Postmarket Evaluation of the Phased Radio Frequency Ablation System (GOLD AF Registry)

NCT ID: NCT02433613

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1071 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2019-05-31

Brief Summary

Prospective, multi-center, single-arm, non-interventional and open-label registry. The purpose of the registry is to document use of Phased Radio Frequency Ablation (RFA) (hereafter "Phased RFA") System in a real world patient population with atrial fibrillation (AF) and evaluate its performance.

Gold AF will enroll a minimum of 1,000 patients who undergo Phased RFA in approximately 38 sites in Western, Central Europe, Israel and South Korea.

Detailed Description

This registry will collect data prospectively on patients with paroxysmal, persistent and longstanding persistent atrial fibrillation (hereafter "AF") undergoing Phased RFA treatment. Phased RFA will be applied according to the 'Intended Use' in CE mark (European Conformity) release and product packaging.

The treatment will be performed according to routine hospital practice and no additional tests are required specific to the registry. This registry will serve as a tool to collect clinical data in order to expand the knowledge base of safety, effectiveness and functionality of the Medtronic Phased RFA System in a real world patient population.

The key measures collected for the patients will be inclusive of, but are not limited to, clinical data pertaining to AF and individual disease state(s) characterized by form of AF and underline diseases, Phased RFA procedure details including timing and catheters in use, procedure and system related adverse events, AF recurrence, re-ablations and left atrial flutter rate after the index Phased RFA procedure. Additionally, this study will provide further information in the evolving anticoagulation strategies (e.g. continuous versus bridging and vitamin K antagonist versus novel oral anticoagulants) in the setting of AF ablations. Patients will be followed minimum for 12 months and maximum for 14 months after the Phased RFA ablation procedure. The twelve month follow-up can be done by telephone if it is not standard of care in the hospital's practice. During the twelve month follow-up patients will be interviewed with a quality of life questionnaire and results will be compared to the quality of life questionaire completed before the procedure.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patient with AF who is scheduled for Phased RFA procedure
• Patient signed patient informed consent or patient data release form

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IHF GmbH - Institut für Herzinfarktforschung

OTHER

Sponsor Role: collaborator

Medtronic Cardiac Ablation Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lucas Boersma, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

St. Antonious

Meleze Hocini, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Cardiologique du Haut-Lévêque

Locations

CHU Angers

Angers, , France

CHU de Bordeaux

Bordeaux, , France

CMC Parly 2

Le Chesnay, , France

Centre Cardiologique du Nord

Saint-Denis, , France

Jo Ann Medical Center

Tbilisi, , Georgia

St. Johannes Hospital

Dortmund, , Germany

Evangelisches Krankenhaus

Düsseldorf, , Germany

Helios Klinikum Erfurt

Erfurt, , Germany

Herz- und Gefäßzentrum Oberallgäu-Kempten

Kempten, , Germany

Universitätsklinikum Münster

Münster, , Germany

St. Vincenz-Krankenhaus Paderborn

Paderborn, , Germany

General Hospital Alexandra

Athens, , Greece

Military Hospital

Budapest, , Hungary

University of Debrecen

Debrecen, , Hungary

The Barzilai Medical Center Ashkleon

Ashkelon, , Israel

Soroka University Medical Center

Beersheba, , Israel

Hadassah Medical Center

Jerusalem, , Israel

Kaplan Medical Center

Rehovot, , Israel

A.O. Papa Giovanni XXIII

Bergamo, , Italy

Az. Osped. Pugliese Ciaccio

Catanzaro, , Italy

Ospedale Mater Salutis

Legnago, , Italy

A.O. Osped. S.Gerardo

Monza, , Italy

A.O. San Camillo Forlanini

Rome, , Italy

Medisch Centrum Leeuwarden B.V.

Leeuwarden, , Netherlands

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

Samodzielny Publiczny Szpital Kliniczny Nr 4

Lublin, , Poland

Samodzielny Publiczny Szpital Kliniczny Nr 2

Szczecin, , Poland

Samodzielny Publiczny Centralny Szpital Kliniczny

Warsaw, , Poland

4 Wojskowy Szpital Kliniczny

Wroclaw, , Poland

Centro Hospitalar Lisboa Notre - Hospital de Santa Maria E.P.E.

Lisbon, , Portugal

Sejong General Hospital

Bucheon-si, , South Korea

Keimyung University Dongsan Hospital

Daegu, , South Korea

Yeungnam University Hospital

Daegu, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Asan Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Hospital Donostia

Donostia / San Sebastian, , Spain

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hirslanden Klinik St. Anna AG

Zurich, , Switzerland

Eastbourne District General Hospital

Eastbourne, , United Kingdom

Countries

France; Georgia; Germany; Greece; Hungary; Israel; Italy; Netherlands; Poland; Portugal; South Korea; Spain; Switzerland; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

GOLD AF

Identifier Type: -

Identifier Source: org_study_id