Observational Study of the Heart Repair Technologies Mitral Bridge in Treating Mitral Valve Regurgitation (HRT)
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|ClinicalTrials.gov Identifier: NCT03511716|
Recruitment Status : Terminated (Could not enroll enough patients and ran out of $$ to manufacture more devices)
First Posted : April 30, 2018
Last Update Posted : October 8, 2020
|Condition or disease||Intervention/treatment|
|Mitral Regurgitation||Device: HRT Mitral Bridge Mitral Valve Repair|
The primary objective of this study is to evaluate the safety and performance of the Mitral Bridge device in the correction of mitral valve regurgitation in patients who qualify for mitral valve repair as defined by the American Society of Echocardiography (ASE). The device is a single use, mitral valve implant designed to reduce mitral regurgitation by reducing the septo-lateral mitral annular diameter, promoting early coaptation of the valve leaflets and restraining the leaflets below the intra-annular plane.
The protocol was designed as a First In Man (FIM) with a 6-month follow up but was amended to follow the enrolled patients for a total of 5 years.
|Study Type :||Observational|
|Actual Enrollment :||34 participants|
|Official Title:||HRT Observational Study of a Mitral Bridge in Patients With Moderate to Severe Mitral Valve Regurgitation to Evaluate Device Safety and Performance|
|Actual Study Start Date :||February 6, 2014|
|Actual Primary Completion Date :||August 2019|
|Actual Study Completion Date :||August 31, 2019|
- Device: HRT Mitral Bridge Mitral Valve Repair
Surgical mitral valve implant intended to reduce mitral regurgitation by direct reduction of the septo-lateral mitral annular diameter, promoting early coaptation of the valve leaflets and restraining the leaflets below the intra-annular plane
- Clinical Success [ Time Frame: One, 3, 6,12, 24, 36, 48, and 60 months ]- Freedom from subsequent open mitral valve repair or replacement
- Preservation or improvement of left ventricular remodeling [ Time Frame: One, 3, 6,12, 24, 36, 48, and 60 months ]Change in Left Ventricular status
- Preservation of improvement in NYHA (New York Heart Association) functional class. [ Time Frame: One, 3, 6,12, 24, 36, 48, and 60 months ]Change in NYHA (New York Heart Association) functional class.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511716
|Na Homolce Hospital|
|Prague, Homolka, Czechia, 5|
|Principal Investigator:||Štěpán ČERNÝ, MD, PhD, MBA||Cardiac Surgeon, Head of Hybrid Operating Room,|