Clinical trial NCT02433613: Postmarket Evaluation of the Phased Radio Frequency Ablation System (GOLD AF Registry)
Official title: Postmarket Evaluation of the Phased Radio Frequency Ablation System (GOLD AF Registry)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Pulmonary Vein Isolation
Phased Radiofrequency Ablation
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
Collaborators: name: IHF GmbH - Institut für Herzinfarktforschung
First posted: 2015-05-05
Enrollment: 1071
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible are all patients with paroxysmal, persistent and long-standing persistent AF who fulfill all inclusion criteria.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Estimate Phased RFA (Radio Frequency Ablation) Mid-term Success Rate
timeFrame: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
Secondary outcomes:
measure: Estimate Phased RFA Mid-term Safety
timeFrame: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
Other outcomes:
measure: Acute Procedural Success Rate
timeFrame: Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
measure: Procedural Efficiency - Procedure Duration, Laboratory Occupancy Duration and Fluoroscopy Time
timeFrame: Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
measure: Peri-procedural Anticoagulation Therapy - Activated Clotting Time
timeFrame: Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
measure: Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Phased RFA Catheters Used
timeFrame: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
measure: Quality of Life Dynamic - AFEQT Score at 12 Months
timeFrame: Patient will be followed for minimum 12 months, maximum 14 months, 12 month reported
measure: Procedural Efficiency - Number of Catheters Used
timeFrame: Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
measure: Procedural Efficiency - Number of Adjunctive Devices Used
timeFrame: Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
measure: Peri-procedural Anticoagulation Therapy - International Normalized Ratio (INR)
timeFrame: Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
measure: Peri-procedural Anticoagulation Therapy - Percent of Participants With Previous and Peri-Procedural Anticoagulation Therapy
timeFrame: Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
measure: Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Number Total Cardioversions
timeFrame: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
measure: 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
timeFrame: Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
measure: Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Percentage of Catheters Used Per Participant Procedure
timeFrame: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
Locations:
city: Angers
country: France
facility: CHU Angers
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Le Chesnay
country: France
facility: CMC Parly 2
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord
city: Tbilisi
country: Georgia
facility: Jo Ann Medical Center
city: Dortmund
country: Germany
facility: St. Johannes Hospital
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
city: Kempten
country: Germany
facility: Herz- und Gefäßzentrum Oberallgäu-Kempten
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Paderborn
country: Germany
facility: St. Vincenz-Krankenhaus Paderborn
city: Athens
country: Greece
facility: General Hospital Alexandra
city: Budapest
country: Hungary
facility: Military Hospital
city: Debrecen
country: Hungary
facility: University of Debrecen
city: Ashkelon
country: Israel
facility: The Barzilai Medical Center Ashkleon
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Bergamo
country: Italy
facility: A.O. Papa Giovanni XXIII
city: Catanzaro
country: Italy
facility: Az. Osped. Pugliese Ciaccio
city: Legnago
country: Italy
facility: Ospedale Mater Salutis
city: Monza
country: Italy
facility: A.O. Osped. S.Gerardo
city: Rome
country: Italy
facility: A.O. San Camillo Forlanini
city: Bucheon-si
country: Korea, Republic of
facility: Sejong General Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden B.V.
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 4
city: Szczecin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 2
city: Warszawa
country: Poland
facility: Samodzielny Publiczny Centralny Szpital Kliniczny
city: Wroclaw
country: Poland
facility: 4 Wojskowy Szpital Kliniczny
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Notre - Hospital de Santa Maria E.P.E.
city: Donostia
country: Spain
facility: Hospital Donostia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Zürich
country: Switzerland
facility: Hirslanden Klinik St. Anna AG
city: Eastbourne
country: United Kingdom
facility: Eastbourne District General Hospital
Study officials:
affiliation: St. Antonious
name: Lucas Boersma, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Cardiologique du Haut-Lévêque
name: Meleze Hocini, MD
role: PRINCIPAL_INVESTIGATOR
References: