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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation

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.

• Study Type: Observational
• Enrollment (Actual): 1071

Contacts and Locations

Study Locations

• France
  • Angers, France
    • CHU Angers
  • Bordeaux, France
    • CHU de Bordeaux
  • Le Chesnay, France, 78150
    • CMC Parly 2
  • Saint-Denis, France
    • Centre Cardiologique du Nord
• Georgia
  • Tbilisi, Georgia
    • Jo Ann Medical Center
• Germany
  • Dortmund, Germany
    • St. Johannes Hospital
  • Düsseldorf, Germany
    • Evangelisches Krankenhaus
  • Erfurt, Germany
    • Helios Klinikum Erfurt
  • Kempten, Germany
    • Herz- und Gefäßzentrum Oberallgäu-Kempten
  • Münster, Germany
    • Universitätsklinikum Münster
  • Paderborn, Germany
    • St. Vincenz-Krankenhaus Paderborn
• Greece
  • Athens, Greece
    • General Hospital Alexandra
• Hungary
  • Budapest, Hungary
    • Military Hospital
  • Debrecen, Hungary
    • University of Debrecen
• Israel
  • Ashkelon, Israel
    • The Barzilai Medical Center Ashkleon
  • Beer-Sheva, Israel
    • Soroka university medical center
  • Jerusalem, Israel
    • Hadassah Medical Center
  • Rehovot, Israel
    • Kaplan Medical Center
• Italy
  • Bergamo, Italy
    • A.O. Papa Giovanni XXIII
  • Catanzaro, Italy
    • Az. Osped. Pugliese Ciaccio
  • Legnago, Italy
    • Ospedale Mater Salutis
  • Monza, Italy
    • A.O. Osped. S.Gerardo
  • Rome, Italy
    • A.O. San Camillo Forlanini
• Korea, Republic of
  • Bucheon-si, Korea, Republic of
    • Sejong General Hospital
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Hospital
  • Daegu, Korea, Republic of
    • Yeungnam University Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
• Netherlands
  • Leeuwarden, Netherlands
    • Medisch Centrum Leeuwarden B.V.
  • Nieuwegein, Netherlands
    • St. Antonius Ziekenhuis
• Poland
  • Lublin, Poland
    • Samodzielny Publiczny Szpital Kliniczny nr 4
  • Szczecin, Poland
    • Samodzielny Publiczny Szpital Kliniczny Nr 2
  • Warszawa, Poland
    • Samodzielny Publiczny Centralny Szpital Kliniczny
  • Wroclaw, Poland
    • 4 Wojskowy Szpital Kliniczny
• Portugal
  • Lisboa, Portugal
    • Centro Hospitalar Lisboa Notre - Hospital de Santa Maria E.P.E.
• Spain
  • Donostia, Spain
    • Hospital Donostia
  • Madrid, Spain
    • Hospital General Universitario Gregorio Marañón
  • Madrid, Spain
    • Hospital Universitario 12 de Octubre
• Switzerland
  • Zürich, Switzerland
    • Hirslanden Klinik St. Anna AG
• United Kingdom
  • Eastbourne, United Kingdom
    • Eastbourne District General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Eligible are all patients with paroxysmal, persistent and long-standing persistent AF who fulfill all inclusion criteria.

Description

Inclusion criteria:

• Patient with AF who is scheduled for Phased RFA procedure
• Patient signed patient informed consent or patient data release form
• Age ≥18 years old To avoid enrollment bias in this cohort of patient and reflect "real world" clinical practice for Phased RFA no exclusion criteria will be defined.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate Phased RFA Mid-term Safety	Estimate major procedure/system related complications of Phased RFA	Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Procedural Success Rate	Procedure considered successful if all PVs (pulmonary veins) were isolated (entrance and/or exit block confirmation per vein) and procedure was not declined due to technical issues related to Phased RFA system	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	Parameters to measure the efficiency: procedure duration, laboratory occupancy duration, 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	Characterize anticoagulation therapy: activated clotting time (ACT) during the procedure. Correlate anticoagulation therapy with thromboembolic events and bleeding the peri -procedural thromboembolic events and bleeding	Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Phased RFA Catheters Used	Evaluate which tools participating centers use (MAAC (Multi-Array Ablation Catheter) and/or MASC (Multi-Array Septal Catheter) and/or PVAC GOLD) in persistent and long standing persistent AF and to verify patient's characteristics, procedure approaches and estimates outcome across participating sites. The main interest is if PVAC GOLD catheter can be utilized as a single catheter for patients with persistent AF and analyze AF recurrence rate in this group	Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
Quality of Life Dynamic - AFEQT Score at 12 Months	Quality of life will be captured using the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire. It is a standardized, disease-specific, reliable and responsive measure of health-related quality of life in subjects with AF. The AFEQT is a self-reported questionnaire with responses on a 7-point Likert scale. The 20-item instrument is divided into three domains (4-item symptom score, 8-item daily activities score, 6-item treatment concerns score) plus two treatment satisfaction questions.In countries where no validated version is available yet (e.g. Israel, Portugal), the AFEQT questionnaire will not be applied or will be additionally validated for the country official languages according to local requirements and regulations. Overall or subscale range from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability).	Patient will be followed for minimum 12 months, maximum 14 months, 12 month reported
Procedural Efficiency - Number of Catheters Used	Parameters to measure the efficiency: Phased RFA consumables used	Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
Procedural Efficiency - Number of Adjunctive Devices Used	Parameters to measure the efficiency: adjunctive devices used	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 - International Normalized Ratio (INR)	Characterize anticoagulation therapy: international normalized ratio (INR). Correlate anticoagulation therapy with thromboembolic events and bleeding the peri -procedural thromboembolic events and bleeding. The INR is derived from prothrombin time (PT) which is calculated as a ratio of the patient's PT to a control PT standardized for the potency of the thromboplastin reagent developed by the World Health Organization (WHO) using the following formula: INR = Patient PT ÷ Control PT. INR can be used to assess the risk of bleeding or the coagulation status of the patients.	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 - Percent of Participants With Previous and Peri-Procedural Anticoagulation Therapy	Characterize anticoagulation therapy: utilization of vitamin K antagonists (VKA), novel oral anticoagulants (NOAC), peri -procedural "bridging" vs "no bridging" strategy. Correlate anticoagulation therapy with thromboembolic events and bleeding the peri -procedural thromboembolic events and bleeding	Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Number Total Cardioversions	Evaluate which tools participating centers use (MAAC (Multi-Array Ablation Catheter) and/or MASC (Multi-Array Septal Catheter) and/or PVAC GOLD) in persistent and long standing persistent AF and to verify patient's characteristics, procedure approaches and estimates outcome across participating sites. The main interest is if PVAC GOLD catheter can be utilized as a single catheter for patients with persistent AF and analyze AF recurrence rate in this group	Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Percentage of Persistent AF Participants With Cardioversions for AF Within Last 12 Months	Evaluate which tools participating centers use (MAAC (Multi-Array Ablation Catheter) and/or MASC (Multi-Array Septal Catheter) and/or PVAC GOLD) in persistent and long standing persistent AF and to verify patient's characteristics, procedure approaches and estimates outcome across participating sites. The main interest is if PVAC GOLD catheter can be utilized as a single catheter for patients with persistent AF and analyze AF recurrence rate in this group	Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Percentage of Catheters Used Per Participant Procedure	Evaluate which tools participating centers use (MAAC (Multi-Array Ablation Catheter) and/or MASC (Multi-Array Septal Catheter) and/or PVAC GOLD) in persistent and long standing persistent AF and to verify patient's characteristics, procedure approaches and estimates outcome across participating sites. The main interest is if PVAC GOLD catheter can be utilized as a single catheter for patients with persistent AF and analyze AF recurrence rate in this group	Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Ablation Solutions
• Collaborators: IHF GmbH - Institut für Herzinfarktforschung
• Investigators: Principal Investigator: Lucas Boersma, MD, Ph.D, St. Antonious; Principal Investigator: Meleze Hocini, MD, Hôpital Cardiologique Du Haut-Lévêque

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): November 20, 2018
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: March 17, 2015
• First Submitted That Met QC Criteria: April 29, 2015
• First Posted (Estimated): May 5, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Pulmonary Vein Isolation; Phased Radiofrequency Ablation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: GOLD AF