CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 37 enrolled
Drug / intervention
Keystone Heart Embolic Deflection Devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01448421
NCT01448421N/ACompleted
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A Prospective, Single Arm Feasibility Study to Evaluate the Safety and Performance of the Keystone Heart Embolic Deflection Device in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR)

Keystone Heart·interventional·Posted Oct 7, 2011·Updated Sep 14, 2020

In Brief

A clinical study evaluating Keystone Heart Embolic Deflection Device for Aortic Stenosis. Completed, enrolled 37 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Stenosis
Countries--
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 7, 2011
Enrollment StartMar 1, 2012
Primary CompletionJun 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.7 years ago

Interventions

Keystone Heart Embolic Deflection Devicedevice

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.