EP Device Registry

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 Overview

• Status: Completed
• Conditions: Cardiac Rhythm Disorder
• Intervention / Treatment: Other: Standard of Care

• Study Type: Observational
• Enrollment (Actual): 5003

Contacts and Locations

Study Locations

• Austria
  • Lower Austria
    • Wiener Neustadt, Lower Austria, Austria, 2700
      • KH Wiener Neustadt
  • UPR AUS
    • Linz, UPR AUS, Austria, 4020
      • A. ö. Krankenhaus der Elisabethinen Linz
• Czechia
  • Moravia-Silesia
    • Brno, Moravia-Silesia, Czechia, 65691
      • FN U sv. Anny v Brno
• France
  • Auvergne
    • Clermont-Ferrand, Auvergne, France, 92514
      • Pôle Santé République
  • Provence-Alpes-Azur
    • Ollioules, Provence-Alpes-Azur, France, 83190
      • Polyclinique des fleurs
  • Provence-Alpes-Côte d'Azur Region
    • Avignon, Provence-Alpes-Côte d'Azur Region, France, 84082
      • Clinique Rhône-Durance
• Germany
  • Dresden, Germany
    • Herzzentrum Dresden GmbH Universitätsklinik
  • Bavaria
    • München, Bavaria, Germany, 80636
      • Deutsches Herzzentrum München des Freistaates Bayern
  • North Rhine-Westphalia
    • Cologne, North Rhine-Westphalia, Germany, 50937
      • Medizinische Einrichtungen der Universität zu Köln
• Hungary
  • Budapest
    • Budapest, Budapest, Hungary, 1122
      • Semmelweis University
• India
  • New Delhi, India
    • MAX Super Specialty Hospital
  • Trivandrum, India
    • Sree Chitra Tirunal Institute for Medical Sciences & tech.
  • Tmlnadu
    • Vellore, Tmlnadu, India
      • Christian Medical College & Hospital
• Italy
  • Pisa, Italy
    • Azienda Ospedaliero Universitaria Pisana
  • Lombard
    • Milan, Lombard, Italy, 20132
      • Ospedale San Raffaele
  • Rome
    • Roma, Rome, Italy, 00144
      • Policlinico Universitario A. Gemelli
  • Veneto
    • Mestre, Veneto, Italy, 30174
      • Ospedale dell'Angelo
• Netherlands
  • Provincie Friesland
    • Leeuwarden, Provincie Friesland, Netherlands, 8934AD
      • Medisch Centrum Leeuwarden
  • South Holland
    • The Hague, South Holland, Netherlands, 2545AA
      • Haga Ziekenhuis Locatie Leyenburg
  • Utrecht - Canada
    • Nieuwegein, Utrecht - Canada, Netherlands, 3435CM
      • St. Antonius ziekenhuis
• Portugal
  • Carnaxide, Portugal
    • Hospital de Santa Cruz
  • Lisbon, Portugal
    • Hospital Santa Marta
  • Porto District
    • Porto, Porto District, Portugal, 4202-451
      • Hospital de Sao Joao
• Spain
  • Andalusia
    • Huelva, Andalusia, Spain, 21005
      • Hospital General Juan Ramon Jimenez
  • Catalon
    • Barcelona, Catalon, Spain, 08036
      • Hospital Clinic de Barcelona
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Hospital de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Amber Miller, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2020
• Primary Completion (Actual): January 31, 2026
• Study Completion (Actual): January 31, 2026

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: ABT-CIP-10316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No