Modification of the Local Abnormal Ventricular Activity Only

Ventricular Tachycardia Clinical Trial

— LAVAONLY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05331716
• Other study ID #: 2021-1232
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2022
• Source: University of Kiel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

therapy refractory ventricular arrhythmia

Exclusion Criteria:

none

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Procedure:
• Cardiac ablation therapy
In a subset of patients with known therapy refractory arrhythmia sole LAVA modification is fashioned

Locations

Country	Name	City	State
Germany	Krankenhaus Landshut Achdorf	Landshut	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
University of Kiel	Krankenhaus Landshut Achdorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	appropriate therapy delivered by defibrillator (ICD)	appropriate therapy (shock, ATP) delivered by ICD in participants during follow-up period	12 months
Primary	death	patient succumbed due to malignant ventricular arrhythmia or therapy	12 months
Secondary	death any cause	death any cause during observation period	36 months