Left Atrial Appendage OccluderLAAODENCT05014477
Therapy Strategies After LAA Occluder Device Embolization
An observational study of Left Atrial Appendage Occluder and Device Embolisation, run by Cardiovascular Center Frankfurt at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Left Atrial Appendage Occluder, Device Embolisation, Therapy Strategies
- What is being tested?
- Removal or leaving of LAA occluders
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- 30 Sep 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after interventional or surgical left atrial appendage occlusion with device embolization
Who may be able to join
- Patients after interventional or surgical left atrial appendage occlusion with device embolization
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
Germany1 site
CardioVascular Center (CVC) Frankfurt
Frankfurt on the Main, Hesse, 60389
About this study
Official title: 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).
Read the 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.
- Being tested
- Removal or leaving of LAA occluders
- Keywords
- left atrial appendage occluder, device embolization, therapy strategy, risk factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removal or leaving of LAA occludersProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients experiencing device embolization after left atrial appendage occlusion | Device embolization following either surgical or interventional left atrial appendage occlusion Receives: Procedure: Removal or leaving of LAA occluders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: In-hospital stay, assessed up to 30 days
Need for cardiac surgery
Measured: In-hospital stay, assessed up to 30 days
Catheter-based retrieval of LAA Occluder
peri-procedural device removal
Measured: up to 5 years (after device implantation)
Secondary outcomes (2)
Further complications
Any other complications after device embolization (i.e., thromboembolic events, circulatory problems, CPR etc.)
Measured: 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)
Measured: up to 30 days (after device implantation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start30 Sep 2020
- Primary completion30 Sep 2021
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left Atrial Appendage OccluderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiovascular Center Frankfurt
- Sponsor type
- University, hospital or other
- Collaborators
- 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, Liverpool Heart and Chest Hospital NHS Foundation Trust, Pradhum Ram, Emory University, USA, Copenhagen University Hospital, Rigshospitalet, 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, Vanderbilt University, 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, 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, Centre Hospitalier Universitaire de Liege, Clinton Health Access Initiative Inc., 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
- Responsible party
- Principal investigator, Prof. Dr. Horst Sievert, Cardiovascular Center Frankfurt
- Investigators
- Sophie Eppinger, Principal investigator, CardioVascular Center (CVC) Frankfurt, Seckbacher Landstraße 65, 60389 Frankfurt am Main, Hesse, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014477
- Sponsor's protocol ID
- CVC-003
- Acronym
- LAAODE
- Status last verified
- Jul 2022
- First submitted
- 12 Aug 2021
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Eppinger S, Piayda K, Galea R, Sandri M, Maarse M, Guner A, Karabay CY, Pershad A, Ding WY, Aminian A, Akin I, Davtyan KV, Chugunov IA, Marijon E, Rosseel L, Schmidt TR, Amabile N, Korsholm K, Lund J, Guerios E, Amat-Santos IJ, Boccuzzi G, Ellis CR, Sabbag A, Ebelt H, Clapp B, Assa HV, Levi A, Ledwoch J, Lehmann S, Lee OH, Mark G, Schell W, Della Rocca DG, Natale A, de Backer O, Kefer J, Esteban PP, Abelson M, Ram P, Moceri P, Galache Osuna JG, Alvarez XM, Cruz-Gonzalez I, de Potter T, Ghassan M, Osadchiy A, Chen W, Goyal SK, Giannini F, Rivero-Ayerza M, Afzal S, Jung C, Skurk C, Langel M, Spence M, Merkulov E, Lempereur M, Shin SY, Mesnier J, McKinney HL, Schuler BT, Armero S, Gheorghe L, Ancona MBM, Santos L, Mansourati J, Nombela-Franco L, Nappi F, Kuhne M, Gaspardone A, van der Pals J, Montorfano M, Fernandez-Armenta J, Harvey JE, Rodes-Cabau J, Klein N, Sabir SA, Kim JS, Cook S, Kornowski R, Saraste A, Nielsen-Kudsk JE, Gupta D, Boersma L, Raber L, Sievert K, Sievert H, Bertog S. Embolization of percutaneous left atrial appendage closure devices: Timing, management and clinical outcomes. Cardiovasc Revasc Med. 2024 Jul;64:7-14. doi: 10.1016/j.carrev.2024.02.014. Epub 2024 Feb 28.
PubMed 38448258
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Device Embolization After Percutaneous Left Atrial Appendage Occlusion: Risk Factors, Approaches and Outcomes
- ClinicalTrials.gov ID
- NCT05014477
- Acronym / sponsor ID
- LAAODE / CVC-003
- Keywords
- left atrial appendage occluder, device embolization, therapy strategy, risk factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Cardiovascular Center FrankfurtUniversity, hospital or other
- Collaborators
- 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, Liverpool Heart and Chest Hospital NHS Foundation Trust, Pradhum Ram, Emory University, USA, Copenhagen University Hospital, Rigshospitalet, 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, Vanderbilt University, 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, 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, Centre Hospitalier Universitaire de Liege, Clinton Health Access Initiative Inc., 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
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients experiencing device embolization after left atrial appendage occlusion | – | Procedure: Removal or leaving of LAA occludersDevice embolization following either surgical or interventional left atrial appendage occlusion |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after interventional or surgical left atrial appendage occlusion with device embolization
Key inclusion criteria (1 listed)
- Patients after interventional or surgical left atrial appendage occlusion with device embolization
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Removal or leaving of LAA occludersAfter 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. | Procedure or surgery | Patients experiencing device embolization after left atrial appendage occlusion |
Primary outcome
Procedural mortality
Time frame: In-hospital stay, assessed up to 30 days
all-cause mortality during the index procedure, any procedure-related death within 30days or during in-hospital stay for the index procedure (if>30days)
Need for cardiac surgery
Time frame: In-hospital stay, assessed up to 30 days
Catheter-based retrieval of LAA Occluder
Time frame: up to 5 years (after device implantation)
peri-procedural device removal
2 secondary outcomes
Further complications
Time frame: up to 5 years (after device implantation)
Risk factors
Time frame: up to 30 days (after device implantation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Derived from this study: PubMed 38448258Eppinger S, Piayda K, Galea R, Sandri M, Maarse M, Guner A, Karabay CY, Pershad A, Ding WY, Aminian A, Akin I, Davtyan KV, Chugunov IA, Marijon E, Rosseel L, Schmidt TR, Amabile N, Korsholm K, Lund J, Guerios E, Amat-Santos IJ, Boccuzzi G, Ellis CR, Sabbag A, Ebelt H, Clapp B, Assa HV, Levi A, Ledwoch J, Lehmann S, Lee OH, Mark G, Schell W, Della Rocca DG, Natale A, de Backer O, Kefer J, Esteban PP, Abelson M, Ram P, Moceri P, Galache Osuna JG, Alvarez XM, Cruz-Gonzalez I, de Potter T, Ghassan M, Osadchiy A, Chen W, Goyal SK, Giannini F, Rivero-Ayerza M, Afzal S, Jung C, Skurk C, Langel M, Spence M, Merkulov E, Lempereur M, Shin SY, Mesnier J, McKinney HL, Schuler BT, Armero S, Gheorghe L, Ancona MBM, Santos L, Mansourati J, Nombela-Franco L, Nappi F, Kuhne M, Gaspardone A, van der Pals J, Montorfano M, Fernandez-Armenta J, Harvey JE, Rodes-Cabau J, Klein N, Sabir SA, Kim JS, Cook S, Kornowski R, Saraste A, Nielsen-Kudsk JE, Gupta D, Boersma L, Raber L, Sievert K, Sievert H, Bertog S. Embolization of percutaneous left atrial appendage closure devices: Timing, management and clinical outcomes. Cardiovasc Revasc Med. 2024 Jul;64:7-14. doi: 10.1016/j.carrev.2024.02.014. Epub 2024 Feb 28.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Eppinger principal investigator
CardioVascular Center (CVC) Frankfurt, Seckbacher Landstraße 65, 60389 Frankfurt am Main, Hesse, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Atrial Appendage Occluder and Device Embolisation, run by Cardiovascular Center Frankfurt at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural mortality (time frame: In-hospital stay, assessed up to 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05014477, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022; AzTrials last refreshed its copy on 3 Nov 2026.