Trial document





This trial has been registered retrospectively.
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  DRKS00016006

Trial Description

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Title

Mediastinal and esophageal alterations after pulmonary vein isolation

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Trial Acronym

MADE-PVI

(Mediastino-esophageal Alterations Detected Endosonographically after Pulmonary Vein Isolation)

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URL of the Trial

http://entfällt

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Brief Summary in Lay Language

Atrial fibrillation is the most common heart rhythm disorder with life-time risk of 25%. Catheter ablation of atrial fibrillation is an established way to treat symptomatic patients suffering of atrial fibrillation. Due to the vicinity of the left atrium to the esophagus, damages of the esophagus may occur. These damages range from mild changes that occur in a quarter of the patients to life-threatening and rare forms such as a connection between the esophagus and the left atrium (atrioesophageal fistulas). However, there is no systematic study that investigates damages of the esophagus and surrounding (mediastinal) changes after catheter ablation of atrial fibrillation.
Therefore, purpose of this study is to investigate potential changes of the mediastinum or the esophagus by using endoscopy and endosonography after catheter ablation of atrial fibrillation. Results of this study may help to elucidate the risk of esophageal and mediastinal damages and to find ways how to minimize potential life-threatening complications.

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Brief Summary in Scientific Language

Atrial fibrillation is the most common heart rhythm disorder with life-time prevalence of 25%. Due to the chaotic movements of both atria during atrial fibrillation, ventricular function may be impaired, which subsequently can lead to dyspnea. Due to the irregular heartbeat, palpitations may occur. These factors significantly reduce quality of life. Furthermore, risk of thrombus formation and consequent systemic embolism (in particular stroke) increases. As a result, atrial fibrillation is one of the major causes for morbidity and mortality in older patients.
Besides oral anticoagulation and medical antiarrhythmic therapy, catheter ablation of atrial fibrillation is an established way to treat symptomatic patients suffering of atrial fibrillation. The pulmonary veins are one of the most important triggers for atrial fibrillation. Therefore, electrical isolation of the pulmonary veins is the standard procedure when treating patients catheter-based. Even though pulmonary vein isolation is a safe procedure with low periprocedural risks, severe complications such as pericardial effusion or stroke may occur. With a prevalence of less than 0.05% but a mortality of 70%, one of the most feared complications is the formation of a fistula between the left atrium and the esophagus that can occur due to the vicinity of the left atrium to the esophagus. Previous studies demonstrated that the risk of peri-esophageal and mediastinal changes such as edema, fibrotic changes and mucosa ulcerations occur in approx. 25%. As a result, chronic esophageal, gastrointestinal and mediastinal symptoms or diseases may follow. There are different energy sources with a similar efficacy that are established for catheter ablation of atrial fibrillation such as cryo- and radiofrequency energy.
Purpose of this study was to investigate (peri-) esophageal and mediastinal changes after pulmonary vein isolation employing endoscopy and endosonography and to correlate these alterations with potential risk factors such as age, gender, comorbidities or ablation strategy. To examine the long term outcome and to correlate the alterations found by endosonography with the symptoms of the patients, the patients are followed up to 6 months by interviews.
To summarize, this study investigates the occurrence of mediastinal and esophageal changes after catheter ablation of atrial fibrillation. Therefore, endoscopy and endosonography of the upper gastrointestinal tract is performed just before and the day after the ablation procedure. Results of this study may help to elucidate the risk of esophageal and mediastinal damages and to find ways how to minimize potential life-threatening complications.

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Organizational Data

  •   DRKS00016006
  •   2018/12/17
  •   [---]*
  •   yes
  •   Approved
  •   2017-325-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

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Health Condition or Problem studied

  •   I48.0 -  Paroxysmal atrial fibrillation
  •   I48.1 -  Persistent atrial fibrillation
  •   I48.2 -  Chronic atrial fibrillation
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Interventions/Observational Groups

  •   Esophagogastroscopy and endosonography before and after PVI (Pulmonary Vein Isolation)
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Esophageal, paraesophageal and mediastinal alterations and complications after pulmonary vein isolation

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Secondary Outcome

Atrio-esophago Fistula, esophageal ulceration, mediastinal fibrosis, mediastinal edema, hospitalisation within 30 days after PVI, 30-days mortality, cardial complications, post-procedure femural access site complications

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/01/02
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

Full legal capacity of the patient, clinical indication for pulmonary vein isolation, voluntary participation and signed written informed consent

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Exclusion Criteria

esophageal pathologies, prior pulmonary vein Isolation, contraindication for esophagogastroscopy / endosonography, pregnancy or breast-feeding, refusal of participation

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Addresses

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    • Universitätsklinikum Münster;Klinik für Kardiologie II – Rhythmologie
    • Mr.  Prof. Dr. med.   Lars  Eckardt 
    • Domagkstraße 5
    • 48149  Münster
    • Germany
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    • Universitätsklinikum MünsterMedizinische Klinik B für Gastroenterologie und Hepatologie
    • Ms.  Dr. med.   Anna Friederike   Cordes 
    • Domagkstraße 5
    • 48149  Münster
    • Germany
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    • Universitätsklinikum Münster;Klinik für Kardiologie II - Rhythmologie
    • Mr.  Prof. Dr. med.   Lars  Eckardt 
    • Domagkstraße 5
    • 48149  Münster
    • Germany
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    • Universitätsklinikum Münster; Klinik für Kardiologie II - Rhythmologie
    • Mr.  Prof. Dr. med.   Lars  Eckardt 
    • Domagkstraße 5
    • 48149  Münster
    • Germany
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Sources of Monetary or Material Support

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    • Medtronic InternationalTrading Sàrl
    • Route du Molliau 31
    • CH-1131  Tolochenaz
    • Switzerland
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.