Suspended
CLEAN-TAVICLaret Embolic Protection ANd TAVI - Trial
What is being tested
TAVI (Medtronic CoreValve)
+ Claret-Filter
+ TAVI (Medtronic CoreValve)
Device
Who is being recruted
Over 18 Years
+8 Eligibility Criteria
How is the trial designed
Supportive Care Study
Interventional
Study Start: April 2013
Summary
Principal SponsorUniversity of Leipzig
Last updated: May 5, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2013
Actual date on which the first participant was enrolled.This prospective, randomized study was designed to investigate the benefit of using a Filter-Protection-Device (Claret MontageTM Dual Filter System) during transcatheter aortic valve implantation (TAVI) with a Medtronic CoreValve®.
Principal SponsorUniversity of Leipzig
Last updated: May 5, 2015
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
1 inclusion criteria required to participate
Subject must be scheduled to undergo an endovascular aortic valve prosthesis (Medtronic CoreValve) implant procedure with the femoral artery as the intended access site for the valve delivery system
7 exclusion criteria prevent from participating
Carotic stenosis > 70%
Expected Non-compliance for follow-ups
Patient is already recruited for another study
Patient is unsuitable for TAVI
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Patient is treated with Cerebral protection Filter.
Group II
Patient is not treated with Cerebral protection Filter.
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
SuspendedOne Study Center