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Completed

NCT Number: NCT05331716

Modification 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.

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Key information

Conditions

Ventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Krankenhaus Landshut Achdorf

Landshut, Bavaria, 84036, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

therapy refractory ventricular arrhythmia

Exclusion criteria

none

Treatment and study plan

Cardiac ablation therapy

Procedure

In a subset of patients with known therapy refractory arrhythmia sole LAVA modification is fashioned

Other names: LAVA modification

Primary outcomes

  1. 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)

  2. appropriate therapy delivered by defibrillator (ICD)

    Time frame: 12 months

    appropriate therapy (shock, ATP) delivered by ICD in participants during follow-up period

  3. death

    Time frame: 12 months

    patient succumbed due to malignant ventricular arrhythmia or therapy

Secondary outcomes

  1. death any cause

    Time frame: 36 months

    death any cause during observation period

Sponsors and collaborators

Lead sponsor

University of Kiel

Other

Collaborators

  • Krankenhaus Landshut Achdorf

Registry information

Official study title

Substrate Based Modification in Ventricular Tachycardia: Ablation of the Local Abnormal Ventricular Activity Only

Acronym: LAVAONLY

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 18, 2022
Registry last updated
Oct 7, 2022

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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