At a glance
ClinicalIndex Comparison RecordN/ACompleted· 20 enrolled
Drug / intervention
HAART 200 Aortic Valve 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.
HAART 200 Aortic Valve Annuloplasty During Bicuspid Aortic Valve Reconstruction Trial
In Brief
A clinical study evaluating HAART 200 Aortic Valve Annuloplasty Device for Aortic Insufficiency. Completed, enrolled 20 participants across 4 sites.
Detailed Summary
The HAART 200 "Aortic Annuloplasty during Bicuspid Aortic Valve Reconstruction" Trial is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART 200 bicuspid annuloplasty ring when used to surgically stabilize the aortic valve annulus in patients undergoing repair of bicuspid aortic valves (BAV) for predominant aortic insufficiency (AI).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Insufficiency
CountriesGermany
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartSep 2013
First PostedFeb 2014
Primary CompletionApr 2015
Study CompletionAug 2016
TodayJul 2026
First PostedFeb 26, 2014
Enrollment StartSep 1, 2013
Primary CompletionApr 1, 2015
Study CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.3 years ago
Interventions
HAART 200 Aortic Valve Annuloplasty Devicedevice
Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .