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

NCT02895737 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2021-03-04

No results posted yet for this study

Summary

This prospective, randomized study was designed to analyse the difference of cerebral embolization in patients undergoing transcatheter aortic valve implantation with balloon-expandable vs. self-expandable valves by using a cerebral protection system (Sentinel™ Device).

Conditions

  • 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

Sponsors & Collaborators

  • Deutsches Herzzentrum Muenchen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-28
Primary Completion
2021-12-31
Completion
2022-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02895737 on ClinicalTrials.gov