At a glance
ClinicalIndex Comparison RecordN/ACompleted· 68 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.
The HAART 300 Annuloplasty Ring Extended Safety and Performance Trial Used in Surgical Repair of the Aortic Valve
In Brief
A clinical study evaluating HAART 300 Annuloplasty Device for Aortic Insufficiency. Completed, enrolled 68 participants across 8 sites in 2 countries.
Detailed Summary
This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D intra-annular mounting frame.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Insufficiency
CountriesCzechia, Germany
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2012
Enrollment StartDec 2012
Primary CompletionJun 2014
Study CompletionNov 2015
TodayJul 2026
First PostedNov 26, 2012
Enrollment StartDec 1, 2012
Primary CompletionJun 1, 2014
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 13.6 years ago
Interventions
HAART 300 Annuloplasty Devicedevice
Implantation of HAART 300 Annuloplasty Device for aortic valve repair