Cardiac Rhythm DisorderNCT04460209
EP Device Registry
An observational study of Cardiac Rhythm Disorder, run by Abbott Medical Devices at 26 sites in 10 countries.
Trial summary
This study will provide ongoing, high quality data on the safety, performance, and clinical benefits of Abbott's EP devices in a real-world setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Rhythm Disorder
- How many people
- 5,003 participants
- Where
- 26 sitesin 10 countries
- Study dates
- 12 Jun 2020to 31 Jan 2026
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Male and female subjects of all ages who underwent an electrophysiology (EP) imaging (diagnostic procedure) and/or ablation procedure that used at least one Abbott device covered by this Registry.
Who may be able to join
- 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.
Who cannot join
- Subject is currently participating in another clinical investigation that may confound the results of this Registry.
Trial locations and contacts
26 sites in 10 countries.
26 sites in 10 countries
Italy4 sites
Ospedale dell'Angelo
Mestre, Veneto, 30174
Ospedale San Raffaele
Milan, Lombard, 20132
Azienda Ospedaliero Universitaria Pisana
Pisa
Policlinico Universitario A. Gemelli
Roma, Rome, 00144
France3 sites
Clinique Rhône-Durance
Avignon, Provence, 84082
Pole Sante Republique
Clermont-Ferrand, Auvergne, 92514
Polyclinique des Fleurs
Ollioules, Provence-Alpes-Azur, 83190
Germany3 sites
Medizinische Einrichtungen der Universität zu Köln
Cologne, North Rhine-Westphalia, 50937
Herzzentrum Dresden GmbH Universitätsklinik
Dresden
Deutsches Herzzentrum München des Freistaates Bayern
München, Bavaria, 80636
India3 sites
Max Super Specialty Hospital
New Delhi
Sree Chitra Tirunal Institute for Medical Sciences & tech.
Trivandrum
Christian Medical College & Hospital
Vellore, Tmlnadu
Netherlands3 sites
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, 8934AD
St. Antonius Ziekenhuis
Nieuwegein, Utrecht - Canada, 3435CM
Haga Ziekenhuis Locatie Leyenburg
The Hague, South Holland, 2545AA
Portugal3 sites
Hospital de Santa Cruz
Carnaxide
Hospital Santa Marta
Lisbon
Hospital de São João
Porto, Porto District, 4202-451
Spain3 sites
Hospital Clínic de Barcelona
Barcelona, Catalon, 08036
Hospital General Juan Ramon Jimenez
Huelva, Andalusia, 21005
Hospital de Navarra
Pamplona, Navarre, 31008
Austria2 sites
A. ö. Krankenhaus der Elisabethinen Linz
Linz, UPR AUS, 4020
KH Wiener Neustadt
Wiener Neustadt, Lower Austria, 2700
About this study
This study will provide ongoing, high quality data on the safety, performance, and clinical benefits of Abbott's EP devices in a real-world setting.
- Conditions
- Cardiac Rhythm Disorder
- Being tested
- Standard of Care
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Standard of care mapping and/or ablation
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with a device- and/or procedure-related Serious Adverse Event
that occurred within 7-days of the procedure.
Measured: 7-days
The proportion of procedures that achieved acute success.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start12 Jun 2020
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Rhythm DisorderStudies 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
- Prospective
- Enrolment
- 5,003 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amber Miller, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460209
- Sponsor's protocol ID
- ABT-CIP-10316
- Status last verified
- Mar 2026
- First submitted
- 29 Jun 2020
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EP Device Registry
- ClinicalTrials.gov ID
- NCT04460209
- Acronym / sponsor ID
- ABT-CIP-10316
- Conditions
- Cardiac Rhythm Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,003 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 7 Jul 2020 (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.
This study will provide ongoing, high quality data on the safety, performance, and clinical benefits of Abbott's EP devices in a real-world setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Male and female subjects of all ages who underwent an electrophysiology (EP) imaging (diagnostic procedure) and/or ablation procedure that used at least one Abbott device covered by this Registry.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Subject is currently participating in another clinical investigation that may confound 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 |
|---|---|---|
| Standard of CareStandard of care mapping and/or ablation | Other | – |
Primary outcome
The proportion of patients with a device- and/or procedure-related Serious Adverse Event
Time frame: 7-days
that occurred within 7-days of the procedure.
The proportion of procedures that achieved acute success.
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Amber Miller study director
Abbott
26 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Rhythm Disorder, run by Abbott Medical Devices at 26 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 2 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: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Italy, France, Germany, India, Netherlands 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The proportion of patients with a device- and/or procedure-related Serious Adverse Event (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 12 Mar 2026.