Therapy Strategies After LAA Occluder Device Embolization

Risk Factors Clinical Trial

— LAAODE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05014477
• Other study ID #: CVC-003
• Status: Active, not recruiting
• Start date: September 30, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2022
• Source: Cardiovascular Center Frankfurt
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Risk Factors

Intervention

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.

Locations

Country	Name	City	State
Germany	CardioVascular Center (CVC) Frankfurt	Frankfurt on the Main	Hesse

Sponsors (72)

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

Country where clinical trial is conducted

Germany, 

Outcome

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)