Modification of the Local Abnormal Ventricular Activity Only

NCT05331716 | Completed DMC

• 1 other identifier: 2021-1232
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ventricular Tachycardia

Keywords

local abnormal ventricular activity; substrate modification; electrophysiology; LAVA; decremental

Outcome Measures

Primary Outcomes (3)

• 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)

  12 months

• appropriate therapy delivered by defibrillator (ICD)

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

  12 months

• death

  patient succumbed due to malignant ventricular arrhythmia or therapy

  12 months

Secondary Outcomes (1)

• death any cause

  36 months

Interventions

Cardiac ablation therapy PROCEDURE

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

Also known as: LAVA modification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• therapy refractory ventricular arrhythmia

You may not qualify if:

• none

Sponsors & Collaborators

• University of Kiel: lead
• Krankenhaus Landshut Achdorf: collaborator

Study Sites (1)

Krankenhaus Landshut Achdorf

Landshut, Bavaria, 84036, Germany

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

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

Study Officials

• Hendrik Bonnemeier, PhD

  University of Kiel - Medical Faculty

  STUDY DIRECTOR

• Stefan Borov, MD

  University of Kiel - Medical Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating principal investigator

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 18, 2022
• Study Start: January 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

DE (1)