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

3 de junho de 2020 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Real)

1071

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Dortmund, Alemanha
        • St. Johannes Hospital
      • Düsseldorf, Alemanha
        • Evangelisches Krankenhaus
      • Erfurt, Alemanha
        • Helios Klinikum Erfurt
      • Kempten, Alemanha
        • Herz- und Gefäßzentrum Oberallgäu-Kempten
      • Münster, Alemanha
        • Universitatsklinikum Munster
      • Paderborn, Alemanha
        • St. Vincenz-Krankenhaus Paderborn
  • Espanha
      • Donostia, Espanha
        • Hospital Donostia
      • Madrid, Espanha
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Espanha
        • Hospital Universitario 12 de octubre
  • França
      • Angers, França
        • Chu Angers
      • Bordeaux, França
        • CHU de Bordeaux
      • Le Chesnay, França, 78150
        • CMC Parly 2
      • Saint-Denis, França
        • Centre Cardiologique du Nord
  • Geórgia
      • Tbilisi, Geórgia
        • Jo Ann Medical Center
  • Grécia
      • Athens, Grécia
        • General Hospital Alexandra
  • Holanda
      • Leeuwarden, Holanda
        • Medisch Centrum Leeuwarden B.V.
      • Nieuwegein, Holanda
        • St. Antonius Ziekenhuis
  • Hungria
      • Budapest, Hungria
        • Military Hospital
      • Debrecen, Hungria
        • University of Debrecen
  • Israel
      • Ashkelon, Israel
        • The Barzilai Medical Center Ashkleon
      • Beer-Sheva, Israel
        • Soroka University Medical Center
      • Jerusalem, Israel
        • Hadassah Medical Center
      • Rehovot, Israel
        • Kaplan Medical Center
  • Itália
      • Bergamo, Itália
        • A.O. Papa Giovanni XXIII
      • Catanzaro, Itália
        • Az. Osped. Pugliese Ciaccio
      • Legnago, Itália
        • Ospedale Mater Salutis
      • Monza, Itália
        • A.O. Osped. S.Gerardo
      • Rome, Itália
        • A.O. San Camillo Forlanini
  • Polônia
      • Lublin, Polônia
        • Samodzielny Publiczny Szpital Kliniczny nr 4
      • Szczecin, Polônia
        • Samodzielny Publiczny Szpital Kliniczny Nr 2
      • Warszawa, Polônia
        • Samodzielny Publiczny Centralny Szpital Kliniczny
      • Wroclaw, Polônia
        • 4 Wojskowy Szpital Kliniczny
  • Portugal
      • Lisboa, Portugal
        • Centro Hospitalar Lisboa Notre - Hospital de Santa Maria E.P.E.
  • Reino Unido
      • Eastbourne, Reino Unido
        • Eastbourne District General Hospital
  • Republica da Coréia
      • Bucheon-si, Republica da Coréia
        • Sejong General Hospital
      • Daegu, Republica da Coréia
        • Keimyung University Dongsan Hospital
      • Daegu, Republica da Coréia
        • Yeungnam University Hospital
      • Gwangju, Republica da Coréia
        • Chonnam National University Hospital
      • Seoul, Republica da Coréia
        • Asan Medical Center
      • Seoul, Republica da Coréia
        • Samsung Medical Center
  • Suíça
      • Zürich, Suíça
        • Hirslanden Klinik St. Anna AG

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Eligible are all patients with paroxysmal, persistent and long-standing persistent AF who fulfill all inclusion criteria.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Estimate Phased RFA (Radio Frequency Ablation) Mid-term Success Rate
Prazo: 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.
Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Estimate Phased RFA Mid-term Safety
Prazo: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
Estimate major procedure/system related complications of Phased RFA
Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Acute Procedural Success Rate
Prazo: Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
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
Procedural Efficiency - Procedure Duration, Laboratory Occupancy Duration and Fluoroscopy Time
Prazo: Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
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
Peri-procedural Anticoagulation Therapy - Activated Clotting Time
Prazo: Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
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
Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Phased RFA Catheters Used
Prazo: 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
Quality of Life Dynamic - AFEQT Score at 12 Months
Prazo: 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
Procedural Efficiency - Number of Catheters Used
Prazo: Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
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
Procedural Efficiency - Number of Adjunctive Devices Used
Prazo: Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
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
Peri-procedural Anticoagulation Therapy - International Normalized Ratio (INR)
Prazo: Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration
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
Peri-procedural Anticoagulation Therapy - Percent of Participants With Previous and Peri-Procedural Anticoagulation Therapy
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Medtronic Cardiac Rhythm and Heart Failure

Colaboradores

IHF GmbH - Institut für Herzinfarktforschung

Investigadores

  • Investigador principal: Lucas Boersma, MD, Ph.D, St. Antonious
  • Investigador principal: Meleze Hocini, MD, Hôpital Cardiologique Du Haut-Lévêque

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de março de 2015

Conclusão Primária (Real)

20 de novembro de 2018

Conclusão do estudo (Real)

1 de maio de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

17 de março de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de abril de 2015

Primeira postagem (Estimativa)

5 de maio de 2015

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de junho de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de junho de 2020

Última verificação

1 de junho de 2020

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • GOLD AF

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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