Modification of the Local Abnormal Ventricular Activity Only

Completed

• Conditions: Ventricular Tachycardia

• Registration Number: NCT05331716
• Lead Sponsor: University of Kiel

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.

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 Timeline

• Study Start: 2019-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-18
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-06
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

therapy refractory ventricular arrhythmia

Exclusion Criteria

none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VT	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)	12 months	appropriate therapy (shock, ATP) delivered by ICD in participants during follow-up period
death	12 months	patient succumbed due to malignant ventricular arrhythmia or therapy

Secondary Outcome Measures

Name	Time	Method
death any cause	36 months	death any cause during observation period

Trial Locations

Locations (1)

Krankenhaus Landshut Achdorf; 🇩🇪 Landshut, Bavaria, Germany