Registry for Abbott's electrophysiology devices
EP Device Registry
This study is collecting information on how safe and effective Abbott's heart devices are for patients with heart rhythm problems after they have had a procedure using these devices.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 7500 (estimated) |
| Sex | All |
| Sponsor | Abbott Medical Devices Industry-sponsored |
| Locations | 26 sites (Wiener Neustadt, Lower Austria and 25 other locations) |
| Trial ID | NCT04460209 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather ongoing, high-quality data regarding the safety, performance, and clinical benefits of Abbott's electrophysiology devices used in patients with cardiac rhythm disorders. Participants will have undergone an electrophysiology imaging or ablation procedure utilizing these devices and will be monitored according to standard care follow-up schedules. The study will not involve any experimental treatments, focusing instead on real-world outcomes associated with standard care practices.
Who should consider this trial
Good fit: Ideal candidates are patients who have undergone an electrophysiology imaging or ablation procedure using Abbott devices.
Not a fit: Patients currently participating in other clinical investigations that may affect the results of this registry will not benefit.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of the effectiveness and safety of Abbott's electrophysiology devices, leading to improved patient care.
How similar studies have performed: While this registry approach is common, the specific focus on Abbott's devices in a real-world setting may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject underwent an electrophysiology imaging (diagnostic procedure) and/or ablation procedure that used one or more Abbott devices covered by this Registry. * Subject is willing and able to comply with the site's standard of care follow-up schedule. Exclusion Criteria: * Subject is currently participating in another clinical investigation that may confound the results of this Registry.
Where this trial is running
Wiener Neustadt, Lower Austria and 25 other locations
- KH Wiener Neustadt — Wiener Neustadt, Lower Austria, Austria (Recruiting)
- A. ö. Krankenhaus der Elisabethinen Linz — Linz, Upr Aus, Austria (Recruiting)
- FN U sv. Anny v Brno — Brno, Moravia-Silesia, Czechia (Recruiting)
- Pole Sante Republique — Clermont-Ferrand, Auvergne, France (Recruiting)
- Polyclinique des Fleurs — Ollioules, Provence-Alpes-Azur, France (Recruiting)
- Clinique Rhône-Durance — Avignon, Provence, France (Completed)
- Deutsches Herzzentrum München des Freistaates Bayern — München, Bavaria, Germany (Recruiting)
- Medizinische Einrichtungen der Universität zu Köln — Köln, North Rhine-Westphalia, Germany (Recruiting)
- Herzzentrum Dresden GmbH Universitätsklinik — Dresde, Germany (Recruiting)
- Semmelweis University — Budapest, Hungary (Completed)
- Christian Medical College & Hospital — Vellore, Tmlnadu, India (Recruiting)
- Max Super Specialty Hospital — New Delhi, India (Recruiting)
- Sree Chitra Tirunal Institute for Medical Sciences & tech. — Trivandrum, India (Recruiting)
- Ospedale San Raffaele — Milano, Lombard, Italy (Recruiting)
- Policlinico Universitario A. Gemelli — Roma, Rome, Italy (Recruiting)
- Ospedale dell'Angelo — Mestre, Veneto, Italy (Recruiting)
- Azienda Ospedaliero Universitaria Pisana — Pisa, Italy (Recruiting)
- Medisch Centrum Leeuwarden — Leeuwarden, Friesland, Netherlands (Recruiting)
- St. Antonius Ziekenhuis — Nieuwegein, Utrecht - Canada, Netherlands (Completed)
- Haga Ziekenhuis Locatie Leyenburg — Den Haag, Zuid-Holland, Netherlands (Recruiting)
- Hospital de Santa Cruz — Carnaxide, Portugal (Recruiting)
- Hospital Santa Marta — Lisboa, Portugal (Recruiting)
- Hospital de São João — Porto, Portugal (Recruiting)
- Hospital General Juan Ramon Jimenez — Huelva, Andalusia, Spain (Recruiting)
- Hospital Clínic de Barcelona — Barcelona, Catalon, Spain (Recruiting)
- Hospital de Navarra — Pamplona, Navarre, Spain (Recruiting)
Study contacts
- Study coordinator: Maxime De Groof, MMD
- Email: maxime.degroof@abbott.com
- Phone: 27746859
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.