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Protect the Head to Head Study

NCT05684146 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2023-05-19

No results posted yet for this study

Summary

Prospective, randomized, open label, multicenter, 2-arm, safety and efficacy study

Conditions

  • Embolism

Interventions

DEVICE

Emboliner Embolic Protection

Emboliner Embolic Protection Device will be used to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) interventions

DEVICE

Sentinel Cerebral Protection

The Sentinel Cerebral Protection System will be used to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) interventions

Sponsors & Collaborators

  • Emboline

    lead INDUSTRY

Principal Investigators

  • Laura A Brenton · Emboline, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-04
Primary Completion
2024-10-31
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States

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 NCT05684146 on ClinicalTrials.gov