# Personalised Risk scOre For Implantation of Defibrillators in Patients With Preserved LVEF>35% and a High Risk for Sudden Cardiac Death

> **NCT04540289** · NA · WITHDRAWN · sponsor: **Helios Health Institute GmbH**

## Conditions studied

- Myocardial Infarction
- Sudden Cardiac Death

## Interventions

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

## Key facts

- **NCT ID:** NCT04540289
- **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- **Status:** WITHDRAWN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:** trial is not feasible (very low event rates, no available risk predictor with acceptable predictive performance for discrimination of high-risk patients)
- **Last updated:** 2023-03-08


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04540289

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04540289, "Personalised Risk scOre For Implantation of Defibrillators in Patients With Preserved LVEF>35% and a High Risk for Sudden Cardiac Death". Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/clinical/NCT04540289. Licensed CC0.

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