
name: Aarhus University Hospital
name: Sajjad A Sabir, Cooper University Hospital, NJ, USA
name: Ashish Pershad, Banner Health, Phoenix, Arizona, USA
name: Markus Sandri, Herzzentrum Leipzig, Leipzig, Germany
name: Jens-Erik Nielsen-Kudsk, University Hospital Aarhus, Aarhus, Denmark
name: George Mark, The Heart House/Cooper University Camden, NJ, USA
name: Dhiraj Gupta, Liverpool Heart and Chest Hospital, Liverpool, UK
name: Pradhum Ram, Emory University, USA
name: Ole de Backer, Rigshospitalet Copenhagen, Denmark
name: Norbert Klein, Klinikum St. Georg, Leipzig, Germany
name: Josep Rodes, Laval Hospital, Quebec, Canada
name: Shazia Afzal, Heinrich-Heine University, University Hospital, Duesseldorf
name: Xavier Millán Alvarez, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
name: James E. Harvey, WellSpan Health, York, PA, USA
name: Wern Yew Ding, University of Liverpool, Liverpool, UK
name: Adel Aminian, Centre hospitalier universitaire de Charleroi, Brussels, Belgium
name: Pamela Moceri, Hopital Pasteur 1, Nice, France
name: Ibrahim Akin, Universitätsmedizin Mannheim, Germany
name: Jacques Mansourati, Hôpital de la Cavale Blanche, Brest, France
name: Eloi Marijon, Hôpital Européen Georges-Pompidou HEGP, Paris, France
name: Ignacio Amat Santos, University Clinical Hospital of Valladolid, Valladolid, Spain
name: Hana Vaknin Assa, Beilinson Hospital, Israel
name: Thomas Robert Schmidt, Herzzentrum Dresden GmbH Universitätsklinik, Dresden, Germany
name: Ran Kornowski, Rabin Medical Center, Petah Tiqwa, Israel
name: Giacomo Boccuzzi, Ospedale san Giovanni Bosco, Torino, Italy
name: Christopher R. Ellis, Vanderbilt University, Nashville, TN, USA
name: Henning Ebelt, Katholisches Krankenhaus St. Nepomuk, Erfurt, Germany
name: Guy's and St Thomas' NHS Foundation Trust
name: Sonja Lehmann, Hôpital Fribourgeois, Freiburg, Swizerland
name: Oh-Hyun Lee, Yonsai University Hospital, Yongin, Korea
name: Wendy Schell, Cooper University Hospital, NJ, USA
name: Domenico della Rocca, St David's Medical Center, Austin, Texas, USA
name: Pablo Pinon Esteban, Hospital Universitario A Coruña, Spain
name: Jose Gabriel Galache Osuna, Miguel Servet University Hospital, Zaragoza, Spain
name: Enio Guerios, Hospital Pilar, Curitiba, Brazil
name: Nicolas Amabile, Institut Mutualiste Montsouris, Paris, France
name: Ignacio Cruz Gonzalez, University Hospital of Salamanca, Castillay Leon, Spain
name: Weita Chen, Taipei Municipal Wanfang Hospital, Taipei, Taiwan
name: Sandeep Kumar Goyal, Piedmont Heart Institute Buckhead, Atlanta, GA, USA
name: Francesco Gianni, Maria Cecilia Hospital, Cotignola, Italy
name: Máximo Rivero Ayerza, Ziekenhuis Oost Limburg, Genk, Belgium
name: Carsten Skurk, Charité, Universitätsmedizin Berlin, Berlin, Germany
name: Martin Langel, Klinikum St. Georg, Leipzig, Germany
name: Livia Gheorghe, Hospital de la Santa Creu I Santa Pau, Barcelona, Spain
name: Lino Santos, Centro Hospitalar Vila Nova de Gaia, Vila Nova de Gaia, Portugal
name: Royal Victoria Hospital, Belfast
name: Luis Nombela-Franco, Hospital Clínico San Carlos, Madrid, Spain
name: Francesco Nappi, Centre Cardiologique du Nord de Saint-Denis, Paris, France
name: Matteo Montorfano, Ospedale San Raffaele, Segrate, Milan, Italy
name: Juan Fernández-Armenta, Hospital Universitario Puerta del Mar, Cádiz, Spain
name: Michael Kühne, Universitätsspital Basel, Basel, Swizerland
name: Jesper van der Pals, Lund University Hospital, Lund, Sweden.
name: Can Yücel Karabay, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Center, Istanbul, Turkey
name: Marco Ancona, San Raffaele Scientific Institute, Milan, Italy
name: Ghassan Moubarak, Clinique Ambroise Paré, Neuilly-sur-Seine, France
name: Tom De Potter, OLV Hospital, Aalst, Belgium
name: Mathieu Lempereur, CHU de Liège, Belgium
name: Clinton Health Access Initiative Inc.
name: Evgeny Merkulov, Scientific Research Center, Moscow, Russia
name: Liesbeth Rosseel, ASZ Aalst, Belgium
name: Antti Saraste, Heart Center, Turku University Hospital, Turku, Finland
name: Ahmet Güner, Mehmet Akif Ersoy Hospital, Turkey
name: Achille Gaspardone, San Eugenio Hospital ASL Roma, Italy
First posted: 2021-08-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after interventional or surgical left atrial appendage occlusion with device embolization

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

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Procedural mortality
timeFrame: In-hospital stay, assessed up to 30 days
measure: Need for cardiac surgery
timeFrame: In-hospital stay, assessed up to 30 days
measure: Catheter-based retrieval of LAA Occluder
timeFrame: up to 5 years (after device implantation)
Secondary outcomes:
measure: Further complications
timeFrame: up to 5 years (after device implantation)
measure: Risk factors
timeFrame: up to 30 days (after device implantation)
Other outcomes:
Locations:
city: Frankfurt on the Main
country: Germany
facility: CardioVascular Center (CVC) Frankfurt
state: Hesse
Study officials:
affiliation: CardioVascular Center (CVC) Frankfurt, Seckbacher Landstraße 65, 60389 Frankfurt am Main, Hesse, Germany
name: Sophie Eppinger
role: PRINCIPAL_INVESTIGATOR
References: