# ProMRI AFFIRM Study of the EVIA/ENTOVIS Pacemaker With Safio S Pacemaker Leads

> **NCT01460992** · — · COMPLETED · sponsor: **Biotronik SE & Co. KG** · enrollment: 121 (actual)

## Conditions studied

- Cardiac Disease

## Interventions

- **PROCEDURE:** Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions

## Key facts

- **NCT ID:** NCT01460992
- **Lead sponsor:** Biotronik SE & Co. KG
- **Sponsor class:** INDUSTRY
- **Phase:** —
- **Study type:** OBSERVATIONAL
- **Status:** COMPLETED
- **Start date:** 2012-03
- **Primary completion:** 2013-10
- **Final completion:** 2013-11
- **Target enrollment:** 121 (ACTUAL)
- **Last updated:** 2013-11-28


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01460992

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01460992, "ProMRI AFFIRM Study of the EVIA/ENTOVIS Pacemaker With Safio S Pacemaker Leads". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT01460992. Licensed CC0.

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