Ventricular ArrythmiaMATRIX-VTNCT05964660
Echocardiography-based Motion Integration and Management for Substrate Characterization and STAR Therapy in Ventricular Tachycardias
An observational study of Ventricular Arrythmia, run by University of Luebeck at 1 site in Germany.
Trial summary
Prospective, observational, single center, pilot study to analyze the feasibility of motion and structural data integration in patients with ventricular arrhythmia by means of artificial intelligence for improved arrhythmogenic substrate characterization and motion management during stereotactic arrhythmia… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventricular Arrythmia
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 14 Aug 2023to Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 20 patients with indication for catheter ablation of ventricular arrhythmia (VA) (ventricular tachycardia (VT), ventricular fibrillation (VF), premature ventricular contraction (PVC)) and for preprocedural contract-enhanced cardiac computed tomography (CT) for cardiac structure characterization will be prospectively enrolled in the study. The therapeutic approach follows the current clinical standard.
Who may be able to join
- Age ≥ 18 years
- Indication for catheter ablation of ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia, premature ventricular contractions)
- Indication for preprocedural contrast-enhanced cardiac computed tomography for cardiac structure characterization
Who cannot join
- Platelet count < 100,000 cells/mm3
- BMI > 45 kg/m2 or < 18 kg/m2
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinik für Rhythmologie
Lübeck, Schleswig-Holstein, 23538
Roland R Tilz, Prof. Dr.med, 0049451500 ext. 44533, roland.tilz@uksh.de
Mirco Kuechler, 0049451500 ext. 77075, mirco.kuechler@uksh.de
About this study
Official title: New 3D-echocardiography-based Motion Integration and mAnagement for subsTrate characteRisation and Stereotactic Arrhythmia radIoablation tX in Ventricular Tachycardias- the MATRIX-VT Study
Prospective, observational, single center, pilot study to analyze the feasibility of motion and structural data integration in patients with ventricular arrhythmia by means of artificial intelligence for improved arrhythmogenic substrate characterization and motion management during stereotactic arrhythmia radioablation.
Read the detailed description
This is a prospective, observational, single center, pilot study. Data from preprocedural contrast-enhanced cardiac computed tomography and optically-tracked 3D transthoracic echocardiography of patients receiving catheter ablation for ventricular arrhythmia will be analyzed by means of artificial intelligence in order to better characterize the ventricular arrhythmogenic substrate and to improve the definition methods of the planning target volume during the stereotactic arrhythmia radioablation therapy by integrating the motion data into volume demarcation.
- Conditions
- Ventricular Arrythmia
- Keywords
- Ventricular arrhythmia, Ventricular tachycardia, Stereotactic arrhythmia radioablation, Artificial intelligence, Motion management, Motion integration
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VT Patients | Patients with indication for catheter ablation of ventricular arrhythmia and preprocedural contrast-enhanced cardiac computed tomography for cardiac structure characterization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of algorithm training to achieve improved arrhythmogenic substrate characterization
The feasibility of training the artificial intelligence-based algorithm using the preprocedural contrast-enhanced cardiac computed tomography and optically-tracked 3D transthoracic echocardiography data to better define the ventricular arrhythmogenic substrate in patients exhibiting ventricular arrhythmias.
Measured: 1 month after complete data collection
Feasibility of algorithm training to improve the planning target volume definition for stereotactic arrhythmia radioablation therapy
The feasibility of training the artificial intelligence-based algorithm using the preprocedural contrast-enhanced cardiac computed tomography and optically-tracked 3D transthoracic echocardiography data to better define the planning target volume for stereotactic arrhythmia radioablation therapy
Measured: 1 month after complete data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start14 Aug 2023
- Primary completionOct 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrythmiaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Robotics and Cognitive Systems, University of Luebeck, Germany
- Responsible party
- Principal investigator, Prof. Roland Richard Tilz, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964660
- Sponsor's protocol ID
- MATRIX-VT
- Acronym
- MATRIX-VT
- Status last verified
- Aug 2024
- First submitted
- 19 Jul 2023
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New 3D-echocardiography-based Motion Integration and mAnagement for subsTrate characteRisation and Stereotactic Arrhythmia radIoablation tX in Ventricular Tachycardias- the MATRIX-VT Study
- ClinicalTrials.gov ID
- NCT05964660
- Acronym / sponsor ID
- MATRIX-VT / MATRIX-VT
- Conditions
- Ventricular Arrythmia
- Keywords
- Ventricular arrhythmia, Ventricular tachycardia, Stereotactic arrhythmia radioablation, Artificial intelligence, Motion management, Motion integration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Collaborators
- Institute for Robotics and Cognitive Systems, University of Luebeck, Germany
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 28 Jul 2023 (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.
Prospective, observational, single center, pilot study to analyze the feasibility of motion and structural data integration in patients with ventricular arrhythmia by means of artificial intelligence for improved arrhythmogenic substrate characterization and motion management during stereotactic arrhythmia radioablation.
Detailed description
This is a prospective, observational, single center, pilot study. Data from preprocedural contrast-enhanced cardiac computed tomography and optically-tracked 3D transthoracic echocardiography of patients receiving catheter ablation for ventricular arrhythmia will be analyzed by means of artificial intelligence in order to better characterize the ventricular arrhythmogenic substrate and to improve the definition methods of the planning target volume during the stereotactic arrhythmia radioablation therapy by integrating the motion data into volume demarcation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VT Patients | – | –Patients with indication for catheter ablation of ventricular arrhythmia and preprocedural contrast-enhanced cardiac computed tomography for cardiac structure characterization. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 20 patients with indication for catheter ablation of ventricular arrhythmia (VA) (ventricular tachycardia (VT), ventricular fibrillation (VF), premature ventricular contraction (PVC)) and for preprocedural contract-enhanced cardiac computed tomography (CT) for cardiac structure characterization will be prospectively enrolled in the study. The therapeutic approach follows the current clinical standard.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Indication for catheter ablation of ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia, premature ventricular contractions)
- Indication for preprocedural contrast-enhanced cardiac computed tomography for cardiac structure characterization
Key exclusion criteria (2 listed)
- Platelet count < 100,000 cells/mm3
- BMI > 45 kg/m2 or < 18 kg/m2
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
Feasibility of algorithm training to achieve improved arrhythmogenic substrate characterization
Time frame: 1 month after complete data collection
The feasibility of training the artificial intelligence-based algorithm using the preprocedural contrast-enhanced cardiac computed tomography and optically-tracked 3D transthoracic echocardiography data to better define the ventricular arrhythmogenic substrate in patients exhibiting ventricular arrhythmias.
Feasibility of algorithm training to improve the planning target volume definition for stereotactic arrhythmia radioablation therapy
Time frame: 1 month after complete data collection
The feasibility of training the artificial intelligence-based algorithm using the preprocedural contrast-enhanced cardiac computed tomography and optically-tracked 3D transthoracic echocardiography data to better define the planning target volume for stereotactic arrhythmia radioablation therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Arrythmia, run by University of Luebeck at 1 site in Germany.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of algorithm training to achieve improved arrhythmogenic substrate characterization (time frame: 1 month after complete data collection). The study lists 2 primary outcomes in all. 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 29 Aug 2024.