Clinical trial Recruiting at 25 sites Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment15000 (estimated)
SponsorUniversity Hospital, Basel, Switzerland
Academic / other
Locations25 sites (Chicago, Illinois and 24 other locations)
StatusRecruiting
StartedJuly 1, 2024
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedAugust 20, 2026
Trial IDNCT07777744 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

  • 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
  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.