NCT05086510

Ablation Targets of Scar-related Ventricular Tachycardia Identified by Dynamic Functional Substrate Mapping

Completed NA Results posted Last updated 20 February 2024

What this trial tests

NA trial testing Radiofrequency ablation in Tachycardia, Ventricular in 40 participants. Completed in 26 June 2023.

Timeline

28 October 2021

Primary endpoint
26 June 2023

26 June 2023

Quick facts

Lead sponsor	Ain Shams University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	28 October 2021
Primary completion	26 June 2023
Estimated completion	26 June 2023
Sites	1 location across Egypt

Drugs / interventions tested

• Radiofrequency ablation

Conditions studied

• Tachycardia, Ventricular — all drugs for Tachycardia, Ventricular →

Sponsor

Ain Shams University

Who can join

Eligibility, any sex, with Tachycardia, Ventricular. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Recurrence of Ventricular Tachycardia Primary · 12 months

Recurrence of ventricular tachycardia implies receiving at least one appropriate implantable cardioverter defibrillator therapy or hospital admission due to symptomatic ventricular tachycardia.

Group	Value	95% CI
Non-DEEP Group	13
DEEP Group	13

Number of Participants Who Experience Cardiac Death Secondary · 12 months

This is defined as unexpected death where a cardiac cause is the most probable etiology

Group	Value	95% CI
Non-DEEP Group	5
DEEP Group	4

Number of Participants Who Die From Any Cause (All-cause Mortality) Secondary · 12 months

This includes death from any cause

Group	Value	95% CI
Non-DEEP Group	5
DEEP Group	4

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Non-DEEP Group

Serious: 3/20 (15%)

Deaths: 5/20

DEEP Group

Serious: 3/20 (15%)

Deaths: 4/20

Serious adverse events (4 terms)

Reaction	System	Non-DEEP Group	DEEP Group
Cardiac tamponade	Cardiac disorders	—	—
Ventricular fibrillation	Cardiac disorders	—	—
heart block	Cardiac disorders	—	—
pulmonary edema	Cardiac disorders	—	—

Most-reported serious reactions: Cardiac tamponade, Ventricular fibrillation, heart block, pulmonary edema.

Data from ClinicalTrials.gov NCT05086510 adverse events section.

Sponsor's own description

This study aims at comparing the recurrence rates of ventricular tachycardia ablated after being mapped by 2 different techniques.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Ablation targets of scar-related ventricular tachycardia identified by dynamic functional substrate mapping.
   Elewa MG, Altoukhy S, Badran HA, El Damanhoury H, et al · · 2023 · cited 1× · PMID 37831212 · DOI 10.1186/s43044-023-00414-w