Postmarket Evaluation of the Phased Radio Frequency Ablation System (GOLD AF Registry)
1 other identifier
observational
1,071
14 countries
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2015
Longer than P75 for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 17, 2015
CompletedFirst Posted
Study publicly available on registry
May 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedResults Posted
Study results publicly available
May 1, 2020
CompletedFebruary 13, 2025
February 1, 2025
3.7 years
March 17, 2015
March 29, 2020
February 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Estimate Phased RFA (Radio Frequency Ablation) Mid-term Success Rate
Success rate will be estimated as time to first event: AF recurrence and/or left Atrial Flutter. Parameters of interest include: re-ablations, ECG/EGM (electrogram) recorded AF, electrical and pharmacological cardioversions.
Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
Secondary Outcomes (1)
Estimate Phased RFA Mid-term Safety
Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
Other Outcomes (12)
Acute Procedural Success Rate
Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
Procedural Efficiency - Procedure Duration, Laboratory Occupancy Duration and Fluoroscopy Time
Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
Peri-procedural Anticoagulation Therapy - Activated Clotting Time
Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
- +9 more other outcomes
Eligibility Criteria
Eligible are all patients with paroxysmal, persistent and long-standing persistent AF who fulfill all inclusion criteria.
You may qualify if:
- Patient with AF who is scheduled for Phased RFA procedure
- Patient signed patient informed consent or patient data release form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
CHU Angers
Angers, France
CHU de Bordeaux
Bordeaux, France
CMC Parly 2
Le Chesnay, 78150, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ralf Meyer
- Organization
- Medtronic GmbH
Study Officials
- PRINCIPAL INVESTIGATOR
Lucas Boersma, MD, Ph.D
St. Antonious
- PRINCIPAL INVESTIGATOR
Meleze Hocini, MD
Hôpital Cardiologique du Haut-Lévêque
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2015
First Posted
May 5, 2015
Study Start
March 1, 2015
Primary Completion
November 20, 2018
Study Completion
May 1, 2019
Last Updated
February 13, 2025
Results First Posted
May 1, 2020
Record last verified: 2025-02