Heart DiseasesSH-RegistryNCT06590467
Abbott Structural Heart Device Registry
An observational study of Heart Diseases and ASD - Atrial Septal Defect, run by Abbott Medical Devices at 36 sites in 10 countries.
Trial summary
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting. The Registry primarily involves gathering data from routine hospital practices and standard-of-care (SOC) procedures administered to patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Diseases, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect
- What is being tested?
- Amplatzer™ Occlusion Devices and Epic™ Surgical Tissue Heart Valve devices
- Type of treatment
- Medical device
- How many people
- 2,500 participants
- Where
- 36 sitesin 10 countries
- Study dates
- 21 Aug 2024to Nov 2039
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This Registry is open to enroll subjects of all genders and ages from the general population who undergo a procedure that use at least one Abbott SH device included in this Registry (including unsuccessful implants). Subjects must meet all eligibility criteria and provide written informed consent prior to sites conducting any investigation-specific procedures not considered standard of care. Patients will be screened for eligibility and willingness to participate prior to the procedure or, if enrolled retrospectively, within the timeframe specified in the device-specific appendices of the protocol (Amplatzer cohort: consent within 7days of procedure // Cardiac Surgery (The ENDURE Study) cohort: consent within 6 months (183 days) of the implant procedure)
Who may be able to join
- Subject is expected to undergo an implant attempt using one or more Abbott Structural Heart devices covered in this Registry or has previously undergone an implant attempt within the timeframes specified in the device-specific appendices.
- Subject is willing and able to comply with the site's standard of care follow-up schedule.
- Subject is willing to provide appropriate informed consent for Registry participation. For deceased subjects enrolled retrospectively, local regulations and EC/IRB recommendations regarding consent and the protection of personal data must be followed.
Who cannot join
- 1. Subject is participating in another clinical study that would affect the results of this Registry.
Trial locations and contacts
36 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
36 sites in 10 countries
United States13 sites, 13 recruiting
- Not yet recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Edward Soltesz, MD
Edward Soltesz, MD
- Not yet recruiting
Mayo Clinic Health System - Eau Claire Hospital, Inc.
Eau Claire, Wisconsin, 54702
Robert Wiechmann, MD
Robert Wiechmann, MD
- Not yet recruiting
USC University Hospital
Los Angeles, California, 90033
Craig Baker, MD
Craig Baker, MD
- Not yet recruiting
Baptist Hospital of Miami
Miami, Florida, 33176
Tom Nguyen, MD
Tom Nguyen, MD
- Recruiting
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
Leonard Lee, MD
Leonard Lee, MD
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Ismail El-Hamamsy, MD
Ismail El-Hamamsy, MD
- Not yet recruiting
New York Presbyterian Hospital/Cornell University
New York, New York, 10065
Joshua Goldberg, MD
Joshua Goldberg, MD
- Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Clinton Kemp, MD
Clinton Kemp, MD
- Not yet recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Chase Brown, MD
Chase Brown, MD
- Recruiting
UPMC
Pittsburgh, Pennsylvania, 15213
Derek Serna Gallegos, MD
Derek Serna Gallegos, MD
- Not yet recruiting
University of Washington Medical Center
Seattle, Washington, 98195
Scott DeRoo, MD
Scott DeRoo, MD
- Not yet recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Tsuyoshi Kaneko, MD
Tsuyoshi Kaneko, MD
- Not yet recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Thomas MacGillivray, MD
Thomas MacGillivray, MD
Germany6 sites, 6 recruiting
- Recruiting
Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG
Bad Rothenfelde, 32545
Nicolas Doll, Prof.
Nicolas Doll, Prof.
- Recruiting
Deutsches Herzzentrum der Charité
Berlin, State of Berlin, 13353
Peter Kramer, Dr. med.
Peter Kramer, Dr. med.
- Recruiting
Städt. Klinikum Braunschweig gGmbH
Braunschweig, L Saxon, 38126
Ingo Breitenbach, Dr. med.
Ingo Breitenbach, Dr. med.
- Recruiting
Klinikum Links der Weser
Bremen, Free Hanseatic City of Bremen, 28277
Jens Garbade, Prof. Dr. med.
Jens Garbade, Prof. Dr. med.
- Recruiting
Universitatsklinikum Jena
Jena, Germany, 07747
Torsten Doenst, Prof. Dr.
Torsten Doenst, Prof. Dr.
- Recruiting
Deutsches Herzzentrum München des Freistaates Bayern
München, Bavaria, 80636
Stanimir Georgiev, Dr. med.
Stanimir Georgiev, Dr. med.
Italy4 sites, 4 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56126
Andrea Colli, Prof.
Andrea Colli, Prof.
- Recruiting
IRCCS Policlinico San Donato - Cardio
San Donato Milanese, Lombardy, 20097
Angelo Fabio D'Aiello, MD
Angelo Fabio D'Aiello, MD
- Recruiting
Policlinico San Donato
San Donato Milanese, Lombardy, 20097
Francesco Bedogni, MD
Francesco Bedogni, MD
- Recruiting
A.O.U. Citta della Salute e della Scienza di Torino
Turin, Piedmont, 10126
Giuseppe Annoni
Giuseppe Annoni
Spain4 sites, 4 recruiting
- Recruiting
Hospital Infantil Sant Joan De Deu
Esplugues de Llobregat, Catalonia, 08950
Juan Manuel Carretero Bellon
Juan Manuel Carretero Bellon
- Recruiting
Hospital Universitario de la Paz - Pediatrico
Madrid, 28046
Federico Gutierrez Larraya, Dr.
Federico Gutierrez Larraya, Dr.
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Jacobo Silva Guisasola
Jacobo Silva Guisasola
- Recruiting
Hospital Virgen de Rocio
Seville, Spain, 41013
Jose Miguel Borrego Dominguez, Dr
Jose Miguel Borrego Dominguez, Dr
France3 sites, 3 recruiting
- Recruiting
Hôpital Marie-Lannelongue
Le Plessis-Robinson, 92350
Sebastien Hascoet, Dr.
Sebastien Hascoet, Dr.
- Recruiting
Hopital Haut Leveque
Pessac, 33604
Zakaria Jalal, Dr.
Zakaria Jalal, Dr.
- Recruiting
CHU Rennes, Pontchaillou
Rennes, Brittan, 35033
Amedeo Anselmi
Amedeo Anselmi
United Kingdom2 sites, 2 recruiting
- Recruiting
Royal Brompton Hospital
London, UK, SW3 6NP
Alain Fraisse, Dr.
Alain Fraisse, Dr.
- Recruiting
St. Thomas Hospital
London, SE1 7EH
Matthew Jones, Dr.
Matthew Jones, Dr.
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense, Southern Denmark, 5000
Lars Peter Riber, Prof.
Lars Peter Riber, Prof.
Estonia1 site, 1 recruiting
- Recruiting
Tartu University Hospital
Tartu, Tartu, 50406
Arno Ruusalepp, Prof.
Arno Ruusalepp, Prof.
Ireland1 site, 1 recruiting
- Recruiting
Children's Health Ireland (CHI)
Crumlin, Dublin, D12N512
Damien Kenny, Prof.
Damien Kenny, Prof.
Poland1 site, 1 recruiting
- Recruiting
Slaskie Centrum Chorob Serca
Zabrze, Silesian Voivodeship, 41-800
Roland Fiszer, Prof.
Roland Fiszer, Prof.
About this study
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting. The Registry primarily involves gathering data from routine hospital practices and standard-of-care (SOC) procedures administered to patients. All devices used in these procedures must be commercially available to the participating site. A list of specific devices covered by the Registry are available upon request from the Sponsor. Data generated by the Registry will be used to meet regulatory requirements, such as the European Union Medical Device Regulations 2017/745, that require active post-market clinical follow-up (PMCF) for all commercially available devices.
Read the detailed description
The Abbott SH Device Registry is designed to confirm the safety and performance of commercially available Abbott SH devices as they are used in routine hospital practice or SOC procedures. Patients will be screened for eligibility and willingness to participate prior to the procedure or, if enrolled retrospectively, within the following timeframes:
- Amplatzer portion: within 7 days post-procedure
- Cardiac Surgery portion (The ENDURE Study): within 6 months post-procedure.
All patients who provide informed consent and undergo an implant attempt with an applicable Abbott SH device are eligible to participate in the Registry. The Registry anticipates that approximately 500 subjects per year will be enrolled. The projected enrollment period is at least 5 years.
The Registry will be conducted at approximately 25 sites worldwide. Additional sites may be approached for participation in the Registry as needed.
Follow-up visits should align with the site's routine SOC visits for the associated procedure. Data collection will occur post-screening and consent and at post-procedure SOC follow-up visit(s). Where applicable, follow-up visits may occur over the telephone, virtually, or in-office, following SOC practice.
The follow-up duration will depend on the Abbott device(s) used during the procedure. Certain devices will utilize data collection at discharge (or 7 days post procedure, whichever comes first), short-term (1 - 3 months as applicable), a mid-term (6 months), and long-term follow-up (12 months) visits to support clinical safety and performance data requirements. Alternatively, some devices will have follow-up visits extending up to 10 years to monitor subjects throughout the devices' lifetime.
A surgical valve-specific "Line Extension Sub-Study" is included in the protocol to collect data at European sites with the intention of applying for approval in the US for 2 specific surgical aortic valve sizes (Epic Max 27mm, and the Epic Plus Supra 29mm).
- Conditions
- Heart Diseases, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PFO - Patent Foramen Ovale, PIVSD - Post Infarct Muscular Ventricular Septal Defect, Valvular Heart Disease
- Being tested
- Amplatzer™ Occlusion Devices, Epic™ Surgical Tissue Heart Valve devices
- Keywords
- Amplatzer, Amplatzer Septal Occluder, Amplatzer Multi-fenestrated (Cribriform) Occluder, Amplatzer Duct Occluder, Amplatzer Piccolo Occluder, Amplatzer Muscular VSD Occluder, Amplatzer Post-Infarct VSD Occluder, Amplatzer Talisman, Amplatzer TorqVue Delivery System, Amplatzer Sizing Balloon, Amplatzer Guidewire, Amplatzer Occluder devices, Surgical Valves, Epic Plus Aortic Valve, Epic Plus Mitral Valve, Epic Plus Supra Aortic Valve, Epic Max Aortic Valve, Bioprosthetic heart valve, Surgical tissue heart valve, Amplatzer Piccolo Delivery System
- Medical subject headings
- Heart Diseases, Heart Septal Defects, Atrial, Foramen Ovale, Patent, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amplatzer™ Occlusion DevicesDevice
Also called Amplatzer Septal Occluder, Amplatzer Multi-fenestrated (Cribriform) Occluder, Amplatzer Duct Occluder, Amplatzer Piccolo Occluder
The Amplatzer™ Occluders are devices intended for the occlusion of multiple septal heart defects.
Epic™ Surgical Tissue Heart Valve devicesDevice
Also called EMAX, E200, ESP200, Sizer Set Model E2000
The Epic™ valves are indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic/mitral heart valve. It may also be used as a replacement for a previously implanted aortic/mitral prosthetic heart valve.
| Study group | Role | What they receive |
|---|---|---|
| Amplatzer | * ASO: ≥50 cases/year
* ASD-MF: ≥50 cases/year
* ADO: ≥50 cases/year
* ADO II: ≥50 cases/year
* Piccolo: ≥50 cases/year
* MuVSD: Up to 50 cases/year
* PI-VSD: Up to 50 cases/year
* Talisman/TDS: ≥100 cases/year
* TorqVue Delivery Systems Group 1 (ATV/ITV/EITV/TV2): 250 cases/year across different occluders
* TorqVue Delivery Systems Group 2 (TVLP/TVLPC): 100 cases/year across different occluders
* Piccolo Delivery System (PDS): 50 cases total
* SB II:100 PFO cases/year \& 100 ASD cases/year
* GW: 200 cases/year Receives: Device: Amplatzer™ Occlusion Devices | |
| Cardiac Surgery (The ENDURE Study) | Approximately 1,800 subjects implanted with at least one applicable Abbott surgical tissue heart valve (THV) will be enrolled and followed for 10 years. The minimum required sample sizes for each THV model are listed below. Approximately N=100 Epic Max enrollments will occur in the United States. A combined total of approximately N=1000 subjects will be enrolled globally across the Epic Elite (aortic and mitral) and Epic Supra G3 models.
* Approximately 225 subjects receiving Epic Plus mitral valves
* Approximately 225 subjects receiving Epic Elite mitral valves
* Approximately 150 subjects receiving Epic Plus aortic valves
* Approximately 170 subjects receiving Epic Plus Supra aortic valves
* Approximately 170 subjects receiving Epic Supra G3 aortic valves
* Approximately 285 subjects receiving Epic Max aortic valves
* Approximately 285 subjects receiving Epic Elite aortic valves Receives: Device: Epic™ Surgical Tissue Heart Valve devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
The primary safety endpoint will be the proportion of subjects with device- and/or procedure-related serious adverse events (SAEs) occurring within 7 days of the procedure.
Measured: 7 days
Primary Effectiveness Endpoint
The primary effectiveness endpoint will be the proportion of procedures that achieved technical success, defined as completion of the procedure with an applicable Abbott SH device implanted
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start21 Aug 2024
- Primary completionDec 2029 (estimated)
- Study completionNov 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary Seale, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590467
- Sponsor's protocol ID
- ABT-CIP-10415
- Acronym
- SH-Registry
- Status last verified
- Apr 2026
- First submitted
- 2 Sep 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abbott Structural Heart Device Registry
- ClinicalTrials.gov ID
- NCT06590467
- Acronym / sponsor ID
- SH-Registry / ABT-CIP-10415
- Conditions
- Heart Diseases, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PFO - Patent Foramen Ovale, PIVSD - Post Infarct Muscular Ventricular Septal Defect, Valvular Heart Disease
- Keywords
- Amplatzer, Amplatzer Septal Occluder, Amplatzer Multi-fenestrated (Cribriform) Occluder, Amplatzer Duct Occluder, Amplatzer Piccolo Occluder, Amplatzer Muscular VSD Occluder, Amplatzer Post-Infarct VSD Occluder, Amplatzer Talisman
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Nov 2039 (estimated)
- First posted
- 19 Sep 2024 (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 Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting. The Registry primarily involves gathering data from routine hospital practices and standard-of-care (SOC) procedures administered to patients. All devices used in these procedures must be commercially available to the participating site. A list of specific devices covered by the Registry are available upon request from the Sponsor. Data generated by the Registry will be used to meet regulatory requirements, such as the European Union Medical Device Regulations 2017/745, that require active post-market clinical follow-up (PMCF) for all commercially available devices.
Detailed description
The Abbott SH Device Registry is designed to confirm the safety and performance of commercially available Abbott SH devices as they are used in routine hospital practice or SOC procedures. Patients will be screened for eligibility and willingness to participate prior to the procedure or, if enrolled retrospectively, within the following timeframes:
- Amplatzer portion: within 7 days post-procedure
- Cardiac Surgery portion (The ENDURE Study): within 6 months post-procedure.
All patients who provide informed consent and undergo an implant attempt with an applicable Abbott SH device are eligible to participate in the Registry. The Registry anticipates that approximately 500 subjects per year will be enrolled. The projected enrollment period is at least 5 years.
The Registry will be conducted at approximately 25 sites worldwide. Additional sites may be approached for participation in the Registry as needed.
Follow-up visits should align with the site's routine SOC visits for the associated procedure. Data collection will occur post-screening and consent and at post-procedure SOC follow-up visit(s). Where applicable, follow-up visits may occur over the telephone, virtually, or in-office, following SOC practice.
The follow-up duration will depend on the Abbott device(s) used during the procedure. Certain devices will utilize data collection at discharge (or 7 days post procedure, whichever comes first), short-term (1 - 3 months as applicable), a mid-term (6 months), and long-term follow-up (12 months) visits to support clinical safety and performance data requirements. Alternatively, some devices will have follow-up visits extending up to 10 years to monitor subjects throughout the devices' lifetime.
A surgical valve-specific "Line Extension Sub-Study" is included in the protocol to collect data at European sites with the intention of applying for approval in the US for 2 specific surgical aortic valve sizes (Epic Max 27mm, and the Epic Plus Supra 29mm).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amplatzer | – | Device: Amplatzer™ Occlusion Devices* ASO: ≥50 cases/year * ASD-MF: ≥50 cases/year * ADO: ≥50 cases/year * ADO II: ≥50 cases/year * Piccolo: ≥50 cases/year * MuVSD: Up to 50 cases/year * PI-VSD: Up to 50 cases/year * Talisman/TDS: ≥100 cases/year * TorqVue Delivery Systems Group 1 (ATV/ITV/EITV/TV2): 250 cases/year across different occluders * TorqVue Delivery Systems Group 2 (TVLP/TVLPC): 100 cases/year across different occluders * Piccolo Delivery System (PDS): 50 cases total * SB II:100 PFO cases/year \& 100 ASD cases/year * GW: 200 cases/year |
| Cardiac Surgery (The ENDURE Study) | – | Device: Epic™ Surgical Tissue Heart Valve devicesApproximately 1,800 subjects implanted with at least one applicable Abbott surgical tissue heart valve (THV) will be enrolled and followed for 10 years. The minimum required sample sizes for each THV model are listed below. Approximately N=100 Epic Max enrollments will occur in the United States. A combined total of approximately N=1000 subjects will be enrolled globally across the Epic Elite (aortic and mitral) and Epic Supra G3 models. * Approximately 225 subjects receiving Epic Plus mitral valves * Approximately 225 subjects receiving Epic Elite mitral valves * Approximately 150 subjects receiving Epic Plus aortic valves * Approximately 170 subjects receiving Epic Plus Supra aortic valves * Approximately 170 subjects receiving Epic Supra G3 aortic valves * Approximately 285 subjects receiving Epic Max aortic valves * Approximately 285 subjects receiving Epic Elite aortic valves |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This Registry is open to enroll subjects of all genders and ages from the general population who undergo a procedure that use at least one Abbott SH device included in this Registry (including unsuccessful implants). Subjects must meet all eligibility criteria and provide written informed consent prior to sites conducting any investigation-specific procedures not considered standard of care. Patients will be screened for eligibility and willingness to participate prior to the procedure or, if enrolled retrospectively, within the timeframe specified in the device-specific appendices of the protocol (Amplatzer cohort: consent within 7days of procedure // Cardiac Surgery (The ENDURE Study) cohort: consent within 6 months (183 days) of the implant procedure)
Key inclusion criteria (3 listed)
- Subject is expected to undergo an implant attempt using one or more Abbott Structural Heart devices covered in this Registry or has previously undergone an implant attempt within the timeframes specified in the device-specific appendices.
- Subject is willing and able to comply with the site's standard of care follow-up schedule.
- Subject is willing to provide appropriate informed consent for Registry participation. For deceased subjects enrolled retrospectively, local regulations and EC/IRB recommendations regarding consent and the protection of personal data must be followed.
Key exclusion criteria (1 listed)
- 1. Subject is participating in another clinical study that would affect the results of this Registry.
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 |
|---|---|---|
| Amplatzer™ Occlusion DevicesAlso: Amplatzer Septal Occluder, Amplatzer Multi-fenestrated (Cribriform) Occluder, Amplatzer Duct Occluder, Amplatzer Piccolo OccluderThe Amplatzer™ Occluders are devices intended for the occlusion of multiple septal heart defects. | Device | Amplatzer |
| Epic™ Surgical Tissue Heart Valve devicesAlso: EMAX, E200, ESP200, Sizer Set Model E2000The Epic™ valves are indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic/mitral heart valve. It may also be used as a replacement for a previously implanted aortic/mitral prosthetic heart valve. | Device | Cardiac Surgery (The ENDURE Study) |
Primary outcome
Primary Safety Endpoint
Time frame: 7 days
The primary safety endpoint will be the proportion of subjects with device- and/or procedure-related serious adverse events (SAEs) occurring within 7 days of the procedure.
Primary Effectiveness Endpoint
Time frame: Baseline
The primary effectiveness endpoint will be the proportion of procedures that achieved technical success, defined as completion of the procedure with an applicable Abbott SH device implanted
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
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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.
Mary Seale study director
Abbott
36 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases and ASD - Atrial Septal Defect, run by Abbott Medical Devices at 36 sites in 10 countries.
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 3 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: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Germany, Italy, Spain, France and 5 more countries. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laetitia Beullens (+32 277 46 937, laetitia.beullens@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2026.