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

NCT02433613 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1071

Last updated 2025-02-13

Study results available
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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.

Conditions

Sponsors & Collaborators

  • IHF GmbH - Institut für Herzinfarktforschung

    collaborator OTHER

  • Medtronic Cardiac Ablation Solutions

    lead INDUSTRY

Principal Investigators

  • Lucas Boersma, MD, Ph.D · St. Antonious

  • Meleze Hocini, MD · Hôpital Cardiologique du Haut-Lévêque

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-11-20
Completion
2019-05-31

Countries

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

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02433613 on ClinicalTrials.gov