# SynCardia Companion 2 Driver System Post Approval Study Protocol With INTERMACS™-Based Data Collection

> **NCT01919320** · — · UNKNOWN · sponsor: **SynCardia Systems. LLC** · enrollment: 500 (estimated)

## Conditions studied

- Bi-ventricular Failure

## Interventions

- **DEVICE:** C2 Driver System TAH-t Patients
- **DEVICE:** CSS Console TAH-t Patients

## Key facts

- **NCT ID:** NCT01919320
- **Lead sponsor:** SynCardia Systems. LLC
- **Sponsor class:** INDUSTRY
- **Phase:** —
- **Study type:** OBSERVATIONAL
- **Status:** UNKNOWN
- **Start date:** 2013-12
- **Primary completion:** 2022-12
- **Final completion:** 2023-07
- **Target enrollment:** 500 (ESTIMATED)
- **Last updated:** 2020-10-23


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01919320

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01919320, "SynCardia Companion 2 Driver System Post Approval Study Protocol With INTERMACS™-Based Data Collection". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT01919320. Licensed CC0.

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