Clinical trial NCT04460209: EP Device Registry
Official title: EP Device Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Rhythm Disorder
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2020-07-07
Enrollment: 7500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.


Eligibility 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.

Primary outcomes:
measure: The proportion of patients with a device- and/or procedure-related Serious Adverse Event
timeFrame: 7-days
measure: The proportion of procedures that achieved acute success.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Wiener Neustadt
country: Austria
facility: KH Wiener Neustadt
state: Lower Austria
city: Linz
country: Austria
facility: A. ö. Krankenhaus der Elisabethinen Linz
state: Upr Aus
city: Brno
country: Czechia
facility: FN U sv. Anny v Brno
state: Moravia-Silesia
city: Clermont-Ferrand
country: France
facility: Pole Sante Republique
state: Auvergne
city: Ollioules
country: France
facility: Polyclinique des Fleurs
state: Provence-Alpes-Azur
city: Avignon
country: France
facility: Clinique Rhône-Durance
state: Provence
city: München
country: Germany
facility: Deutsches Herzzentrum München des Freistaates Bayern
state: Bavaria
city: Köln
country: Germany
facility: Medizinische Einrichtungen der Universität zu Köln
state: North Rhine-Westphalia
city: Dresde
country: Germany
facility: Herzzentrum Dresden GmbH Universitätsklinik
city: Budapest
country: Hungary
facility: Semmelweis University
city: Vellore
country: India
facility: Christian Medical College & Hospital
state: Tmlnadu
city: New Delhi
country: India
facility: Max Super Specialty Hospital
city: Trivandrum
country: India
facility: Sree Chitra Tirunal Institute for Medical Sciences & tech.
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Lombard
city: Roma
country: Italy
facility: Policlinico Universitario A. Gemelli
state: Rome
city: Mestre
country: Italy
facility: Ospedale dell'Angelo
state: Veneto
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
state: Friesland
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
state: Utrecht - Canada
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis Locatie Leyenburg
state: Zuid-Holland
city: Carnaxide
country: Portugal
facility: Hospital de Santa Cruz
city: Lisboa
country: Portugal
facility: Hospital Santa Marta
city: Porto
country: Portugal
facility: Hospital de São João
city: Huelva
country: Spain
facility: Hospital General Juan Ramon Jimenez
state: Andalusia
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
state: Catalon
city: Pamplona
country: Spain
facility: Hospital de Navarra
state: Navarre
Study officials:
affiliation: Abbott
name: Anne Sarver, PhD
role: STUDY_DIRECTOR
References: