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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02433613
• Other study ID #: GOLD AF
• Status: Completed
• Start date: March 2015
• Est. completion date: May 2019

Study information

• Verified date: June 2020
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1071
• Est. completion date: May 2019
• Est. primary completion date: November 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHU de Bordeaux	Bordeaux
France	CMC Parly 2	Le Chesnay
France	Centre Cardiologique du Nord	Saint-Denis
Georgia	Jo Ann Medical Center	Tbilisi
Germany	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
Greece	General Hospital Alexandra	Athens
Hungary	Military Hospital	Budapest
Hungary	University of Debrecen	Debrecen
Israel	The Barzilai Medical Center Ashkleon	Ashkelon
Israel	Soroka University Medical Center	Beer-Sheva
Israel	Hadassah Medical Center	Jerusalem
Israel	Kaplan Medical Center	Rehovot
Italy	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
Korea, Republic of	Sejong General Hospital	Bucheon-si
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Yeungnam University Hospital	Daegu
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Netherlands	Medisch Centrum Leeuwarden B.V.	Leeuwarden
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 4	Lublin
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 2	Szczecin
Poland	Samodzielny Publiczny Centralny Szpital Kliniczny	Warszawa
Poland	4 Wojskowy Szpital Kliniczny	Wroclaw
Portugal	Centro Hospitalar Lisboa Notre - Hospital de Santa Maria E.P.E.	Lisboa
Spain	Hospital Donostia	Donostia
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Switzerland	Hirslanden Klinik St. Anna AG	Zürich
United Kingdom	Eastbourne District General Hospital	Eastbourne

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure	IHF GmbH - Institut für Herzinfarktforschung

Countries where clinical trial is conducted

France,  Georgia,  Germany,  Greece,  Hungary,  Israel,  Italy,  Korea, Republic of,  Netherlands,  Poland,  Portugal,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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