Mitral Regurgitation Functional
Conditions
Keywords
Mitral Regurgitation, transcatheter mitral valve repair, MitraClip
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.
Interventions
DEVICEMitraClip implantation
Device to approximate the mitral valve leaflets
Sponsors
Abbott
Asklepios proresearch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multi-center, randomized, parallel-arm trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* patients with primary regurgitation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| regurgitation | 1-year | freedom from recurrence of mitral regurgitation (\>2+; 1-year) |
| success rate | 1-year | procedural success rate in 2-clip arm |
| procedure duration | 1-year | procedure duration |
| total device time | 1-year | total device time |
| fluoroscopy time | 1-year | fluoroscopy time |
| contrast volume | 1-year | contrast volume |
| death | 1 year | freedom from death (1-year) |
| 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). |
| 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. |
| NYHA | 1-year | NYHA functional class |
| 6-minutes walk | 1-year | 6-minutes walk distance |
| 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. |
| complications | 1-year | periprocedural (30-day) complications |
| heart failure | 1 year | freedom from heart failure (1-year) |
| rehospitalization | 1-year | rehospitalization |
Outcome results
None listed