Modification of the Local Abnormal Ventricular Activity Only (LAVAONLY)

October 6, 2022 updated by: Prof. Dr. Hendrik Bonnemeier, University of Kiel

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Landshut, Bavaria, Germany, 84036
        • Krankenhaus Landshut Achdorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all consecutive patients undergone LAVA modification alone for treatment of therapy refractory ventricular arrhythmia

Description

Inclusion Criteria:

therapy refractory ventricular arrhythmia

Exclusion Criteria:

none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months
appropriate therapy delivered by defibrillator (ICD)
Time Frame: 12 months
appropriate therapy (shock, ATP) delivered by ICD in participants during follow-up period
12 months
death
Time Frame: 12 months
patient succumbed due to malignant ventricular arrhythmia or therapy
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
death any cause
Time Frame: 36 months
death any cause during observation period
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kiel

Collaborators

Krankenhaus Landshut Achdorf

Investigators

  • Study Director: Hendrik Bonnemeier, PhD, University of Kiel - Medical Faculty
  • Principal Investigator: Stefan Borov, MD, University of Kiel - Medical Faculty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

April 4, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 18, 2022

Study Record Updates

Last Update Posted (Actual)

October 7, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-1232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Spreadsheet with characteristics (e.g.; procedure time, etc)

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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