NCT07777744 · University Hospital, Basel, Switzerland
Severe Complications During Ventricular Tachycardia or Premature Ventricular Complex Ablation
What this study is about
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.
View original scientific description
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.
Primary outcome measures
Descriptive characterization of patients
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Chicago, Illinois
- Michigan Center, Michigan
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 20, 2026 · Source of record for eligibility and locations