EP Device Registry

Cardiac Rhythm Disorder Clinical Trial

Official title:

EP Device Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04460209
• Other study ID #: ABT-CIP-10316
• Status: Recruiting
• Start date: June 12, 2020
• Est. completion date: December 2031

Study information

• Verified date: June 2024
• Source: Abbott Medical Devices
• Contact: Maxime De Groof, MMD
• Phone: 27746859
• Email: maxime.degroof[@]abbott.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7500
• Est. completion date: December 2031
• Est. primary completion date: November 2030
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Rhythm Disorder

Intervention

Other:
• Standard of Care
Standard of care mapping and/or ablation

Locations

Country	Name	City	State
Austria	A. ö. Krankenhaus der Elisabethinen Linz	Linz	Upr Aus
Austria	KH Wiener Neustadt	Wiener Neustadt	Lower Austria
Czechia	FN U sv. Anny v Brno	Brno	Moravia-Silesia
France	Clinique Rhône-Durance	Avignon	Provence-Alpes-Côte d'Azur
France	Pole Sante Republique	Clermont-Ferrand	Auvergne
France	Polyclinique des Fleurs	Ollioules	Provence-Alpes-Azur
Germany	Herzzentrum Dresden GmbH Universitätsklinik	Dresde
Germany	Medizinische Einrichtungen der Universität zu Köln	Köln	North Rhine-Westphalia
Germany	Deutsches Herzzentrum München des Freistaates Bayern	München	Bavaria
Hungary	Semmelweis University	Budapest
India	Max Super Specialty Hospital	New Delhi
India	Sree Chitra Tirunal Institute for Medical Sciences & tech.	Trivandrum
India	Christian Medical College & Hospital	Vellore	Tmlnadu
Italy	Ospedale dell'Angelo	Mestre	Veneto
Italy	Ospedale San Raffaele	Milano	Lombard
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Italy	Policlinico Universitario A. Gemelli	Roma	Rome
Netherlands	Haga Ziekenhuis Locatie Leyenburg	Den Haag	Zuid-Holland
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden	Friesland
Netherlands	St. Antonius Ziekenhuis	Nieuwegein	Utrecht - Canada
Portugal	Hospital de Santa Cruz	Carnaxide
Portugal	Hospital Santa Marta	Lisboa
Portugal	Hospital de São João	Porto
Spain	Hospital Clínic de Barcelona	Barcelona	Catalon
Spain	Hospital General Juan Ramon Jimenez	Huelva	Andalusia
Spain	Hospital de Navarra	Pamplona	Navarre

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Austria,  Czechia,  France,  Germany,  Hungary,  India,  Italy,  Netherlands,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with a device- and/or procedure-related Serious Adverse Event	that occurred within 7-days of the procedure.	7-days
Primary	The proportion of procedures that achieved acute success.		Baseline