NCT04765943: TeVeO

Prognosis Impact of NSVTs After an AMI (TeVeO Study).

Active, enrolled Last updated 21 March 2025

What this trial tests

trial testing Implantable Loop Recorder implant in Death, Sudden in 224 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 August 2020

Primary endpoint
5 July 2023

30 June 2025

Quick facts

Lead sponsor	Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	224
Start date	15 August 2020
Primary completion	5 July 2023
Estimated completion	30 June 2025
Sites	1 location across Spain

Drugs / interventions tested

• Implantable Loop Recorder implant

Conditions studied

• Death, Sudden — all drugs for Death, Sudden →
• Ventricular Tachycardia — all drugs for Ventricular Tachycardia →
• Implantable Defibrillator User — all drugs for Implantable Defibrillator User →
• Myocardial Infarction — all drugs for Myocardial Infarction →

Sponsor

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León — full company profile →

Who can join

18 and older, any sex, with Death, Sudden or Ventricular Tachycardia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Nowadays, Sudden Cardiac Death (SCD) due to malignant arrhythmias is an important cause of death among acute myocardial infarction (AMI) survivors. Preventive strategies with implantable cardioverter-defibrillators (ICD) are the best clinical option for patients, but associated sociosanitary impact in the National Health Systems and the fact that current implant strategy not always results in benefits for the patient requires to develop further selection criteria. The TeVeO project aims to study the events that take place early following an AMI to predict the short- and long-term risk of experiencing a potentially lethal ventricular tachycardia (VT). The project will carry out an observational and multicentric study involving 5 different hospitals to: a) qualitative and quantitative characterize non-sustained VTs (NSVT) that take place during the first 6 months after an AMI and b) characterize the evolution of the substrate (scar and surrounding tissue) in patients meeting criteria for ICD implant. Patients included in the study will be implanted with an implantable loop recorder (ILR) in order to register NSVT and cMRI images will be acquired prior to hospital discharge and at 6 months after AMI to study the substrate. Further patients' management will follow the protocols within each entity. Project results will allow us to stratify patients according to identified risks for developing malignant VT, which will improve patient selection for ICD implantation and will contribute to tailor patients' treatment and prevention, improving the cost-effectiveness of these devices and minimizing their associated problems and sociosanitary burden.

Publications & conference data

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

1. Prospective study of continuous rhythm monitoring in patients with early post-infarction systolic dysfunction: clinical impact of arrhythmias detected by an implantable cardiac monitoring device with real-time transmission-the TeVeO study protocol.
   Hernandez-Hernandez J, Cruz-Galban A, Duran-Bobin O, Garcia-Seara J, et al · · 2025 · PMID 40316360 · DOI 10.1136/bmjopen-2024-094764