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Studies

Observational Recruiting

NCT07777744 on ClinicalTrials.gov

Severe Complications During Ventricular Tachycardia or Premature Ventricular Complex Ablation

Official title: Severe Complications During Ventricular Tachycardia or Premature Ventricular Complex Ablation - an International Multicenter Collaborative Study Group

  • Sponsor: University Hospital of Basel
  • Enrollment: 15000 (Estimated)
  • Study start: 2024-07-01 (Actual)
  • Primary completion: 2028-12-31 (Estimated)
  • Study completion: 2028-12-31 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

The investigators aim to characterize patients presenting with a severe ventricular tachycardia (VT) and premature ventricular complex (PVC)-ablation-related complication including patient characteristics, procedural details and subsequent management of the complication by gathering existing patient-level data.

Conditions

  • Ventricular Tachycardia (VT)
  • Premature Ventricular Complexes

Primary Outcome Measures

  • Descriptive characterization of patients (up to 30 days)
    characterizing features: * hemodynamic instability requiring mechanical intensive-care management * tamponade * stroke * cardiac arrest * myocardial infarction * coronary artery dissection * phrenic nerve palsy * major bleeding as per the International Society on Thrombosis and Haemostasis (ISTH) * vascular or cardiac complication requiring surgery or interventional management (interventional radiology, angiology) * iatrogenic atrio-ventricular block requiring device implantation or upgrade. * procedure-related death

Countries

Austria, Canada, China, Croatia, France, Germany, Greece, Israel, Italy, Singapore, Slovenia, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States

Locations and Investigators

  • Rush University Medical Center, Chicago, United States (Recruiting)
    • Henry Huang
  • University of Michigan, Michigan Center, United States (Recruiting)
    • Jackson Liang
  • Medical University of Graz, Graz, Austria (Recruiting)
    • Daniel Scherr
  • Université Laval, Québec, Canada (Recruiting)
    • Jean-Francois Sarrazin
  • The First Affiliated Hospital of Nanjing Medical University, Nanjing, China (Recruiting)
    • Fengxiang Zhang
  • University Hospital Center Sestre milosrdnice, Zagreb, Croatia (Recruiting)
    • Nikola Pavlovic
  • CHU Bordeaux, Bordeaux, France (Recruiting)
    • Frederic Sacher
  • Centre Hospitalier Universitaire Trousseau, Chambray-lès-Tours, France (Recruiting)
    • Alexandre Bodin
  • University Hospital Poitier, Poitiers, France (Recruiting)
    • Rodrigue Garcia
  • Clinique Pasteur Toulouse, Toulouse, France (Recruiting)
    • Serge Boveda
  • Zentralklinik Bad Bercka, Bad Berka, Germany (Recruiting)
    • Ahmad Kelani
  • Uniklinik Freiburg, Bad Krozingen, Germany (Recruiting)
    • Heiko Lehrmann
  • Carl-Thiem-Klinikum, Cottbus, Germany (Recruiting)
    • Dirk Grosse Meininghaus
  • Universitätsklinikum Münster, Münster, Germany (Recruiting)
    • Lars Eckardt
  • University of Patras, Pátrai, Greece (Recruiting)
    • Georgios Leventopoulos
  • Sheba Medical Center, Ramat Gan, Israel (Recruiting)
    • Eyal Nof
  • Citta della Salute e della Scienza di Torino, Torino, Italy (Recruiting)
    • Matteo Anselmino
  • Mount Elisabeth Medical Centre, Singapore, Singapore (Recruiting)
    • Pipin Kojodjojo
  • University Medical Center Ljubljana, Ljubljana, Slovenia (Recruiting)
    • Andrej Pernat
  • Hospital Universitario Ramón y Cajal, Madrid, Spain (Recruiting)
    • Javier Moreno
  • University Hospital Basel, Basel, Switzerland (Recruiting)
    • Michael Kühne, Prof. Dr. med.
    • Patrick Badertscher, PD Dr. med.
    • Michael Kühne, Prof. Dr. med. (Principal Investigator)
  • Inselspital Bern, Bern, Switzerland (Recruiting)
    • Tobias Reichlin
  • Ankara City Hospital, Ankara, Turkey (Türkiye) (Recruiting)
    • Serkan Cay
  • Hacettepe University, Ankara, Turkey (Türkiye) (Recruiting)
    • Hikmet Yorgun
  • Royal Papworth Hospital, Cambridge, United Kingdom (Recruiting)
    • Claire Martin

Study Officials