Clinical Trials in Canada / NCT07777744
Recruiting
Observational
Severe Complications During Ventricular Tachycardia or Premature Ventricular Complex Ablation
NCT07777744 · tracked via the Priya Life Science Canada tracker
Condition(s) studied
Ventricular Tachycardia (VT)Premature Ventricular Complexes
Study 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.
Eligibility
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 Canada
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Official registry record
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.
View NCT07777744 on ClinicalTrials.gov ↗ ← All trials in Canada