Severe Complications During VT/PVC Ablation
Official title: Severe Complications During Ventricular Tachycardia or Premature Ventricular Complex Ablation - an International Multicenter Collaborative Study Group
Run by University Hospital, Basel, Switzerland · NCT07777744 · Data updated 2026-11-12
This study looks at real-world cases to see what severe complications occur during VT or PVC ablations and how patients are managed afterward.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 15000 (estimated) |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 25 sites (Chicago, Illinois and 24 other locations) |
| Status | Recruiting |
| Started | July 1, 2024 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | August 20, 2026 |
| Trial ID | NCT07777744 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 undergoing any type of VT or PVC ablation at participating centers.
✕Probably not a fit
Patients whose procedures do not result in severe complications may not contribute to the primary learnings about complication management.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects patient-level data from multiple centers to characterize characteristics, procedural details, and subsequent management of severe complications arising from VT/PVC ablation. It includes adults undergoing VT/PVC ablation, with a focus on events like hemodynamic collapse, tamponade, stroke, or other major complications. Data are gathered from participating centers and linked over time through unique patient identifiers. No specific intervention is being tested; the aim is to describe past events and their outcomes to inform future practice. The study involves centers in the United States and Europe and is led by a Swiss university hospital with collaboration from several major academic centers.
Why it matters
Potential benefit: Findings could help clinicians identify risk factors and improve management strategies for severe complications after VT/PVC ablation.
How similar studies have gone: Previous work in this area has shown that characterizing complications from ablation can inform safer practices, though this exact multi-center observational approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 it's running
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Rush University Medical Center
Chicago, Illinois, United States Recruiting -
University of Michigan
Michigan Center, Michigan, United States 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
Show 19 more locations
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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
Study contacts
- Principal investigator: Michael Kühne, Prof. Dr. med. — University Hospital, Basel, Switzerland
- Study coordinator: Michael Kühne, Prof. Dr. med.
- Email: Michael.kuehne@usb.ch
- Phone: 0041 61 265 52 14
Similar studies
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Non-invasive mapping to help treat ventricular tachycardia due to heart disease
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-
Personalised VT substrate mapping with dynamic voltage mapping during ablation
A procedure study to see if using dynamic voltage mapping during VT ablation helps identify and treat scar-related electrical circuits in people with ventricular tachycardia.
-
Catheter ablation vs. anti-arrhythmic drugs for PVCs
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.