NCT04061434: OVERCOME

ECG Algorithms for CRT Response Evaluation

Completed Last updated 6 October 2021

What this trial tests

trial in ECG Monitoring in 547 participants. Completed in 30 July 2020.

Timeline

1 March 2019

Primary endpoint
30 July 2020

30 July 2020

Quick facts

Lead sponsor	Medical University of Warsaw
Status	Completed
Study type	OBSERVATIONAL
Enrollment	547
Start date	1 March 2019
Primary completion	30 July 2020
Estimated completion	30 July 2020
Sites	1 location across Poland

Conditions studied

• ECG Monitoring — all drugs for ECG Monitoring →

Sponsor

Medical University of Warsaw

Who can join

Adults 18 to 100, any sex, with ECG Monitoring. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cardiovascular diseases (CVD) are associated with high healthcare costs,as well as are a leading cause of mortality and hospitalizations. One of CVDs is a heart failure which may be associated with dyssynchrony of contraction of right and left ventricle. Chance for group of patients whose pharmacotherapy is not enough is cardiac resynchronisation therapy (CRT). Effectiveness of CRT has been proven in various multicenter clinical studies. The challenge limiting CRT usage is it relative low effectiveness - with significant group of patients that do not respond to this method of therapy. The device itself does not always show the true level of stimulation during interrogation; then invalid functioning is often not detected, which presents a real danger to patient's health and life. The main challenge for today's researchers is to develop new technologies, which may help to improve diagnosis of CVD, thereby reducing healthcare costs and quality of patients' lives. Smart computed systems of ECG analysis and interpretation offer new capabilities for the diagnosis and management of patients with CRT. Several reports with intelligent machine-based learning algorithms have been published, in which achieved very positive results in detecting various ECG abnormalities. Aim of our study is to show utility of ECG interpretation software in patients with CRT to assess the CRT response using Cardiomatics system.

Publications & conference data

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

1. The Use of Machine Learning Algorithms in the Evaluation of the Effectiveness of Resynchronization Therapy.
   Krzowski B, Rokicki J, Główczyńska R, Fajkis-Zajączkowska N, et al · · 2022 · cited 2× · PMID 35050227 · DOI 10.3390/jcdd9010017