EP Device Registry

Recruiting

• Conditions: Cardiac Rhythm Disorder

• Registration Number: NCT04460209
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-12
• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2030-11
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of procedures that achieved acute success.	Baseline
The proportion of patients with a device- and/or procedure-related Serious Adverse Event	7-days	that occurred within 7-days of the procedure.

Trial Locations

Locations (26)

KH Wiener Neustadt; 🇦🇹 Wiener Neustadt, Lower Austria, Austria

Polyclinique des Fleurs; 🇫🇷 Ollioules, Provence-Alpes-Azur, France

A. ö. Krankenhaus der Elisabethinen Linz; 🇦🇹 Linz, Upr Aus, Austria

Semmelweis University; 🇭🇺 Budapest, Hungary

FN U sv. Anny v Brno; 🇨🇿 Brno, Moravia-Silesia, Czechia

Pole Sante Republique; 🇫🇷 Clermont-Ferrand, Auvergne, France

Clinique Rhône-Durance; 🇫🇷 Avignon, Provence, France

Deutsches Herzzentrum München des Freistaates Bayern; 🇩🇪 München, Bavaria, Germany

Medizinische Einrichtungen der Universität zu Köln; 🇩🇪 Köln, North Rhine-Westphalia, Germany

Herzzentrum Dresden GmbH Universitätsklinik; 🇩🇪 Dresde, Germany

Christian Medical College & Hospital; 🇮🇳 Vellore, Tmlnadu, India

Max Super Specialty Hospital; 🇮🇳 New Delhi, India

Sree Chitra Tirunal Institute for Medical Sciences & tech.; 🇮🇳 Trivandrum, India

Ospedale San Raffaele; 🇮🇹 Milano, Lombard, Italy

Policlinico Universitario A. Gemelli; 🇮🇹 Roma, Rome, Italy

Ospedale dell'Angelo; 🇮🇹 Mestre, Veneto, Italy

Azienda Ospedaliero Universitaria Pisana; 🇮🇹 Pisa, Italy

Medisch Centrum Leeuwarden; 🇳🇱 Leeuwarden, Friesland, Netherlands

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Utrecht - Canada, Netherlands

Haga Ziekenhuis Locatie Leyenburg; 🇳🇱 Den Haag, Zuid-Holland, Netherlands

Hospital de Santa Cruz; 🇵🇹 Carnaxide, Portugal

Hospital Santa Marta; 🇵🇹 Lisboa, Portugal

Hospital de São João; 🇵🇹 Porto, Portugal

Hospital General Juan Ramon Jimenez; 🇪🇸 Huelva, Andalusia, Spain

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Catalon, Spain

Hospital de Navarra; 🇪🇸 Pamplona, Navarre, Spain