EP Device Registry

NCT04460209 | Completed

• 1 other identifier: ABT-CIP-10316
• Study Type: observational
• Target: 5,003
• Locations: 10 countries
• Sites: 26

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.

Conditions

Cardiac Rhythm Disorder

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Standard of Care OTHER

Standard of care mapping and/or ablation

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Subject is currently participating in another clinical investigation that may confound the results of this Registry.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (26)

KH Wiener Neustadt

Wiener Neustadt, Lower Austria, 2700, Austria

Location

A. ö. Krankenhaus der Elisabethinen Linz

Linz, UPR AUS, 4020, Austria

Location

FN U sv. Anny v Brno

Brno, Moravia-Silesia, 65691, Czechia

Location

Pole Sante Republique

Clermont-Ferrand, Auvergne, 92514, France

Location

Polyclinique des Fleurs

Ollioules, Provence-Alpes-Azur, 83190, France

Location

Clinique Rhône-Durance

Avignon, Provence-Alpes-Côte d'Azur Region, 84082, France

Location

Deutsches Herzzentrum München des Freistaates Bayern

München, Bavaria, 80636, Germany

Location

Medizinische Einrichtungen der Universität zu Köln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Herzzentrum Dresden GmbH Universitätsklinik

Dresden, Germany

Location

Semmelweis University

Budapest, Budapest, 1122, Hungary

Location

Christian Medical College & Hospital

Vellore, Tmlnadu, India

Location

Max Super Specialty Hospital

New Delhi, India

Location

Sree Chitra Tirunal Institute for Medical Sciences & tech.

Trivandrum, India

Location

Ospedale San Raffaele

Milan, Lombard, 20132, Italy

Location

Policlinico Universitario A. Gemelli

Roma, Rome, 00144, Italy

Location

Ospedale dell'Angelo

Mestre, Veneto, 30174, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Location

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, 8934AD, Netherlands

Location

Haga Ziekenhuis Locatie Leyenburg

The Hague, South Holland, 2545AA, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Utrecht - Canada, 3435CM, Netherlands

Location

Hospital de São João

Porto, Porto District, 4202-451, Portugal

Location

Hospital de Santa Cruz

Carnaxide, Portugal

Location

Hospital Santa Marta

Lisbon, Portugal

Location

Hospital General Juan Ramon Jimenez

Huelva, Andalusia, 21005, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Catalon, 08036, Spain

Location

Hospital de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Amber Miller

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 7, 2020
• Study Start: June 12, 2020
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (3); CZ (1); DE (3); IT (4); AU (2); FR (3); HU (1); ES (3); PT (3); NL (3)