# Safety and Performance Study of the Siello S Pacing Lead

> **NCT01791127** · — · TERMINATED · sponsor: **Biotronik, Inc.** · enrollment: 1758 (actual)

## Conditions studied

- Safety and Effectiveness of the Siello S Lead

## Interventions

- **DEVICE:** market-released BIOTRONIK pacemaker system including one or two Siello S leads.

## Key facts

- **NCT ID:** NCT01791127
- **Lead sponsor:** Biotronik, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** —
- **Study type:** OBSERVATIONAL
- **Status:** TERMINATED
- **Start date:** 2013-03-13
- **Primary completion:** 2019-04-17
- **Final completion:** 2019-04-17
- **Target enrollment:** 1758 (ACTUAL)
- **Why stopped:** On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing SIELLO Post Approval Registry to a new EP PASSION real-world data methodology.
- **Last updated:** 2020-06-01


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01791127

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01791127, "Safety and Performance Study of the Siello S Pacing Lead". Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/clinical/NCT01791127. Licensed CC0.

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