Postmarket Evaluation of the Phased Radio Frequency Ablation System (GOLD AF Registry)
2020. június 3. frissítette: Medtronic Cardiac Rhythm and Heart Failure
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.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Részletes leírás
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.
Tanulmány típusa
Megfigyelő
Beiratkozás (Tényleges)
1071
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Eastbourne, Egyesült Királyság
- Eastbourne District General Hospital
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Angers, Franciaország
- CHU Angers
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Bordeaux, Franciaország
- CHU de Bordeaux
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Le Chesnay, Franciaország, 78150
- CMC Parly 2
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Saint-Denis, Franciaország
- Centre Cardiologique du Nord
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Tbilisi, Grúzia
- Jo Ann Medical Center
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Athens, Görögország
- General Hospital Alexandra
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Leeuwarden, Hollandia
- Medisch Centrum Leeuwarden B.V.
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Nieuwegein, Hollandia
- St. Antonius Ziekenhuis
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Ashkelon, Izrael
- The Barzilai Medical Center Ashkleon
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Beer-Sheva, Izrael
- Soroka University Medical Center
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Jerusalem, Izrael
- Hadassah Medical Center
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Rehovot, Izrael
- Kaplan Medical Center
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Bucheon-si, Koreai Köztársaság
- Sejong General Hospital
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Daegu, Koreai Köztársaság
- Keimyung University Dongsan Hospital
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Daegu, Koreai Köztársaság
- Yeungnam University Hospital
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Gwangju, Koreai Köztársaság
- Chonnam National University Hospital
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Seoul, Koreai Köztársaság
- Asan Medical Center
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Seoul, Koreai Köztársaság
- Samsung Medical Center
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Lublin, Lengyelország
- Samodzielny Publiczny Szpital Kliniczny nr 4
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Szczecin, Lengyelország
- Samodzielny Publiczny Szpital Kliniczny Nr 2
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Warszawa, Lengyelország
- Samodzielny Publiczny Centralny Szpital Kliniczny
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Wroclaw, Lengyelország
- 4 Wojskowy Szpital Kliniczny
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Budapest, Magyarország
- Military Hospital
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Debrecen, Magyarország
- University of Debrecen
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Dortmund, Németország
- St. Johannes Hospital
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Düsseldorf, Németország
- Evangelisches Krankenhaus
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Erfurt, Németország
- Helios Klinikum Erfurt
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Kempten, Németország
- Herz- und Gefäßzentrum Oberallgäu-Kempten
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Münster, Németország
- Universitätsklinikum Münster
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Paderborn, Németország
- St. Vincenz-Krankenhaus Paderborn
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Bergamo, Olaszország
- A.O. Papa Giovanni XXIII
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Catanzaro, Olaszország
- Az. Osped. Pugliese Ciaccio
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Legnago, Olaszország
- Ospedale Mater Salutis
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Monza, Olaszország
- A.O. Osped. S.Gerardo
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Rome, Olaszország
- A.O. San camillo Forlanini
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Lisboa, Portugália
- Centro Hospitalar Lisboa Notre - Hospital de Santa Maria E.P.E.
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Donostia, Spanyolország
- Hospital Donostia
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Madrid, Spanyolország
- Hospital General Universitario Gregorio Maranon
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Madrid, Spanyolország
- Hospital Universitario 12 de Octubre
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Zürich, Svájc
- Hirslanden Klinik St. Anna AG
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év és régebbi (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Mintavételi módszer
Nem valószínűségi minta
Tanulmányi populáció
Eligible are all patients with paroxysmal, persistent and long-standing persistent AF who fulfill all inclusion criteria.
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Estimate Phased RFA (Radio Frequency Ablation) Mid-term Success Rate
Időkeret: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
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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.
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Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Estimate Phased RFA Mid-term Safety
Időkeret: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
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Estimate major procedure/system related complications of Phased RFA
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Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Acute Procedural Success Rate
Időkeret: Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
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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
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Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
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Procedural Efficiency - Procedure Duration, Laboratory Occupancy Duration and Fluoroscopy Time
Időkeret: Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
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Parameters to measure the efficiency: procedure duration, laboratory occupancy duration, fluoroscopy time
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Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
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Peri-procedural Anticoagulation Therapy - Activated Clotting Time
Időkeret: Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
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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
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Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
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Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Phased RFA Catheters Used
Időkeret: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
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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
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Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
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Quality of Life Dynamic - AFEQT Score at 12 Months
Időkeret: Patient will be followed for minimum 12 months, maximum 14 months, 12 month reported
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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
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Procedural Efficiency - Number of Catheters Used
Időkeret: Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
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Parameters to measure the efficiency: Phased RFA consumables used
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Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
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Procedural Efficiency - Number of Adjunctive Devices Used
Időkeret: Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
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Parameters to measure the efficiency: adjunctive devices used
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Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
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Peri-procedural Anticoagulation Therapy - International Normalized Ratio (INR)
Időkeret: Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
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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.
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Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
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Peri-procedural Anticoagulation Therapy - Percent of Participants With Previous and Peri-Procedural Anticoagulation Therapy
Időkeret: Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
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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
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Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
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Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Number Total Cardioversions
Időkeret: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
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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
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Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
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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
Időkeret: Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
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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
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Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Percentage of Catheters Used Per Participant Procedure
Időkeret: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
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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
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Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Együttműködők
Nyomozók
- Kutatásvezető: Lucas Boersma, MD, Ph.D, St. Antonious
- Kutatásvezető: Meleze Hocini, MD, Hôpital Cardiologique Du Haut-Lévêque
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2015. március 1.
Elsődleges befejezés (Tényleges)
2018. november 20.
A tanulmány befejezése (Tényleges)
2019. május 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2015. március 17.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2015. április 29.
Első közzététel (Becslés)
2015. május 5.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2020. június 9.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2020. június 3.
Utolsó ellenőrzés
2020. június 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- GOLD AF
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
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