Postmarket Evaluation of the Phased Radio Frequency Ablation System (GOLD AF Registry)
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT02433613
- Lead Sponsor
- Medtronic Cardiac Ablation Solutions
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1071
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Estimate Phased RFA (Radio Frequency Ablation) Mid-term Success Rate Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA 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.
- Secondary Outcome Measures
Name Time Method Estimate Phased RFA Mid-term Safety Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA Estimate major procedure/system related complications of Phased RFA
Trial Locations
- Locations (41)
Soroka University Medical Center
🇮🇱Beer-Sheva, Israel
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Sejong General Hospital
🇰🇷Bucheon-si, Korea, Republic of
Universitätsklinikum Münster
🇩🇪Münster, Germany
Military Hospital
🇭🇺Budapest, Hungary
Herz- und Gefäßzentrum Oberallgäu-Kempten
🇩🇪Kempten, Germany
Evangelisches Krankenhaus
🇩🇪Düsseldorf, Germany
The Barzilai Medical Center Ashkleon
🇮🇱Ashkelon, Israel
Jo Ann Medical Center
🇬🇪Tbilisi, Georgia
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
Az. Osped. Pugliese Ciaccio
🇮🇹Catanzaro, Italy
Ospedale Mater Salutis
🇮🇹Legnago, Italy
Centre Cardiologique du Nord
🇫🇷Saint-Denis, France
Yeungnam University Hospital
🇰🇷Daegu, Korea, Republic of
Samodzielny Publiczny Szpital Kliniczny Nr 4
🇵🇱Lublin, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 2
🇵🇱Szczecin, Poland
A.O. Papa Giovanni XXIII
🇮🇹Bergamo, Italy
A.O. Osped. S.Gerardo
🇮🇹Monza, Italy
Centro Hospitalar Lisboa Notre - Hospital de Santa Maria E.P.E.
🇵🇹Lisboa, Portugal
Hadassah Medical Center
🇮🇱Jerusalem, Israel
Hirslanden Klinik St. Anna AG
🇨🇭Zürich, Switzerland
Kaplan Medical Center
🇮🇱Rehovot, Israel
Eastbourne District General Hospital
🇬🇧Eastbourne, United Kingdom
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
St. Vincenz-Krankenhaus Paderborn
🇩🇪Paderborn, Germany
Helios Klinikum Erfurt
🇩🇪Erfurt, Germany
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
A.O. San Camillo Forlanini
🇮🇹Rome, Italy
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
General Hospital Alexandra
🇬🇷Athens, Greece
Medisch Centrum Leeuwarden B.V.
🇳🇱Leeuwarden, Netherlands
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
CHU Angers
🇫🇷Angers, France
CMC Parly 2
🇫🇷Le Chesnay, France
CHU de Bordeaux
🇫🇷Bordeaux, France
St. Johannes Hospital
🇩🇪Dortmund, Germany
University of Debrecen
🇭🇺Debrecen, Hungary
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Samodzielny Publiczny Centralny Szpital Kliniczny
🇵🇱Warszawa, Poland
Hospital Donostia
🇪🇸Donostia, Spain
4 Wojskowy Szpital Kliniczny
🇵🇱Wroclaw, Poland