At a glance
ClinicalIndex Comparison RecordN/ACompleted· 505 enrolled
Drug / intervention
MitraClip +1 moredevice
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.
Randomised Investigation of the MitraClip Device in Heart Failure: 2nd Trial in Patients With Clinically Significant Functional Mitral Regurgitation
In Brief
A clinical study evaluating MitraClip and standard of care for Mitral Valve Insufficiency. Completed, enrolled 505 participants across 35 sites in 9 countries.
Detailed Summary
To study the safety and effectiveness of the MitraClip System in the treatment of clinically significant functional mitral regurgitation in patients with New York Heart Association (NYHA) Functional Class II to Class IV chronic heart failure.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMitral Valve Insufficiency
CountriesCzechia, Denmark, Germany, Greece, Italy, Poland, Portugal, Spain, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartMar 2015
First PostedMay 2015
Primary CompletionApr 2024
TodayJul 2026
First PostedMay 14, 2015
Enrollment StartMar 1, 2015
Primary CompletionApr 19, 2024
TodayJul 2, 2026
Enrollment to primary: 9.1 yearsPosted 11.1 years ago
Interventions
MitraClipdevice
Implantation of the MitraClip System for patients with chronic heart failure.
standard of careother