Severe Complications During Ventricular Tachycardia or Premature Ventricular Complex Ablation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients presenting with a severe VT/PVC-ablation-related complication
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Descriptive characterization of patients
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
Time frame
up to 30 daysSecondary outcomes
1
Prevalence of each severe complication
Time frame
up to 30 days2
Difference in baseline characteristics between the patients who experienced a complication and the ones who did not
Time frame
up to 30 days3
The contribution of important baseline and procedural characteristics to the occurrence of a severe complication
Time frame
up to 30 days4
Impact of center-specific data on the occurrence and management of these complications
Case-load of the centers, number of electrophysiologists, geographic hospital location, routine use of ICE (Intracardiac Echocardiography)
Time frame
up to 30 daysSponsors and contacts
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Source ClinicalTrials.gov