Risk Factors Clinical Trial
— LAAODEOfficial title:
Device Embolization After Percutaneous Left Atrial Appendage Occlusion: Risk Factors, Approaches and Outcomes
Verified date | July 2022 |
Source | Cardiovascular Center Frankfurt |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The investigators thought to evaluate risk factors, therapeutic approaches and outcomes after left atrial appendage occluder device embolization (LAAO, either surgical or interventional).
Status | Active, not recruiting |
Enrollment | 400 |
Est. completion date | December 31, 2023 |
Est. primary completion date | September 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Patients after interventional or surgical left atrial appendage occlusion with device embolization Exclusion Criteria: - n/a |
Country | Name | City | State |
---|---|---|---|
Germany | CardioVascular Center (CVC) Frankfurt | Frankfurt on the Main | Hesse |
Lead Sponsor | Collaborator |
---|---|
Cardiovascular Center Frankfurt | Achille Gaspardone, San Eugenio Hospital ASL Roma, Italy, Adel Aminian, Centre hospitalier universitaire de Charleroi, Brussels, Belgium, Ahmet Güner, Mehmet Akif Ersoy Hospital, Turkey, Andrey Kalemberg, National Research Center, Moscow, Russia, Andrey Osadchiy, City Hospital #40, St. Petersburg, Russia, Antti Saraste, Heart Center, Turku University Hospital, Turku, Finland, Ashish Pershad, Banner Health, Phoenix, Arizona, USA, Avi Sabbag, Chaim Sheba Medical Center, Tel Hashomer, Israel, Brian Clapp, Guy's and St Thomas' NHS Foundation Trust, London, UK, Can Yücel Karabay, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Center, Istanbul, Turkey, Carsten Skurk, Charité, Universitätsmedizin Berlin, Berlin, Germany, Christopher R. Ellis, Vanderbilt University, Nashville, TN, USA, Dhiraj Gupta, Liverpool Heart and Chest Hospital, Liverpool, UK, Domenico della Rocca, St David's Medical Center, Austin, Texas, USA, Eloi Marijon, Hôpital Européen Georges-Pompidou HEGP, Paris, France, Enio Guerios, Hospital Pilar, Curitiba, Brazil, Evgeny Merkulov, Scientific Research Center, Moscow, Russia, Francesco Gianni, Maria Cecilia Hospital, Cotignola, Italy, Francesco Nappi, Centre Cardiologique du Nord de Saint-Denis, Paris, France, George Mark, The Heart House/Cooper University Camden, NJ, USA, Ghassan Moubarak, Clinique Ambroise Paré, Neuilly-sur-Seine, France, Giacomo Boccuzzi, Ospedale san Giovanni Bosco, Torino, Italy, Hana Vaknin Assa, Beilinson Hospital, Israel, Henning Ebelt, Katholisches Krankenhaus St. Nepomuk, Erfurt, Germany, Ibrahim Akin, Universitätsmedizin Mannheim, Germany, Ignacio Amat Santos, University Clinical Hospital of Valladolid, Valladolid, Spain, Ignacio Cruz Gonzalez, University Hospital of Salamanca, Castillay Leon, Spain, Jacques Mansourati, Hôpital de la Cavale Blanche, Brest, France, James E. Harvey, WellSpan Health, York, PA, USA, Jens-Erik Nielsen-Kudsk, University Hospital Aarhus, Aarhus, Denmark, Jesper van der Pals, Lund University Hospital, Lund, Sweden., Joelle Kefer, Cliniques universitaires Saint-Luc, Bruxelles, Belgium, Jose Gabriel Galache Osuna, Miguel Servet University Hospital, Zaragoza, Spain, Josep Rodes, Laval Hospital, Quebec, Canada, Juan Fernández-Armenta, Hospital Universitario Puerta del Mar, Cádiz, Spain, Jung-Sun Kim, Yonsei University Hospital, Seoul, South Korea, Kasper Korsholm, Aarhus University Hospital, Aarhus, Denmark, Kerstin Piayda, CardioVascular Center Frankfurt, Frankfurt, Germany, Kolja Sievert, CardioVascular Center Frankfurt, Frankfurt, Germany, Liesbeth Rosseel, ASZ Aalst, Belgium, Lino Santos, Centro Hospitalar Vila Nova de Gaia, Vila Nova de Gaia, Portugal, Livia Gheorghe, Hospital de la Santa Creu I Santa Pau, Barcelona, Spain, Luis Nombela-Franco, Hospital Clínico San Carlos, Madrid, Spain, Marco Ancona, San Raffaele Scientific Institute, Milan, Italy, Mark Spence, Royal Victoria Hospital, Belfast Trust, Belfast, UK, Markus Sandri, Herzzentrum Leipzig, Leipzig, Germany, Martin Langel, Klinikum St. Georg, Leipzig, Germany, Mathieu Lempereur, CHU de Liège, Belgium, Matteo Montorfano, Ospedale San Raffaele, Segrate, Milan, Italy, Máximo Rivero Ayerza, Ziekenhuis Oost Limburg, Genk, Belgium, Michael Kühne, Universitätsspital Basel, Basel, Swizerland, Moniek Maarse, St. Antonius Ziekenhuis, Nieuwegein, Netherlands, Nicolas Amabile, Institut Mutualiste Montsouris, Paris, France, Norbert Klein, Klinikum St. Georg, Leipzig, Germany, Oh-Hyun Lee, Yonsai University Hospital, Yongin, Korea, Ole de Backer, Rigshospitalet Copenhagen, Denmark, Pablo Pinon Esteban, Hospital Universitario A Coruña, Spain, Pamela Moceri, Hopital Pasteur 1, Nice, France, Pradhum Ram, Emory University, USA, Ran Kornowski, Rabin Medical Center, Petah Tiqwa, Israel, Roberto Galea, Universitätsspital Bern, Bern, Switzerland, Sajjad A Sabir, Cooper University Hospital, NJ, USA, Sandeep Kumar Goyal, Piedmont Heart Institute Buckhead, Atlanta, GA, USA, Shazia Afzal, Heinrich-Heine University, University Hospital, Duesseldorf, Sonja Lehmann, Hôpital Fribourgeois, Freiburg, Swizerland, Thomas Robert Schmidt, Herzzentrum Dresden GmbH Universitätsklinik, Dresden, Germany, Tom De Potter, OLV Hospital, Aalst, Belgium, Weita Chen, Taipei Municipal Wanfang Hospital, Taipei, Taiwan, Wendy Schell, Cooper University Hospital, NJ, USA, Wern Yew Ding, University of Liverpool, Liverpool, UK, Xavier Millán Alvarez, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Need for cardiac surgery | In-hospital stay, assessed up to 30 days | ||
Primary | Catheter-based retrieval of LAA Occluder | peri-procedural device removal | up to 5 years (after device implantation) | |
Secondary | Further complications | Any other complications after device embolization (i.e., thromboembolic events, circulatory problems, CPR etc.) | up to 5 years (after device implantation) | |
Secondary | 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) |
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