# Personalised Risk scOre For Implantation of Defibrillators in Patients With Reduced LVEF≤35% and a Low Risk for Sudden Cardiac Death

> **NCT04540354** · NA · WITHDRAWN · sponsor: **Helios Health Institute GmbH**

## Conditions studied

- Myocardial Infarction
- Heart Failure
- Sudden Cardiac Death

## Interventions

- **DRUG:** Optimal Medical Therapy (OMT)
- **DEVICE:** Implantable cardioverter-defibrillator (ICD)

## Key facts

- **NCT ID:** NCT04540354
- **Lead sponsor:** Helios Health Institute GmbH
- **Sponsor class:** OTHER
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** WITHDRAWN
- **Start date:** 2021-02-01
- **Primary completion:** 2023-01-31
- **Final completion:** 2023-01-31
- **Target enrollment:** 0 (ACTUAL)
- **Why stopped:** Study design needs to be updated considering the lack of a risk predictor with acceptable predictive performance for the discrimination between high- and low-risk patients and the overall low sudden cardiac death risk as found in the data analysis
- **Last updated:** 2023-03-08


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04540354

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04540354, "Personalised Risk scOre For Implantation of Defibrillators in Patients With Reduced LVEF≤35% and a Low Risk for Sudden Cardiac Death". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT04540354. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*