EP Device Registry

NCT ID: NCT04460209

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

7500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-12

Study Completion Date

2031-12-31

Brief Summary

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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

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Conditions

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Cardiac Rhythm Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Standard of Care

Standard of care mapping and/or ablation

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Sarver, PhD

Role: STUDY_DIRECTOR

Abbott

Locations

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KH Wiener Neustadt

Wiener Neustadt, Lower Austria, Austria

Site Status RECRUITING

A. ö. Krankenhaus der Elisabethinen Linz

Linz, UPR AUS, Austria

Site Status RECRUITING

FN U sv. Anny v Brno

Brno, Moravia-Silesia, Czechia

Site Status RECRUITING

Pole Sante Republique

Clermont-Ferrand, Auvergne, France

Site Status RECRUITING

Polyclinique des Fleurs

Ollioules, Provence-Alpes-Azur, France

Site Status RECRUITING

Clinique Rhône-Durance

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

Site Status COMPLETED

Deutsches Herzzentrum München des Freistaates Bayern

München, Bavaria, Germany

Site Status RECRUITING

Medizinische Einrichtungen der Universität zu Köln

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Herzzentrum Dresden GmbH Universitätsklinik

Dresden, , Germany

Site Status RECRUITING

Semmelweis University

Budapest, Budapest, Hungary

Site Status COMPLETED

Christian Medical College & Hospital

Vellore, Tmlnadu, India

Site Status RECRUITING

Max Super Specialty Hospital

New Delhi, , India

Site Status RECRUITING

Sree Chitra Tirunal Institute for Medical Sciences & tech.

Trivandrum, , India

Site Status RECRUITING

Ospedale San Raffaele

Milan, Lombard, Italy

Site Status RECRUITING

Policlinico Universitario A. Gemelli

Roma, Rome, Italy

Site Status RECRUITING

Ospedale dell'Angelo

Mestre, Veneto, Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Site Status RECRUITING

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, Netherlands

Site Status RECRUITING

Haga Ziekenhuis Locatie Leyenburg

The Hague, South Holland, Netherlands

Site Status RECRUITING

St. Antonius Ziekenhuis

Nieuwegein, Utrecht - Canada, Netherlands

Site Status COMPLETED

Hospital de São João

Porto, Porto District, Portugal

Site Status RECRUITING

Hospital de Santa Cruz

Carnaxide, , Portugal

Site Status RECRUITING

Hospital Santa Marta

Lisbon, , Portugal

Site Status RECRUITING

Hospital General Juan Ramon Jimenez

Huelva, Andalusia, Spain

Site Status RECRUITING

Hospital Clínic de Barcelona

Barcelona, Catalon, Spain

Site Status RECRUITING

Hospital de Navarra

Pamplona, Navarre, Spain

Site Status RECRUITING

Countries

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Austria Czechia France Germany Hungary India Italy Netherlands Portugal Spain

Central Contacts

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Maxime De Groof, MMD

Role: CONTACT

27746859 ext. 32

Elizabeth Komosa

Role: CONTACT

Facility Contacts

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Christina Mayr

Role: primary

Carina Gutenbrunner

Role: primary

Alice Vybiralova

Role: primary

Nicolas Caillot

Role: primary

Francine Moll

Role: primary

Sabine Brandhorst

Role: primary

Hans Guenther Balk

Role: primary

Anastasia Hankel

Role: primary

Rintu James

Role: primary

Chandini Nair

Role: primary

Vineeth Cp

Role: primary

Caterina Bisceglia

Role: primary

Gaetano Pinnacchio

Role: primary

Paolo China, MD

Role: primary

Raffaele De Lucia

Role: primary

Dirk Jan De Boer

Role: primary

Nadine De Roode

Role: primary

Liliana Meneses, Tech

Role: primary

Natacha Almeida

Role: primary

Mafalda Selas

Role: primary

Maria Teresa Moraleda

Role: primary

Marina Poza

Role: primary

Alicia Gainza Calleja, BN

Role: primary

+34848423320

Other Identifiers

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ABT-CIP-10316

Identifier Type: -

Identifier Source: org_study_id

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