Home
Clinical Trials
Therapy Strategies After LAA ...

Therapy Strategies After LAA Occluder Device Embolization

Last Updated: 2022-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-30

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Peri-device Leakage Closure After LAAO

NCT04590898

Atrial Fibrillation Stroke Bleeding +1 more

COMPLETED

Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation From Shanghai

NCT03987945

Atrial Fibrillation Left Atrial Appendage Occlusion

UNKNOWN

LAAO With DAPT Versus Antithrombotic Therapy

NCT03310801

Atrial Fibrillation Coronary Artery Disease

COMPLETED

Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients With Prohibitive Surgical Risk.

NCT05886517

Aortic Stenosis

RECRUITING NA

Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage

NCT02678871

Aortic Valve Disorder

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Left Atrial Appendage Occluder Device Embolisation Therapy Strategies Risk Factors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients experiencing device embolization after left atrial appendage occlusion

Device embolization following either surgical or interventional left atrial appendage occlusion

Removal or leaving of LAA occluders

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* n/a

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Dr. Horst Sievert

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sophie Eppinger

Role: PRINCIPAL_INVESTIGATOR

CardioVascular Center (CVC) Frankfurt, Seckbacher Landstraße 65, 60389 Frankfurt am Main, Hesse, Germany

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CardioVascular Center (CVC) Frankfurt

Frankfurt on the Main, Hesse, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CVC-003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CardioLogical Interventions and Acute strOke Treatment sTudy

NCT07314476 NOT_YET_RECRUITING

Safety and Efficacy of Left Atrial Appendage Closure Versus Antithrombotic Therapy in Patients With Atrial Fibrillation Undergoing Drug-Eluting Stent Implantation Due to Complex Coronary Artery Disease

NCT02606552 TERMINATED PHASE4

Impella Reverse Remodeling in End-Stage Heart Failure

NCT06800716 RECRUITING

Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter (AMTRAC) Valve Registry

NCT04031274 UNKNOWN

Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.

NCT04009434 UNKNOWN NA

Left Atrial Appendage Occlusion Registry (LAAO Registry)

NCT02699957 RECRUITING

Trajectories of Cardiac Allograft Vasculopathy After Heart Transplantation

NCT04117152 COMPLETED

Preprocedural Assessment of Anatomy and Device Sizing With CT and 3D Simulation in Left Atrial Appendage Occlusion.

NCT04640051 COMPLETED

Indication of Permanent Cardiac Parcing After Tanscatheter Aortic Valve Implantation

NCT02337140 COMPLETED NA

Elimination of Microemboli During Aortic Valve Replacement

NCT01128751 UNKNOWN NA

Impact of Mitral Regurgitation on Coronary Haemodynamics and Instantaneous Effect of Transcatheter Mitral Valve Repair

NCT04245956 TERMINATED NA

Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology

NCT03917563 UNKNOWN NA

A Prospective, Multicenter, Observational Study of the Safety and Efficacy of Emergency Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis

NCT07108478 NOT_YET_RECRUITING

Atrial Amyloid May Influence Outcomes in Patients Undergoing Surgical Aortic Valve Replacement

NCT07105501 COMPLETED

SAfe and Fast Discharge With Acurate Valve in Low Risk tavI Patients

NCT05983458 RECRUITING NA

Comprehensive CT-guided vs Echo-fluoroscopy-guided Strategy in the Left Atrial Appendage Occlusion

NCT04913207 UNKNOWN NA

Validation of Accurate Commissural Alignment During Transcatheter Aortic Valve Implantation

NCT05097183 UNKNOWN

Performance of Currently Available traNscaTHEter Aortic Valve Platforms in Inoperable Patients With Pure Aortic regurgitatiON of a Native Valve. The PANTHEON International Project.

NCT05319171 UNKNOWN

Cerebral Microembolization Associated With PFO Closure

NCT06347276 RECRUITING

Inflammatory Mediator Profiles During Heart Valve Replacement Surgery

NCT02727413 COMPLETED

Screening for Amyloidosis Before Aortic Valve Elective Replacement

NCT04869631 ACTIVE_NOT_RECRUITING

Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease

NCT07267117 RECRUITING

Cardiovalve Transfemoral System - FIM Study

NCT03958773 ENROLLING_BY_INVITATION NA

Cardiomyocyte Apoptosis Following Antegrade and Retrograde Cardioplegia

NCT01185912 COMPLETED

Accuracy of LAA Occluder Size Selection: CT vs. DSA During Combined AF Ablation and LAA Occlusion

NCT06455644 RECRUITING NA

Therapy Strategies After LAA Occluder Device Embolization

Study Results

Basic Information

Brief Summary

Related Clinical Trials

Peri-device Leakage Closure After LAAO

Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation From Shanghai

LAAO With DAPT Versus Antithrombotic Therapy

Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients With Prohibitive Surgical Risk.

Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage

Detailed Description

Conditions

Study Design

Study Groups

Patients experiencing device embolization after left atrial appendage occlusion

Removal or leaving of LAA occluders

Interventions

Removal or leaving of LAA occluders

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

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

Sheba Medical Center

Andrey Osadchiy, City Hospital #40, St. Petersburg, Russia

Andrey Kalemberg, National Research Center, Moscow, Russia

Jung-Sun Kim, Yonsei University Hospital, Seoul, South Korea

Aarhus University Hospital

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

Guy's and St Thomas' NHS Foundation Trust

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

Royal Victoria Hospital, Belfast

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