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DEFLECT I: Keystone Heart Embolic Deflection Trial

NCT01448421 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2020-09-14

Study results available
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Summary

This is a research study using the Keystone Heart Embolic Deflection Device and involving patients with aortic stenosis (a disease of the aortic valve), to be treated with Transcatheter Aortic Valve Replacement (TAVR).

The TAVR procedure consists in replacing the diseased aortic valve by a new artificial valve. The new valve is put into place using a long, thin tube called a catheter that is inserted into a small incision (cut) in the patient's groin and threaded through his/her arteries up to the heart.

Conditions

  • Aortic Stenosis

Interventions

DEVICE

Keystone Heart Embolic Deflection Device

The Keystone Heart Embolic Deflection Device is used in the aortic arch to deflect and to reduce embolic material (debris/thrombus) to the cerebral/carotid arteries during endovascular procedures.

Sponsors & Collaborators

  • Keystone Heart

    lead INDUSTRY

Principal Investigators

  • Michael Mullen, Md. · The Heart Hospital, London, UK

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-06-30
Completion
2014-01-31

More Related Trials

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 NCT01448421 on ClinicalTrials.gov