Ventricular TachycardiaLAVAONLYNCT05331716
Modification of the Local Abnormal Ventricular Activity Only
An observational study of Ventricular Tachycardia, run by University of Kiel at 1 site in Germany.
Trial summary
Local abnormal ventricular activity (LAVA) is composed of high-frequency, mainly low voltage signals that represent near-field signals from slow-conducting tissue and thus potential VT isthmuses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Cardiac ablation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2019to 31 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all consecutive patients undergone LAVA modification alone for treatment of therapy refractory ventricular arrhythmia
Who may be able to join
- therapy refractory ventricular arrhythmia
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Substrate Based Modification in Ventricular Tachycardia: Ablation of the Local Abnormal Ventricular Activity Only
Local abnormal ventricular activity (LAVA) is composed of high-frequency, mainly low voltage signals that represent near-field signals from slow-conducting tissue and thus potential VT isthmuses. The identification of LAVA potentials and their modification have usually been a complimentary component of the substrate-based modification of scar related ventricular arrhtyhmias. With better identification through technical solutions and improved algorithms, LAVA modification may be feasible for treatment in therapy refractory VT.
Read the detailed description
As of 2019 we started LAVA modification only in a subset of patients with therapy refractory ventricular tachycardia. The cohort icludes 55% patient with ischemic cardiomyopathy and 45% with dilated cardiomyopathy. 80% are ICD recipients. These patients were now retrospectively analysed in depth. The endpoint is time to relapse of ventricular tachycardia or ICD shock or death due to malignant arrhythmia. We evaluated all patients we treated accordingly from March 2019 through October 2020. No patient was excluded.
- Conditions
- Ventricular Tachycardia
- Being tested
- Cardiac ablation therapy
- Keywords
- local abnormal ventricular activity, substrate modification, electrophysiology, LAVA, decremental
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac ablation therapyProcedure or surgery
Also called LAVA modification
In a subset of patients with known therapy refractory arrhythmia sole LAVA modification is fashioned
What is being measured
The primary outcome is the main question the study is designed to answer.
VT
occurrence/documentation of ventricular arrhythmia in participant after substrate modification during follow-up period (either Holter ECG or defibrillator interogation or ILR/ICM or electrophysiology study)
Measured: 12 months
appropriate therapy delivered by defibrillator (ICD)
appropriate therapy (shock, ATP) delivered by ICD in participants during follow-up period
Measured: 12 months
death
patient succumbed due to malignant ventricular arrhythmia or therapy
Measured: 12 months
Secondary outcomes (1)
death any cause
death any cause during observation period
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start1 Jan 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kiel
- Sponsor type
- University, hospital or other
- Collaborators
- Krankenhaus Landshut Achdorf
- Responsible party
- Principal investigator, Prof. Dr. Hendrik Bonnemeier, University of Kiel
- Investigators
- Hendrik Bonnemeier, PhD, Study director, University of Kiel - Medical FacultyStefan Borov, MD, Principal investigator, University of Kiel - Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331716
- Sponsor's protocol ID
- 2021-1232
- Acronym
- LAVAONLY
- Status last verified
- Oct 2022
- First submitted
- 4 Apr 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Spreadsheet with characteristics (e.g.; procedure time, etc)
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substrate Based Modification in Ventricular Tachycardia: Ablation of the Local Abnormal Ventricular Activity Only
- ClinicalTrials.gov ID
- NCT05331716
- Acronym / sponsor ID
- LAVAONLY / 2021-1232
- Conditions
- Ventricular Tachycardia
- Keywords
- local abnormal ventricular activity, substrate modification, electrophysiology, LAVA, decremental
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of KielUniversity, hospital or other
- Collaborators
- Krankenhaus Landshut Achdorf
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Apr 2022 (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.
Local abnormal ventricular activity (LAVA) is composed of high-frequency, mainly low voltage signals that represent near-field signals from slow-conducting tissue and thus potential VT isthmuses. The identification of LAVA potentials and their modification have usually been a complimentary component of the substrate-based modification of scar related ventricular arrhtyhmias. With better identification through technical solutions and improved algorithms, LAVA modification may be feasible for treatment in therapy refractory VT.
Detailed description
As of 2019 we started LAVA modification only in a subset of patients with therapy refractory ventricular tachycardia. The cohort icludes 55% patient with ischemic cardiomyopathy and 45% with dilated cardiomyopathy. 80% are ICD recipients. These patients were now retrospectively analysed in depth. The endpoint is time to relapse of ventricular tachycardia or ICD shock or death due to malignant arrhythmia. We evaluated all patients we treated accordingly from March 2019 through October 2020. No patient was excluded.
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
- all consecutive patients undergone LAVA modification alone for treatment of therapy refractory ventricular arrhythmia
Key inclusion criteria (1 listed)
- therapy refractory ventricular arrhythmia
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac ablation therapyAlso: LAVA modificationIn a subset of patients with known therapy refractory arrhythmia sole LAVA modification is fashioned | Procedure or surgery | – |
Primary outcome
VT
Time frame: 12 months
occurrence/documentation of ventricular arrhythmia in participant after substrate modification during follow-up period (either Holter ECG or defibrillator interogation or ILR/ICM or electrophysiology study)
appropriate therapy delivered by defibrillator (ICD)
Time frame: 12 months
appropriate therapy (shock, ATP) delivered by ICD in participants during follow-up period
death
Time frame: 12 months
patient succumbed due to malignant ventricular arrhythmia or therapy
1 secondary outcome
death any cause
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Individual participant dataSharing planned: Yes. Spreadsheet with characteristics (e.g.; procedure time, etc)
Related trials for Ventricular Tachycardia
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MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
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Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
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A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
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SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
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.
Hendrik Bonnemeier, PhD study director
University of Kiel - Medical Faculty
Stefan Borov, MD principal investigator
University of Kiel - Medical Faculty
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 Tachycardia, run by University of Kiel 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Oct 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VT (time frame: 12 months). The study lists 3 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 7 Oct 2022.