# PROTECT TAVI - Prospective Randomized Outcome Study in TAVI Patients Undergoing Periprocedural Embolic Cerebral Protection With the Sentinel™ Device

> **NCT02895737** · NA · UNKNOWN · sponsor: **Deutsches Herzzentrum Muenchen** · enrollment: 328 (estimated)

## Conditions studied

- Cerebral Embolization During TAVI Using Balloon-expandable vs. Self-expandable Valves

## Interventions

- **DEVICE:** TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra
- **DEVICE:** TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra; Sentinel™ Cerebral Protection Systems
- **DEVICE:** TAVI: CoreValve® Evolut R™, CoreValve Medtronic
- **DEVICE:** TAVI: CoreValve® Evolut R™, CoreValve Medtronic; Sentinel™ Cerebral Protection Systems

## Key facts

- **NCT ID:** NCT02895737
- **Lead sponsor:** Deutsches Herzzentrum Muenchen
- **Sponsor class:** OTHER
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** UNKNOWN
- **Start date:** 2016-12-28
- **Primary completion:** 2021-12
- **Final completion:** 2022-06
- **Target enrollment:** 328 (ESTIMATED)
- **Last updated:** 2021-03-04


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02895737

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02895737, "PROTECT TAVI - Prospective Randomized Outcome Study in TAVI Patients Undergoing Periprocedural Embolic Cerebral Protection With the Sentinel™ Device". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT02895737. Licensed CC0.

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