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NCT Number: NCT07777744

Severe Complications During Ventricular Tachycardia or Premature Ventricular Complex Ablation

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Prevalence of each severe complication

    Time frame: up to 30 days

  2. Difference in baseline characteristics between the patients who experienced a complication and the ones who did not

    Time frame: up to 30 days

  3. The contribution of important baseline and procedural characteristics to the occurrence of a severe complication

    Time frame: up to 30 days

  4. Impact of center-specific data on the occurrence and management of these complications

    Time frame: up to 30 days

    Case-load of the centers, number of electrophysiologists, geographic hospital location, routine use of ICE (Intracardiac Echocardiography)

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Kühne, Prof. Dr. med.

CONTACT

[email protected]

0041 61 265 52 14

Patrick Badertscher, PD Dr. med.

CONTACT

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Severe Complications During Ventricular Tachycardia or Premature Ventricular Complex Ablation - an International Multicenter Collaborative Study Group

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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