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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Centers : Centers participating in the present collaborative study group. Invitation to participate will be based either upon personal referral of one of the investigator, previous collaboration or based on a meta-analytic review of the literature published on the subject within the past 20 years.
* Patients: Females and males of \>18 years undergoing any type of VT/PVC ablation. While we will accept redo-procedure we will ask for a unique patient-identifier to link procedures belonging to the same patients together.
* Interventions: VT/PVC ablation (first intervention or re-do) as routinely performed by the participating centers
* Outcomes: Severe complications, defined as hemodynamic instability requiring mechanical intensive-care management, tamponade, stroke, cardiac arrest, myocardial infarction, phrenic nerve palsies, major bleeding requiring transfusion, vascular or cardiac complication requiring surgery, procedure-related death.
* Setting: Observational cohort studies, registries, retrospective cohort studies. Data stemming from RCTs (Randomized controlled trials) will not be collected as they likely do not represent a "real-life" setting.
* Length of follow-up: Peri-procedural complications
* Years considered: Not limited to a specific time-frame, but to reflect common ablation practices, we will focus on data from the 20 past years.
* Number of patients provided : No lower limit of patients provided per dataset or ablation volume per year to include high- as well as low-volume centers
Exclusion Criteria:
* Refusal of the center to participate.
* Less than 10 procedures available in the dataset (no case reports)
* Missing essential baseline characteristics, missing collection of sufficient details regarding each complication.
Primary outcome measure(s)
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
Trial sites (25)
Facility
City
Region
Status
Rush University Medical Center
Chicago
Illinois
Recruiting
University of Michigan
Michigan Center
Michigan
Recruiting
Medical University of Graz
Graz
Austria
Recruiting
Université Laval
Québec
Canada
Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing
China
Recruiting
University Hospital Center Sestre milosrdnice
Zagreb
Croatia
Recruiting
CHU Bordeaux
Bordeaux
France
Recruiting
Centre Hospitalier Universitaire Trousseau
Chambray-lès-Tours
France
Recruiting
University Hospital Poitier
Poitiers
France
Recruiting
Clinique Pasteur Toulouse
Toulouse
France
Recruiting
Zentralklinik Bad Bercka
Bad Berka
Germany
Recruiting
Uniklinik Freiburg
Bad Krozingen
Germany
Recruiting
Carl-Thiem-Klinikum
Cottbus
Germany
Recruiting
Universitätsklinikum Münster
Münster
Germany
Recruiting
University of Patras
Pátrai
Greece
Recruiting
Sheba Medical Center
Ramat Gan
Israel
Recruiting
Citta della Salute e della Scienza di Torino
Torino
Italy
Recruiting
Mount Elisabeth Medical Centre
Singapore
Singapore
Recruiting
University Medical Center Ljubljana
Ljubljana
Slovenia
Recruiting
Hospital Universitario Ramón y Cajal
Madrid
Spain
Recruiting
University Hospital Basel
Basel
Switzerland
Recruiting
Inselspital Bern
Bern
Switzerland
Recruiting
Ankara City Hospital
Ankara
Turkey (Türkiye)
Recruiting
Hacettepe University
Ankara
Turkey (Türkiye)
Recruiting
Royal Papworth Hospital
Cambridge
United Kingdom
Recruiting
More University Hospital, Basel, Switzerland trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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