A Randomized Study of the MitraClip Device in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation (RESHAPE-HF)
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|ClinicalTrials.gov Identifier: NCT01772108|
Recruitment Status : Terminated (As recruitment rate was lower than anticipated)
First Posted : January 21, 2013
Last Update Posted : November 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases||Device: MitraClip||Not Applicable|
This study is a clinical evaluation of the safety and effectiveness of the MitraClip System in the treatment of clinically significant functional mitral regurgitation in patients with chronic heart failure. The objective was to further study the safety and effectiveness of the MitraClip System for the treatment of clinically significant functional mitral regurgitation in New York Heart Association Functional Class III or IV chronic heart failure patients.
Due to lower than expected recruitment rate, Abbott Vascular sponsorship of the trial was terminated early.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Study of the MitraClip Device in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||January 2015|
Experimental: MitraClip Device
Subjects randomized to the Device group will undergo the MitraClip procedure in addition to optimal standard medical therapy.
The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
No Intervention: Control
Subjects randomized to the Control group will receive optimal standard of care therapy alone.
- Hierarchical composite of all-cause mortality and recurrent heart failure hospitalizations [ Time Frame: two years ]The analysis will be carried out when the last patient completes 12-month follow-up. All follow-up, up to 24 months, will be included in the analysis.
- Composite of all-cause mortality, stroke, myocardial infarction, new need for renal replacement therapy, and non-elective cardiovascular surgery for device related complications in the Device group at 30 days [ Time Frame: 30 days ]
- Mitral regurgitation severity reduction to mild or mild-to-moderate at 12 months [ Time Frame: 12 months ]
- Change in Left Ventricular End Diastolic Volume (LVEDV) at 12 months over baseline [ Time Frame: 12 months ]
- Change in Left Ventricular End Systolic Volume (LVESV) at 12 months over baseline [ Time Frame: 12 months ]
- Change in 6 Minute Walk Test (6MWT) distance at 12 months over baseline [ Time Frame: 12 months ]
- Change in Quality of Life (QoL) score, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ), at 12 months over baseline [ Time Frame: 12 months ]
- New York Heart Association (NYHA) Functional Class I/II at 12 months [ Time Frame: 12 months ]
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): NCT01772108
|Principal Investigator:||Piotr Ponikowski, MD, PhD||Military Hospital, Medical University, Wroclaw, Poland|