Ventricular Tachycardia (VT)NCT07777744
Severe Complications During Ventricular Tachycardia or Premature Ventricular Complex Ablation
An observational study of Ventricular Tachycardia (VT) and Premature Ventricular Complexes, run by University Hospital, Basel, Switzerland at 25 sites in 16 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia (VT), Premature Ventricular Complexes
- How many people
- 15,000 participants
- Where
- 25 sitesin 16 countries
- Study dates
- 1 Jul 2024to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with a severe VT/PVC-ablation-related complication
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
25 sites in 16 countries. Contact the study team or a site near you to ask about taking part.
Patrick Badertscher, PD Dr. med. contact
25 sites in 16 countries
France4 sites, 4 recruiting
- Recruiting
CHU Bordeaux
Bordeaux
Frederic Sacher, +33 9 78 33 20 13
- Recruiting
Centre Hospitalier Universitaire Trousseau
Chambray-lès-Tours
Alexandre Bodin, +33 2 47 47 47 47, alexandrebodin.mail@gmail.com
- Recruiting
University Hospital Poitier
Poitiers
Rodrigue Garcia, +33 5 49 44 44 44, rodrigue.garcia@chu-poitiers.fr
- Recruiting
Clinique Pasteur Toulouse
Toulouse
Serge Boveda, +33 5 62 21 31 31, sboveda@clinique-pasteur.com
Germany4 sites, 4 recruiting
- Recruiting
Zentralklinik Bad Bercka
Bad Berka
Ahmad Kelani, +49 36458 50, a_kelani@hotmail.com
- Recruiting
Uniklinik Freiburg
Bad Krozingen
Heiko Lehrmann, +49 7633 402-4300, heiko.lehrmann@uniklinik-freiburg.de
- Recruiting
Carl-Thiem-Klinikum
Cottbus
Dirk Grosse Meininghaus, +49 355 460, dirk_gm@icloud.com
- Recruiting
Universitätsklinikum Münster
Münster
Lars Eckardt, +49 251 83-47581, Lars.Eckardt@ukmuenster.de
United States2 sites, 2 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Henry Huang, 312-942-5000, henry.huang@bsd.uchicago.edu
- Recruiting
University of Michigan
Michigan Center, Michigan, 48109
Jackson Liang, 734-936-4000, liangjac@med.umich.edu
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Michael Kühne, Prof. Dr. med., +41 61 265 52 14, Michael.kuehne@usb.ch
Patrick Badertscher, PD Dr. med.
- Recruiting
Inselspital Bern
Bern
Tobias Reichlin, +41 31 632 21 11, tobias.reichlin@insel.ch
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Ankara City Hospital
Ankara
Serkan Cay, +90 312 552 60 00, cayserkan@yahoo.com
- Recruiting
Hacettepe University
Ankara
Hikmet Yorgun, +90 312 305 10 80, hikmet.yorgun@hacettepe.edu.tr
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz
Graz
Daniel Scherr, +43 316 385 0, daniel.scherr@medunigraz.at
Canada1 site, 1 recruiting
- Recruiting
Université Laval
Québec
Jean-Francois Sarrazin, 418-656-2131, jean-francois.sarrazin@criucpq.ulaval.ca
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing
Fengxiang Zhang, +86 25 8359 2526, njzfx6@njmu.edu.cn
Croatia1 site, 1 recruiting
- Recruiting
University Hospital Center Sestre milosrdnice
Zagreb
Nikola Pavlovic, +385 1 3787 111, nikolap12@yahoo.com
Greece1 site, 1 recruiting
- Recruiting
University of Patras
Pátrai
Georgios Leventopoulos, +30 261 099 6683, levent2669@gmail.com
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Eyal Nof, +972-77-996-6905, eyalnof.dr@gmail.com
Italy1 site, 1 recruiting
- Recruiting
Citta della Salute e della Scienza di Torino
Torino
Matteo Anselmino, +39 011 633 1633, matteo.anselmino@unito.it
Singapore1 site, 1 recruiting
- Recruiting
Mount Elisabeth Medical Centre
Singapore
Pipin Kojodjojo, +65 6250 0000, drko.pipin@ahvc.com.sg
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Center Ljubljana
Ljubljana
Andrej Pernat, +386 1 522 50 50, andrej.pernat@kclj.si
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid
Javier Moreno, +34 913 36 80 00, jmoreno@secardiologia.es
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Papworth Hospital
Cambridge
Claire Martin, +44 1223 638000, claire.martin22@nhs.net
About this study
Official title: Severe Complications During Ventricular Tachycardia or Premature Ventricular Complex Ablation - an International Multicenter Collaborative Study Group
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.
- Keywords
- Ablation
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Premature Complexes
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 30 days
Secondary outcomes (4)
Prevalence of each severe complication
Measured: up to 30 days
Difference in baseline characteristics between the patients who experienced a complication and the ones who did not
Measured: up to 30 days
The contribution of important baseline and procedural characteristics to the occurrence of a severe complication
Measured: up to 30 days
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)
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Jul 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Tachycardia (VT)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Kühne, Prof. Dr. med., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777744
- Sponsor's protocol ID
- 2024-00843; kt26badertscher
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Complications During Ventricular Tachycardia or Premature Ventricular Complex Ablation - an International Multicenter Collaborative Study Group
- ClinicalTrials.gov ID
- NCT07777744
- Acronym / sponsor ID
- 2024-00843; kt26badertscher
- Keywords
- Ablation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with a severe VT/PVC-ablation-related complication
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Prevalence of each severe complication
Time frame: up to 30 days
Difference in baseline characteristics between the patients who experienced a complication and the ones who did not
Time frame: up to 30 days
The contribution of important baseline and procedural characteristics to the occurrence of a severe complication
Time frame: up to 30 days
Impact of center-specific data on the occurrence and management of these complications
Time frame: up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Undecided
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MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Badertscher, PD Dr. med. contact
Michael Kühne, Prof. Dr. med. principal investigator
University Hospital, Basel, Switzerland
25 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia (VT) and Premature Ventricular Complexes, run by University Hospital, Basel, Switzerland at 25 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in France, Germany, United States, Switzerland, Turkey (Türkiye) and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Kühne, Prof. Dr. med. (0041 61 265 52 14, Michael.kuehne@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive characterization of patients (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.