CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18 enrolled
Drug / intervention
HAART 300 Annuloplasty 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/NCT01400841
NCT01400841N/ACompleted

A Prospective, Non-randomized, Multi-center Trial to Evaluate the Safety and Effectiveness of the HAART Model 300 Annuloplasty Ring When Used to Surgically Repair a Leaking Aortic Valve Using a 3-D Intra-annular Mounting Frame

Biostable Science & Engineering·interventional·Posted Jul 22, 2011·Updated Jan 13, 2017

In Brief

A clinical study evaluating HAART 300 Annuloplasty Device for Aortic Regurgitation. Completed, enrolled 18 participants across 4 sites in 3 countries.

Detailed Summary

This investigation is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART model 300 annuloplasty ring when used to surgically repair a leaking aortic valve using a 3-D intra-annular mounting frame

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Czechia, Germany
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 22, 2011
Enrollment StartJan 1, 2012
Primary CompletionApr 1, 2013
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.9 years ago

Interventions

HAART 300 Annuloplasty Devicedevice

Implantation of device for aortic valve repair