Noninferiority Trial of MitraClip Implantation Strategies: 1 Clip vs. 2 Clips in Patients With Functional Mitral Regurgitation
- Conditions
- Mitral Regurgitation Functional
- Interventions
- Device: MitraClip implantation
- Registration Number
- NCT03503851
- Lead Sponsor
- Asklepios proresearch
- Brief Summary
Implantation of the MitraClip has become the most frequently used percutaneous technique to treat significant (grade 3+ or 4+) mitral regurgitation (MR) in elderly patients deemed inoperable or at high surgical risk. In Europe, about two-thirds of patients treated with the MitraClip suffer from MR of functional origin secondary to ischemic or dilated cardiomyopathy. At present, there is debate among operators on whether stabilizing/supporting a single adequately implanted clip with a second clip is beneficial for patients with functional MR.
- Detailed Description
Implantation of the MitraClip has become the most frequently used percutaneous technique to treat significant (grade 3+ or 4+) mitral regurgitation (MR) in elderly patients deemed inoperable or at high surgical risk. In Europe, about two-thirds of patients treated with the MitraClip suffer from MR of functional origin secondary to ischemic or dilated cardiomyopathy. At present, there is debate among operators on whether stabilizing/supporting a single adequately implanted clip with a second clip is beneficial for patients with functional MR.
Purpose To demonstrate the noninferiority of a 1-clip strategy vs. a 2-clip strategy of MitraClip implantation, when the second clip in the 2-clip study arm is implanted for stabilizing/supporting purposes.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Absence of a structural abnormality of the mitral valve giving rise to MR.
- MR severity of US grade 3+ or 4+ of central or noncentral origin
- Patient must consent to randomization in the hybrid operating theater upon successful implantation of a single MitraClip. Written informed consent must be provided prior to the MitraClip procedure.
- patients with primary regurgitation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description One CLIP MitraClip implantation Implantation of single MitraClip Two CLIPs MitraClip implantation Implantation of second MitraClip (after successful Implantation of single MitraClip)
- Primary Outcome Measures
Name Time Method Evaluation of number of participants who died death within one year 1 year death
Evaluation of number of rehospitalizations due to heart failure among patients receiving one or two clips 1 year heart failure rehospitalization
Evaluation of number of participants with recurrent regurgitation within one year 1 year recurrence of mitral regurgitation (\>grade 2+ at 1 year)
- Secondary Outcome Measures
Name Time Method heart failure 1 year freedom from heart failure (1-year)
total device time 1-year total device time
NYHA 1-year NYHA functional class
6-minutes walk 1-year 6-minutes walk distance
fluoroscopy time 1-year fluoroscopy time
changes in echocardiographic variables 1-year Changes from baseline to 12 months in echocardiographically assessed (at both time points) LV end-diastolic diameter and volume; LV end-systolic diameter and volume; LV ejection fraction; and forward stroke volume.
quality of life 1-year Assessment of the Minnesota Living With Heart Failure Questionnaire (MLHFQ) quality-of-life score. The questionnaire consists of 21 quality-of-life questions to be answered by the patient on a grading scale of 0 (best) to 5 (worst). Thus, the overall MLHFQ score ranges from 0 to 105.
rehospitalization 1-year rehospitalization
regurgitation 1-year freedom from recurrence of mitral regurgitation (\>2+; 1-year)
contrast volume 1-year contrast volume
death 1 year freedom from death (1-year)
success rate 1-year procedural success rate in 2-clip arm
procedure duration 1-year procedure duration
complications 1-year periprocedural (30-day) complications
echocardiographic variables 1-year The following echocardiographic variables will be assessed by 2-dimensional transthoracic echocardiography at 12 months: Left ventricular (LV) end-diastolic diameter and volume; LV end-systolic diameter and volume; LV ejection fraction; LV outflow tract diameter and velocity time integral in LV outflow tract (to calculate forward stroke volume).