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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Eastbourne、イギリス
- Eastbourne District General Hospital
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Ashkelon、イスラエル
- The Barzilai Medical Center Ashkleon
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Beer-Sheva、イスラエル
- Soroka University Medical Center
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Jerusalem、イスラエル
- Hadassah Medical Center
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Rehovot、イスラエル
- Kaplan Medical Center
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Bergamo、イタリア
- A.O. Papa Giovanni XXIII
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Catanzaro、イタリア
- Az. Osped. Pugliese Ciaccio
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Legnago、イタリア
- Ospedale Mater Salutis
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Monza、イタリア
- A.O. Osped. S.Gerardo
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Rome、イタリア
- A.O. San Camillo Forlanini
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Leeuwarden、オランダ
- Medisch Centrum Leeuwarden B.V.
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Nieuwegein、オランダ
- St. Antonius Ziekenhuis
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Athens、ギリシャ
- General Hospital Alexandra
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Tbilisi、グルジア
- Jo Ann Medical Center
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Zürich、スイス
- Hirslanden Klinik St. Anna AG
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Donostia、スペイン
- Hospital Donostia
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Madrid、スペイン
- Hospital General Universitario Gregorio Maranon
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Madrid、スペイン
- Hospital Universitario 12 de octubre
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Dortmund、ドイツ
- St. Johannes Hospital
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Düsseldorf、ドイツ
- Evangelisches Krankenhaus
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Erfurt、ドイツ
- Helios Klinikum Erfurt
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Kempten、ドイツ
- Herz- und Gefäßzentrum Oberallgäu-Kempten
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Münster、ドイツ
- Universitatsklinikum Munster
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Paderborn、ドイツ
- St. Vincenz-Krankenhaus Paderborn
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Budapest、ハンガリー
- Military Hospital
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Debrecen、ハンガリー
- University of Debrecen
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Angers、フランス
- Chu Angers
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Bordeaux、フランス
- CHU de Bordeaux
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Le Chesnay、フランス、78150
- CMC Parly 2
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Saint-Denis、フランス
- Centre Cardiologique du Nord
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Lisboa、ポルトガル
- Centro Hospitalar Lisboa Notre - Hospital de Santa Maria E.P.E.
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Lublin、ポーランド
- Samodzielny Publiczny Szpital Kliniczny nr 4
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Szczecin、ポーランド
- Samodzielny Publiczny Szpital Kliniczny Nr 2
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Warszawa、ポーランド
- Samodzielny Publiczny Centralny Szpital Kliniczny
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Wroclaw、ポーランド
- 4 Wojskowy Szpital Kliniczny
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Bucheon-si、大韓民国
- Sejong General Hospital
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Daegu、大韓民国
- Keimyung University Dongsan Hospital
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Daegu、大韓民国
- Yeungnam University Hospital
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Gwangju、大韓民国
- Chonnam National University Hospital
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Seoul、大韓民国
- Asan Medical Center
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Seoul、大韓民国
- Samsung Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Estimate Phased RFA (Radio Frequency Ablation) Mid-term Success Rate
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Estimate Phased RFA Mid-term Safety
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Acute Procedural Success Rate
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
|
Quality of Life Dynamic - AFEQT Score at 12 Months
時間枠：Patient will be followed for minimum 12 months, maximum 14 months, 12 month reported
|
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
時間枠：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
時間枠：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)
時間枠：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
時間枠：Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
|
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
時間枠：Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
|
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
時間枠：Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
|
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
時間枠：Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
|
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
|
協力者と研究者
捜査官
- 主任研究者：Lucas Boersma, MD, Ph.D、St. Antonious
- 主任研究者：Meleze Hocini, MD、Hôpital Cardiologique Du Haut-Lévêque
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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